Randomised controlled trial of a novel online cognitive rehabilitation programme for children with cerebral palsy: a study protocol

Introduction Cerebral palsy (CP) is the most common cause of physical disability in children, with an estimated 600–700 infants born with CP in Australia each year. CP is typically associated with motor impairments, but nearly half of all children with CP also experience cognitive impairment, potentially impacting educational and vocational achievement. This paper reports the protocol for a randomised controlled trial of a computerised cognitive training intervention based on behavioural principles: Strengthening Mental Abilities through Relational Training (SMART). The study aims to investigate SMART’s effect on fluid reasoning, executive function and academic achievement in children with CP. Methods and analysis Sixty children with mild to moderate CP (Gross Motor Function Classification Scale I–IV) aged between 8 years and 12 years will be recruited. Participants will be randomly allocated to two groups: SMART cognitive training and waitlist control. Families will access the programme at home over a 4-month period. Assessments will be administered at baseline, 20 weeks and at 40 week follow-up for retention. The primary outcome will be fluid intelligence, while academic achievement, executive function and social and emotional well-being will be secondary outcomes. Ethics and dissemination This study has approval from the Children’s Health Queensland Hospital and Health Service Research Ethics Committee (HREC/14/QRCH/377) and The University of Queensland (2017001806). If the computerised cognitive training programme is found to be effective, dissemination of these findings would assist children with CP by providing an accessible, cost-effective intervention that can be completed at home at the individual’s own pace. Registration details The study was registered prospectively on 10 November 2017 to present. Recruitment is now under way, and we aim to complete recruitment by June 2019, with data collection finalised by March 2020. Trial registration number ACTRN12617001550392; Pre-results.

Cerebral palsy (CP), with a prevalence of 1.4 per 1000 live births, 1 is the most common cause of physical disability in children and an estimated 600-700 infants are born with CP in Australia each year. 2 While CP is typically associated with motor impairments, research is now focusing on accompanying cognitive and executive functioning (EF) deficits and how these impact daily living. 3 It is estimated that approximately 45% of children with CP will have an intellectual impairment impacting significantly on educational achievement. [4][5][6][7] This translates to long-term difficulties associated with failure to complete formal education, obtain competitive employment and live independently.
While there is growing awareness of cognitive and EF limitations, interventions for CP are typically associated with improving physical activity, limb function, and participation in daily living activities. 8 Few interventions target cognitive function and academic abilities. 8 For children with CP who live in remote or isolated communities, access to clinic-based interventions is further limited. This study aims to trial a novel online cognitive rehabilitation program for children with CP targeted to improve intellectual functioning, EF, and educational achievement. The program -Strengthening Mental Abilities Through Relational Training (SMART) 9 -is founded upon relational frame theory, which proposes that the development of language and complex reasoning in humans rests upon our ability to derive relations between stimuli arbitrarily and without direct experience. An online program designed to train relational framing ability and potentially improve complex reasoning would be a cost-effective, accessible intervention for children with CP.  5 Cerebral palsy refers to a group of motor disorders, originating in a non-progressive injury or disturbance to the brain. [10][11][12] These disturbances occur early in development, impacting the foetal or infant brain. 11 Cerebral palsy is associated with various types of brain lesions, 13 arising from many different causes, congenital and acquired, including intracranial haemorrhage, asphyxia, prematurity, low birth weight or infection. 14 While motor impairment is a defining feature of CP, more recent definitions acknowledge the frequent comorbidities, such as vision problems, epilepsy, and cognitive and communication difficulties. 14,15 Fewer studies have focused on cognitive impairment in cerebral palsy than on motor impairment, but the research that has been undertaken suggests a significant proportion of individuals with CP have impaired cognitive function. 7 A systematic review of rates of impairment in CP found that 49% of children with CP had an intellectual disability, defined as an IQ below 70, while 28% had a severe intellectual disability, with an IQ below 50. 13 Similarly, a population-based study of more than 1,100 individuals with CP in Australia found 45% had been recorded as having an intellectual disability, although level of impairment could not be determined for many in this sample. 7 It is recognised that although CP is a non-progressive disease, the impact of these additional impairments can exert significant influence over a child's development, impacting academic and vocational outcomes, psychological well-being and quality of life, 13 as well as general health. 7

Fluid Intelligence
Amongst most intelligence researchers, there is broad agreement that intelligence is associated with certain abilities, such as problem solving, understanding abstract ideas, or capacity for learning. [16][17][18] One prominent contemporary model, and one that is highly influential at present in the field of intelligence testing, is the Cattell-Horn-Carroll (CHC) theory of intelligence. 19,20 CHC theory offers a system for classifying cognitive ability that has allowed greater consensus in the literature around what is being measured and referred to by terms such as crystallised and fluid intelligence. 20 Fluid intelligence is a measure of the capacity to solve novel problems and reason abstractly, while crystallised intelligence is a measure of comprehension and acquired knowledge. 21 While in the past, intelligence was considered a stable attribute, more recently, it has been conceptualised as a quality open to change and development. 22 As a result, attention has turned to potential factors that could play a role in determining intelligence, with the aim of developing interventions. 23 Furthermore, by combining technological innovation with proposed models of cognitive plasticity, the possibility of accessible interventions, delivered via computers, iPads or similar devices, has emerged.
Various online cognitive training programs have been developed and many of these have targeted working memory (WM), an executive function that involves the ability to temporarily hold and manipulate information. Some researchers have hypothesised that gains in WM could transfer into gains in fluid intelligence. 24,25 Research into this area is ongoing, and results are mixed. 24 While Jaeggi et al. 25 generated great interest in cognitive training when they reported gains in fluid intelligence after WM training, 26 numerous studies have failed to replicate such transfer effects, 27 and research continues in this field. The novel online cognitive training program to be trialled, Strengthening Mental Abilities through Relational Training (SMART), shows promise in pilot studies in helping improve children's cognitive skills (e.g., ability to learn, think, and reason). 9 SMART is a web-based cognitive training program that directly trains the relational abilities thought to be foundational to complex cognition. SMART is grounded in contextual behavioural science, specifically relational frame theory, 9 which proposes that all human language and complex cognition is underpinned by our ability to relate stimuli arbitrarily. That is, humans can relate stimuli in a manner that does not correspond to the physical properties of the stimuli. These relations between stimuli are called relational frames, and a number exist, such as coordination (e.g., same as), comparative (e.g., more/less), and temporal frames (e.g., before and after). 28 An example of a relational frame of more/less would be with Australian one-and twodollar coins, where individuals can relate stimuli to learn that the two-dollar coin is worth more, even though it is physically smaller than the one-dollar coin.

SMART program
Many relational frames, including spatial (e.g. under), measurement (e.g. bigger) and ordinal (e.g. first) are foundational to mathematics. 29 Repeated exposure to spatial, measurement, ordinal and other mathematics-relevant relational frames is considered a critical part of early education, helping students develop their understanding of mathematical concepts. 29 In addition to learning relational frames, people can also learn behavioural responses through derived relations, not merely through direct experience. 9 Through derived relations, our relational framing abilities greatly enhance our capacity to learn and to interact effectively with others and our environment. As an example, a person might learn that the star Vega is closer to Earth than Canopus, but further than Sirius. They could then derive that Canopus is the furthest star from Earth of the three, even though it has not been directly taught, and Canopus appears brighter than Vega. As relational framing is foundational to complex cognition, the direct training of relational framing itself has the potential to have wide-reaching effects on cognition.
A feasibility pilot study of SMART was conducted over a 9-month period with eight children aged 11-12 years old who had been experiencing educational difficulties at school. 9 Seven of the eight children showed significant increases in their intellectual functioning, as measured by the Wechsler Intelligence Scale for Children -Fourth Edition with scores improving by more than one standard deviation. The underlying cognitive skills trained in the program are required for vocabulary acquisition, mathematical reasoning, and other academic and learning skills. The program can be accessed in the client's home at their convenience via iPad, Mac or PC with Internet access and can be completed at the child's own pace. As such, it is a potentially costeffective solution that can be delivered to children with CP who are unable to access ongoing rehabilitation services.

Specific Aims
The aim of this randomised controlled trial is to test the efficacy of a novel web-based cognitive rehabilitation program for children aged between 8 and 12 years old with mild to moderate congenital CP. Outcomes will be assessed immediately postintervention (20 weeks) and again at 40 weeks post-intervention.

Hypotheses
The primary hypothesis to be tested is that in a randomised controlled trial for children aged 8-12 with CP: 1. Participants in the intervention group will demonstrate improved performance immediately post-intervention on a standardised test of intellectual ability when compared to a waitlist control group receiving care as usual. (Wechsler Intelligence Scale for Children -Fifth Edition; WISC-V) 30,31 The secondary hypotheses to be tested are that the SMART intervention group will demonstrate improvements in the following outcomes: 1. Academic achievement (Wechsler Individual Achievement Test Third Edition; WIAT-III) 32 2. Executive function (Behavior Rating Inventory of Executive Function; BRIEF) 33 3. Social and emotional functioning (Strengths and Difficulties Questionnaire; SDQ; Behavior Assessment System for Children -Third Edition; BASC-3; Social Communication Questionnaire; SCQ;) 34-36 . 4. Attention (Conners -Third edition; Conners-3) 37 . 5. Quality of life (Cerebral Palsy Quality of Life -Child; CP-QOL) 38 .

Study Design
The study is a randomised controlled trial design with waitlist control group, to determine the effectiveness of the SMART program for children with CP aged [8][9][10][11][12] years (see CONSORT flowchart in Figure 1.) After baseline assessment, participants will be randomly allocated to either the intervention or waitlist control group.
The intervention group will commence the SMART program immediately and complete it over the following 16 weeks, before undergoing post-intervention assessment at 20 weeks. The waitlist control group will continue care as usual for 20 weeks before returning for a second assessment visit, at which point they will commence the SMART program.
Participants: We aim to recruit 60 children with mild to moderate CP (Gross Motor Function Classification Scale -GMFCS I -III) aged between 8 and 12 years old. All to the Internet at home, and be able to attend three assessment sessions in Brisbane.
Children will be excluded if they have unstable epilepsy (i.e., not controlled by medication); an unstable brain injury (e.g., degenerative or metabolic condition); and/or active medical condition (e.g., chemotherapy, radiotherapy, or neurosurgical).
Recruitment: Participants will be recruited from a consent-based research database at the Queensland Cerebral Palsy and Rehabilitation Research Centre, and through the Queensland Paediatric Rehabilitation Service at the Queensland Children's Hospital.

Measurement of Outcome:
All children will undergo a comprehensive cognitive, psychoeducational, and psychosocial assessment by a psychologist at baseline (i.e., before treatment), and reassessment at 20 weeks (after intervention for immediate group), and 40 weeks (retention for immediate group, and after intervention for control group). Children will complete the following assessments: Processing Speed Index (PSI), each derived from two subtests. The WISC-V has been found to have good internal consistency (α=.96 for FSIQ and α= .86-.94 for primary index scores). 31 Interrater reliability has also been found to be acceptable (r= .98-.99 for interscorer agreement on a subset of subtests). 30 34 The SDQ produces five subscales: emotional symptoms, conduct problems, inattention/hyperactivity, peer problems and prosocial behaviour (range 0-10), and a total difficulties score (range 0-40). Research suggest that for younger children, internal consistency is acceptable for the total difficulties, emotional symptoms, prosocial behaviour, and inattention/hyperactivity subscales, but not for peer and conduct problems. 39 However, Muris et al. 39 note that the scale can provide useful information about psychopathology in children from eight years old.
Parents will also be administered questionnaires during the three assessments points.
These include:  The Behaviour Rating Inventory of Executive Function (BRIEF) assesses the child's executive functioning in everyday life. The BRIEF is an 85-item parent-rated questionnaire assessing behavioural manifestations of executive functions in everyday life. 33  SDQ is a 25-item parent-report measure of child behaviour and adjustment, with frequency of behaviour rated on a 3-point Likert scale. 34 The SDQ produces five subscales: emotional symptoms, conduct problems, inattention/hyperactivity, peer problems and prosocial behaviour (range 0-10).
It produces a total difficulties score (range 0- 40)  and test-retest reliability (r=.80-.90). 38 Assessments at baseline, 20 and 40 weeks will take approximately two to three hours per session. The waitlist control design ensures all children in the study will receive the intervention within six months of being randomised to either commence the program immediately or after 20 weeks.
At the conclusion of the study, semi-structured interviews will be conducted with children and caregivers to explore their engagement with the online cognitive rehabilitation program and gain qualitative insights into families' experience with the program. Questions will cover what families liked and disliked about the program, how easy they found it was to access at home, and to remain engaged. Interviews will be recorded, transcribed and analysed.
Intervention: With the SMART online platform, participants answer problems directly training relational framing and receive immediate feedback on their answers. Study participants are provided with an alias login name (to maintain confidentiality) and a password. Children are encouraged to complete the SMART intervention for 30 minutes per session, for a total of 1.5 hours per week. SMART is incremented and can be completed at the child's own pace. The full dosage is reached when the child completes the entire intervention, which is expected to occur within 20 weeks.
Throughout the RCT, a psychologist will stay in contact with the family and monitor that child's progress, supporting both parent and child in meeting their goals for completing the program, and maintaining engagement.
A resource guide prepared for this study will be provided to all families. This guide provides technical information on accessing the program, a description of how to work through each stage of the program, and information on how parents can support their child to work on the program, including a visual chart to keep track of progress.
Statistical Analysis: Study hypotheses will be analysed by means of appropriate statistical tests, with statistical significance for all tests set at p<0.05 with adjustment for multiple comparisons, and all analyses will be intention to treat. Mixed analysis of variance analyses will be conducted with time (baseline, 20 weeks and 40 weeks) as the within subjects variable, and group (intervention or waitlist) as the between subjects variable. Secondary analysis will profile cognitive change over time for participants based on their test scores. Power analysis suggests a total sample size of 52 would be sufficient to equate to a medium-large effect size of 0.70 (power 0.8). 41 We aim to recruit 60 children to account for attrition (30 in each group).

Ethics and Dissemination
This study has received full ethical approval from the Children's Health Queensland Hospital and Health Service Research Ethics Committee (HREC/14/QRCH/377) and The University of Queensland (2017001806). Protocol modifications and amendments will be submitted to the ethics committees for approval. This trial has been registered with the Australian New Zealand Clinical Trials Registry, Trial ID: ACTRN12617001550392. Study results will be disseminated through publication in scientific journals and participation in conferences. Families who participate in the study will receive information on the study results, as well as a feedback report on the outcomes of assessments their child has completed. If the computerised cognitive training program is found to be effective, dissemination of these findings would assist children with CP by providing an easily accessible, cost-effective intervention that can be completed at home at the individual's own pace. This protocol paper has reported the background and study design for a randomised controlled trial investigating the effectiveness of a computerised cognitive training program for children with CP. This program has not previously been studied in this population. The research study will assess children's cognitive skills, executive ability and social and emotional functioning, with fluid intelligence the primary outcome of interest. Qualitative information will be gathered on families' experience engaging with the program. Results of the study will be disseminated through peer-reviewed journals and at relevant scientific conferences.

Discussion
Nearly half of all children with CP are estimated to also have an intellectual impairment, impacting academic achievement and ability to achieve educational and vocational goals in the long-term. If this computerised cognitive training program is found to be effective, a flexible, easily accessible intervention will be available for this population, where at present there at few options available for addressing difficulties with cognitive skills in CP.

Author Contributions
The study was designed and established by all the authors. JW is responsible for the ethics application and reporting. JW is responsible for recruitment and data collection.
JW will take a lead role in preparing publications on the clinical outcomes of the study. KW, RB and JS will contribute to the preparation of publications and are providing supervision throughout the study. JW will take on a lead role for statistical analysis. JW drafted the final version of this manuscript, while all authors critically reviewed and approved the final version. JW will use data from this study to contribute to her PhD thesis.

Methods and Analysis
Sixty children with mild to moderate CP (Gross Motor Function Classification Scale -GMFCS I -IV) aged between 8 and 12 will be recruited. Participants will be randomly allocated to two groups: SMART cognitive training and wait list control. Families will access the program at home over a four-month period. Assessments will be administered at baseline, 20 weeks and at 40-week follow-up for retention. The primary outcome will be fluid intelligence, while academic achievement, executive function and social and emotional wellbeing will be secondary outcomes.

Ethics and Dissemination
This study has approval from the Children's Health Queensland Hospital and Health Service Research Ethics Committee (HREC/14/QRCH/377) and The University of Queensland (2017001806). If the computerised cognitive training program is found to be effective, dissemination of these findings would assist children with CP by providing an accessible, cost-effective intervention that can be completed at home at the individual's own pace.

Registration Details
This trial is registered with the Australian New Zealand Clinical Trials Registry, Trial ID: ACTRN12617001550392. The study was registered prospectively on 10 November 2017 to present. Recruitment is now under way and we aim to complete recruitment by June 2019, with data collection finalised by March 2020.

Strengths and limitations of this study
 This is the first study to trial the effectiveness of a computerised cognitive intervention in maximising fluid intelligence in children with cerebral palsy.
 It is the first randomised controlled trial of a computerised cognitive intervention based on relational frame theory for children with a developmental disability.
 Interventions for cognitive impairment in this population are not readily available, and if effective, this intervention would provide a cost-effective, easily accessible intervention.
 All participants will receive access to the computerised cognitive training intervention prior to the end of the study.
 No active control group is included in this study; therefore we cannot determine impact of the intervention independent of potential placebo or expectancy effects arising from focused use of a computer program.

Introduction
Cerebral palsy (CP), with a prevalence of 1.4 per 1000 live births, 1 is the most common cause of physical disability in children and an estimated 600-700 infants are born with CP in Australia each year. 2 While CP is typically associated with motor impairments, research is now focusing on accompanying cognitive and executive functioning (EF) deficits and how that the development of language and complex reasoning in humans rests upon our ability derive relations between stimuli arbitrarily and without direct experience. An online program designed to train relational framing ability and potentially improve complex reasoning would be a cost-effective, accessible intervention for children with CP.

Cerebral palsy and cognitive impairment
Cerebral palsy refers to a group of motor disorders, originating in a non-progressive injury or disturbance to the brain. [18][19][20] These disturbances occur early in development, impacting the foetal or infant brain. 19 Cerebral palsy is associated with various types of brain lesions, 21 arising from many different causes, congenital and acquired, including intracranial haemorrhage, asphyxia, prematurity, low birth weight or infection. 22 While motor impairment is a defining feature of CP, more recent definitions acknowledge the frequent comorbidities, such as vision problems, epilepsy, and cognitive and communication difficulties. 22,23 Fewer studies have focused on cognitive impairment in cerebral palsy than on motor impairment, but the research that has been undertaken suggests a significant proportion of individuals with CP have impaired cognitive function. 7 A systematic review of rates of impairment in CP found that 49% of children with CP had an intellectual disability, defined as an IQ below 70, while 28% had a severe intellectual disability, with an IQ below 50. 21 Similarly, a population-based study of more than 1,100 individuals with CP in Australia found 45% had been recorded as having an intellectual disability, although level of impairment could not be determined for many in this sample. 7 It is recognised that although CP is a non-progressive disease, the impact of these additional impairments can exert significant influence over a child's development, impacting academic and vocational outcomes, psychological well-being and quality of life, 21

Fluid Intelligence
Amongst most intelligence researchers, there is broad agreement that intelligence is associated with certain abilities, such as problem solving, understanding abstract ideas, or capacity for learning. [24][25][26] One prominent contemporary model, and the most influential at present in the field of intelligence testing, is the Cattell-Horn-Carroll (CHC) theory of intelligence. 27, 28 CHC theory offers a system for classifying cognitive ability that has allowed greater consensus in the literature around what is being measured and referred to by terms such as crystallised and fluid intelligence. 28 Fluid intelligence is a measure of the capacity to solve novel problems and reason abstractly, while crystallised intelligence is a measure of comprehension and acquired knowledge. 29 While in the past, intelligence was considered a stable attribute, more recently, it has been conceptualised as a quality open to change and development. 30 As a result, attention has turned to potential factors that could play a role in determining intelligence, with the aim of developing interventions. 31 Furthermore, by combining technological innovation with proposed models of cognitive plasticity, the possibility of accessible interventions, delivered via computers, iPads or similar devices, has emerged. 14 For example, Løhaugen et al. 32 have proposed a randomised controlled trial assessing the efficacy of computer-based working memory training in children with cerebral palsy.
Various online cognitive training programs have been developed and many of these have targeted working memory (WM), an executive function that involves the ability to temporarily hold and manipulate information. Some researchers have hypothesised that gains in WM could transfer into gains in fluid intelligence. 33,34 Research into this area is ongoing, and results are mixed. 33 While Jaeggi et al. 34 generated great interest in cognitive  36 and research continues in this field.

SMART program
The novel online cognitive training program to be trialled, Strengthening Mental Abilities through Relational Training (SMART), shows promise in pilot studies in helping improve children's cognitive skills (e.g., ability to learn, think, and reason). 17 SMART is a web-based cognitive training program, currently available in English or Dutch, that directly trains the relational abilities thought to be foundational to complex cognition. SMART is grounded in contextual behavioural science, specifically Relational Frame Theory, 17 which proposes that all human language and complex cognition is underpinned by our ability to relate stimuli arbitrarily. That is, humans can relate stimuli in a manner that does not correspond to the physical properties of the stimuli. Such relations between stimuli are called relational frames, and a number of such frames exist, such as coordination (e.g., same as), comparative (e.g., more/less), and temporal frames (e.g., before and after). 37 An example of a relational frame of more/less would be with Australian one-and two-dollar coins, where individuals learn that the two-dollar coin is worth more, even though it is physically smaller than the one-dollar coin.
Many relational frames, including spatial (e.g. under), measurement (e.g. bigger) and ordinal (e.g. first) are foundational to mathematics. 38 Repeated exposure to spatial, measurement, ordinal and other mathematics-relevant relational frames is considered a critical part of early education, helping students develop their understanding of mathematical concepts. 38 In addition to learning relational frames, people can also learn behavioural responses through derived relations, not merely through direct experience. 17 Through derived relations, our relational framing abilities greatly enhance our capacity to learn and to interact effectively with others and our environment. As an example, a person might learn that the star Vega is closer to Earth than Canopus, but further than Sirius. They could then derive that Canopus is the furthest star from Earth of the three, even though it has not been directly taught, and Canopus appears brighter than Vega. As relational framing is foundational to complex cognition, the direct training of relational framing itself has the potential to have widereaching effects on cognition.
The A feasibility pilot study of SMART was conducted over a 9-month period with eight children aged 11-12 years old who had been experiencing educational difficulties at school. 17 Seven of the eight children showed significant increases in their intellectual functioning (as measured by the Wechsler Intelligence Scale for Children -Fourth Edition), an improvement of more than one standard deviation. A 2016 study found similar significant increases in IQ, with a sample size of 15 11-to 12-year-old children. 31 While promising, practice effects need to be accounted for when repeated administration of standardised measures of intelligence occurs, as they may influence performance, with average gains of 6-7 points over a one-month period found for the WISC-V measure of full-scale IQ 39 . Furthermore, assessment of fluid reasoning ability may be more affected by practice effects than verbal or working memory tasks 39 , as fluid reasoning tasks are associated with ability to solve novel problems. A randomised controlled design rather than pre-and post-intervention studies could control for practice effects, but the two studies that have utilised this design have been limited by small sample sizes and high attrition rates. 40,41 To date, no studies have investigated the efficacy of SMART in the cerebral palsy population.
The underlying cognitive skills trained in the program are required for vocabulary acquisition, mathematical reasoning, and other academic and learning skills. The program can be accessed in the client's home at their convenience via iPad, Mac or PC with Internet access and can be completed at the child's own pace. As such, it is a potentially cost-effective solution that can be delivered to children with CP who are unable to access ongoing rehabilitation services.

Specific Aims
The aim of this randomised controlled trial is to test the efficacy of a novel web-based cognitive rehabilitation program for children aged between 8 and 12 years old with mild to moderate congenital CP.

Hypotheses
The primary hypothesis to be tested is that in a randomised controlled trial for children aged 8-12 with CP: 1. Participants in the intervention group will demonstrate improved on a standardised test of intellectual ability performance immediately post-intervention when compared to a waitlist control group receiving care as usual. (Wechsler Intelligence Scale for Children -Fifth Edition; WISC-V) 42,43 The secondary hypotheses to be tested are that the SMART intervention group will demonstrate improvements in the following outcomes:  50 .

Study Design
The study is a randomised controlled trial design with waitlist control group, to determine the effectiveness of the SMART program for children with CP aged 8-12 years (see CONSORT flowchart in Figure 1.) After baseline assessment, participants will be randomly allocated to either the intervention or waitlist control group.
Outcomes will be assessed for all participants at three timepoints, baseline, at 20 weeks postbaseline, and at 40 weeks post-baseline. The intervention group will commence the SMART program immediately and complete it over the following 20 weeks, before undergoing postintervention assessment at 20 weeks post-baseline and follow-up assessment at 40 weeks post-baseline. Participants will be provided with log-in details enabling them to access to the online program at no cost via the program website (http://raiseyouriq.com/) for up to five months. They will be able to access it at home via either iPad or computer. The waitlist control group will continue care as usual for 20 weeks before returning for a second assessment visit, at which point they will commence the SMART program. Final assessment for the waitlist control group will be post-intervention at 40 weeks.
Participants: We aim to recruit 60 children with mild to moderate CP (Gross Motor Function Classification Scale -GMFCS I -IV) aged between 8 and 12 years old. All children are required to have sufficient cooperation and cognitive understanding to perform the tasks and access the novel online cognitive training program, have access to the internet at home, and be able to attend three assessment sessions in Brisbane. Sufficient cooperation and cognitive understanding will be confirmed at baseline assessment, as participants who are able to undertake the iPad-based assessments will be deemed to meet criteria. Children will be excluded if they have unstable epilepsy (i.e., not controlled by medication); an unstable brain injury (e.g., degenerative or metabolic condition); and/or active medical condition (e.g., chemotherapy, radiotherapy, or neurosurgical).
Recruitment: Participants will be recruited from a consent-based research database at the

Queensland Cerebral Palsy and Rehabilitation Research Centre, and through the Queensland
Paediatric Rehabilitation Service at the Queensland Children's Hospital. Participants will be enrolled in the study by the first author.

Patient and public involvement
Participants, families and the public were not involved in the design or recruitment of this study. Participants are informed of the study burden from the time of initial contact, and are advised of their ability to withdraw from the study at any time. All participants will receive feedback on the results of the assessments administered once they have completed their involvement in the study.

Randomisation
Baseline assessments and demographic questionnaires will be completed prior to randomisation. Once complete, participants will be randomised to either waitlist control or intervention group. Randomisation will be via stratified random blocks, using a computergenerated block randomisation sequence, stored by staff members unconnected with the study. Allocation to either waitlist control or intervention will be recorded on pieces of paper, and these will be folded, then placed inside opaque envelopes by a staff member not involved in the study. Envelopes will be sealed, and only opened upon completion of baseline assessment. Participants will be stratified according to IQ (<70 or ≥70), as measured on baseline assessment.

Blinding
Given the nature of the intervention, participants will not be blinded as to which group they are assigned to. As assessment will be undertaken by the first author as part of a PhD project, assessors will not be blinded in this project.

Adverse events
No health or safety risks associated with participation in this study have been identified, and the risk of adverse events is considered low. Any events associated with either intervention or wait-list control groups over the course of the study will be recorded. If any adverse events are identified, they will be reviewed by the investigators. As the ethical review process and trial conduct is overseen by two ethics committees, no additional data monitoring is considered necessary.

Data Management
Participants will be allocated randomly generated identification codes, and these will be used to de-identify hardcopy and electronic files. Paper copies relating to assessment will be deidentified and physically stored in a locked filing cabinet at the Queensland Cerebral Palsy and Rehabilitation Research Centre. Electronic data will be stored on REDCap, a secure web platform for creating and managing online databases. The installation of REDCap used for this project is hosted bv the University of Queensland and managed by the Queensland Clinical Trials and Biostatistics Centre. whether any additional teaching support is accessed, along with parent education and household income.

Measures:
All children will undergo a comprehensive cognitive, psychoeducational, and psychosocial assessment by a psychologist at baseline (i.e., before treatment), and re-assessment at 20 weeks (after intervention for immediate group), and 40 weeks (retention for immediate group, and after intervention for control group). It is noted that many of these assessments have not been validated for children with cerebral palsy, and have been chosen as no valid alternatives are available. However a review of assessments for children with cerebral palsy found that motor involvement, communication and visual impairment were key factors in determining suitability of assessments. 51 We have specifically chosen an iPad-based assessment delivery format for our primary outcome (full-scale IQ), that is similar in motor and language demand to the intervention program itself. If children are able to meet the inclusion criteria for the study, it is anticipated that they will also be able to complete the assessments.
Children will complete the following assessments:  46 The SDQ produces five subscales: emotional symptoms, conduct problems, inattention/hyperactivity, peer problems and prosocial behaviour (range 0-10), and a total difficulties score (range 0-40). Research suggest that for younger children, internal consistency is acceptable for the total difficulties, emotional symptoms, prosocial behaviour, and inattention/hyperactivity subscales, but not for peer and conduct problems. 52 However, Muris et al. 52 note that the scale can provide useful information about psychopathology in children from eight years old.
Parents will also be administered questionnaires during the three assessments points. These include: The SMART program provides an internal measure of Relational Ability, and all children will complete this measure at baseline, 20 weeks and 40 weeks. In addition, information will be recorded on time taken for each participant to complete the program. Assessments at baseline, 20 and 40 weeks will take approximately two to three hours per session. The waitlist control design ensures all children in the study will receive the intervention within six months of being randomised to either commence the program immediately or after 20 weeks.

Qualitative Interview
At the conclusion of the study, semi-structured interviews will be conducted with children and caregivers by the first author, a registered psychologist. The aim of the interview is to explore participants' engagement with the online cognitive rehabilitation program and gain qualitative insights into families' experience with the program. Questions will cover what families like and disliked about the program, how easy they found it was to access at home, and to remain engaged. If the program is found to be effective, such qualitative insights will  psychologist will regularly contact the family and monitor that child's progress, supporting both parent and child in meeting their goals for SMART, and maintaining engagement.
A resource guide prepared for this study will be provided to all families. This guide provides technical information on accessing the program, a description of how to work through each stage of the program, and information on how parents can support their child to work on the program, including a visual chart to keep track of progress.
Statistical Analysis: Study hypotheses will be analysed by means of appropriate statistical tests, with statistical significance for all tests set at p<0.05 with adjustment for multiple comparisons, and all analyses will be intention to treat. We propose to carry out a Benjamini-Hochberg procedure to control for false discoveries. 54 Mixed analysis of covariance analyses will be conducted with time (baseline and 20 weeks) as the within subjects variable, and group (intervention or waitlist) as the between subjects variable, and baseline data as the covariate. Secondary analysis will profile cognitive change over time for participants based on their test scores. This will include t tests and linear regression to explore within-subject differences from post-intervention to follow-up, and over three timepoints (baseline, post-intervention and follow-up) for participants in the intervention group.

Power Analysis and Sample Size:
Power analysis was conducted using the software package G*Power 55 , for an ANCOVA repeated measures, between factors test. With a sample size of 60 subjects, and assuming an error rate of 5% and p=0.70 for within-subject correlations, this sample size results in 81.37% power to detect a large (Cohen's f=0.40) mean difference of 12 IQ points between groups, after allowing for an attrition rate of 10%.

Ethics and Dissemination
This study has received full ethical approval from the Children's Health Queensland Hospital and Health Service Research Ethics Committee (HREC/14/QRCH/377) and The University of Queensland (2017001806). Protocol modifications and amendments will be submitted to the ethics committees for approval. Amendments to the protocol will be included in publications reporting on outcomes of this study. All families will be provided with a written informed consent form by the first author at the initial visit (Supplementary Appendix B) that they will be required to sign before commencing participation. This trial has been registered with the Australian New Zealand Clinical Trials Registry, Trial ID: ACTRN12617001550392. Study results will be disseminated through publication in scientific journals and participation in conferences. The authors of this protocol will be authors of any publications describing study outcomes, and professional writers will not be used. Families who participate in the study will receive information on the study results, as well as a feedback report on the outcomes of assessments their child has completed. If the computerised cognitive training program is found to be effective, dissemination of these

Trial Progress
This protocol is Version 2, 16 March 2019. The study is currently actively recruiting participants, after initial recruitment commenced in June 2018.

Discussion
This protocol paper has reported the background and study design for a randomised controlled trial investigating the effectiveness of a computerised cognitive training program for children with CP. This program has not previously been studied in this population. The research study will assess children's cognitive skills, executive ability and social and emotional functioning, with fluid intelligence the primary outcome of interest. Qualitative information will be gathered on families' experience engaging with the program. Results of the study will be disseminated through peer-reviewed journals and at relevant scientific conferences.
Nearly half of all children with CP are estimated to also have an intellectual impairment, impacting academic achievement and ability to achieve educational and vocational goals in the long-term. If this computerised cognitive training program is found to be effective, a flexible, easily accessible intervention will be available for this population, where at present there at few options available for addressing difficulties with cognitive skills in CP.

Contributors
The study was designed and established by all the authors. JW is responsible for the ethics application and reporting. JW is responsible for recruitment and data collection. JW will take a lead role in preparing publications on the clinical outcomes of the study. KW, RB and JS Scholarship.

Competing Interests
The authors state they have no competing interests in this project.      Thank you for taking part in the SMART study. This study has been conducted as part of PhD project through the Queensland Cerebral Palsy and Rehabilitation Research Centre. The study's aim was to independently test the SMART intervention that was originally developed by educational psychologists in Ireland at Maynooth University and determine whether it is effective for children with cerebral palsy.
I would like to ask you about your involvement with SMART to learn more about how other families might engage with the program.
Would it be possible to audio record our conversation so I can prepare an accurate transcript of the discussion?
The recording will be transcribed and stored securely, using your study ID rather than name, to maintain confidentiality.  Time schedule of enrolment, interventions (including any run-ins and washouts), assessments, and visits for participants. A schematic diagram is highly recommended (see Figure) Flow Chart Figure 1

(CONSORT Flow chart)
Sample size 14 Estimated number of participants needed to achieve study objectives and how it was determined, including clinical and statistical assumptions supporting any sample size calculations Page 18-19

Recruitment 15
Strategies for achieving adequate participant enrolment to reach target sample size Page 11.

Methods: Assignment of interventions (for controlled trials)
Allocation: Sequence generation 16a Method of generating the allocation sequence (eg, computergenerated random numbers), and list of any factors for stratification.
To reduce predictability of a random sequence, details of any planned restriction (eg, blocking) should be provided in a separate document that is unavailable to those who enrol participants or assign interventions Page 11 Allocation concealment mechanism 16b Mechanism of implementing the allocation sequence (eg, central telephone; sequentially numbered, opaque, sealed envelopes), describing any steps to conceal the sequence until interventions are assigned Page 11 Implementation 16c Who will generate the allocation sequence, who will enrol participants, and who will assign participants to interventions Page 11-12 Blinding (masking) 17a Who will be blinded after assignment to interventions (eg, trial participants, care providers, outcome assessors, data analysts), and how Page 12 (no blinding) 20c Definition of analysis population relating to protocol non-adherence (eg, as randomised analysis), and any statistical methods to handle missing data (eg, multiple imputation) Page 18

Methods: Monitoring
Data monitoring 21a Composition of data monitoring committee (DMC); summary of its role and reporting structure; statement of whether it is independent from the sponsor and competing interests; and reference to where further details about its charter can be found, if not in the protocol. Alternatively, an explanation of why a DMC is not needed Page 12 Consent or assent 26a Who will obtain informed consent or assent from potential trial participants or authorised surrogates, and how (see Item 32) Page 19 26b Additional consent provisions for collection and use of participant data and biological specimens in ancillary studies, if applicable NA

Confidentiality 27
How personal information about potential and enrolled participants will be collected, shared, and maintained in order to protect confidentiality before, during, and after the trial Page 12

Declaration of interests 28
Financial and other competing interests for principal investigators for the overall trial and each study site Page 21 Access to data 29 Statement of who will have access to the final trial dataset, and disclosure of contractual agreements that limit such access for investigators Page 20

Methods and Analysis
Sixty children with mild to moderate CP (Gross Motor Function Classification Scale -GMFCS I -IV) aged between 8 and 12 will be recruited. Participants will be randomly allocated to two groups: SMART cognitive training and waitlist control. Families will access the program at home over a four-month period. Assessments will be administered at baseline, 20 weeks and at 40-week follow-up for retention. The primary outcome will be fluid intelligence, while academic achievement, executive function and social and emotional wellbeing will be secondary outcomes.

Ethics and Dissemination
This study has approval from the Children's Health Queensland Hospital and Health Service Research Ethics Committee (HREC/14/QRCH/377) and The University of Queensland (2017001806). If the computerised cognitive training program is found to be effective, dissemination of these findings would assist children with CP by providing an accessible, cost-effective intervention that can be completed at home at the individual's own pace.

Registration Details
This trial is registered with the Australian New Zealand Clinical Trials Registry, Trial ID: ACTRN12617001550392. The study was registered prospectively on 10 November 2017 to present. Recruitment is now under way and we aim to complete recruitment by June 2019, with data collection finalised by March 2020.

Strengths and limitations of this study
 This is the first study to trial the effectiveness of a computerised cognitive intervention in maximising fluid intelligence in children with cerebral palsy.
 It is the first randomised controlled trial of a computerised cognitive intervention based on relational frame theory for children with a developmental disability.
 Interventions for cognitive impairment in this population are not readily available, and if effective, this intervention would provide a cost-effective, easily accessible intervention.
 All participants will receive access to the computerised cognitive training intervention prior to the end of the study.
 No active control group is included in this study; therefore we cannot determine impact of the intervention independent of potential placebo or expectancy effects arising from focused use of a computer program.

Introduction
Cerebral palsy (CP), with a prevalence of 1.4 per 1000 live births, 1 is the most common cause of physical disability in children and an estimated 600-700 infants are born with CP in Australia each year. 2 While CP is typically associated with motor impairments, research is now focusing on accompanying cognitive and executive functioning (EF) deficits and how independently. [8][9][10][11] While there is growing awareness of cognitive and EF limitations, interventions for CP are typically associated with improving physical activity, limb function, and participation in daily living activities. 12 Few interventions target cognitive function and academic abilities. 12,13 A review looking at new technologies in the treatment of CP and developmental coordination disorder found no studies investigating specific cognitive interventions in these groups. 14   that the development of language and complex reasoning in humans rests upon our ability derive relations between stimuli arbitrarily and without direct experience. An online program designed to train relational framing ability and potentially improve complex reasoning would be a cost-effective, accessible intervention for children with CP.

Cerebral palsy and cognitive impairment
Cerebral palsy refers to a group of motor disorders, originating in a non-progressive injury or disturbance to the brain. [18][19][20] These disturbances occur early in development, impacting the foetal or infant brain. 19 Cerebral palsy is associated with various types of brain lesions, 21 arising from many different causes, congenital and acquired, including intracranial haemorrhage, asphyxia, prematurity, low birth weight or infection. 22 While motor impairment is a defining feature of CP, more recent definitions acknowledge the frequent comorbidities, such as vision problems, epilepsy, and cognitive and communication difficulties. 22,23 Fewer studies have focused on cognitive impairment in cerebral palsy than on motor impairment, but the research that has been undertaken suggests a significant proportion of individuals with CP have impaired cognitive function. 7 A systematic review of rates of impairment in CP found that 49% of children with CP had an intellectual disability, defined as an IQ below 70, while 28% had a severe intellectual disability, with an IQ below 50. 21 Similarly, a population-based study of more than 1,100 individuals with CP in Australia found 45% had been recorded as having an intellectual disability, although level of impairment could not be determined for many in this sample. 7 It is recognised that although CP is a non-progressive disease, the impact of these additional impairments can exert significant influence over a child's development, impacting academic and vocational outcomes, psychological well-being and quality of life, 21 as well as general health. 7  1  2  3  4  5  6  7  8  9  10  11  12  13  14  15  16  17  18  19  20  21  22  23  24  25  26  27  28  29  30  31  32  33  34  35  36  37  38  39  40  41  42  43  44  45  46  47  48  49  50  51  52  53  54  55  56  57  58  59

Fluid Intelligence
Amongst most intelligence researchers, there is broad agreement that intelligence is associated with certain abilities, such as problem solving, understanding abstract ideas, or capacity for learning. [24][25][26] One prominent contemporary model, and the most influential at present in the field of intelligence testing, is the Cattell-Horn-Carroll (CHC) theory of intelligence. 27, 28 CHC theory offers a system for classifying cognitive ability that has allowed greater consensus in the literature around what is being measured and referred to by terms such as crystallised and fluid intelligence. 28 Fluid intelligence is a measure of the capacity to solve novel problems and reason abstractly, while crystallised intelligence is a measure of comprehension and acquired knowledge. 29 While in the past, intelligence was considered a stable attribute, more recently, it has been conceptualised as a quality open to change and development. 30 As a result, attention has turned to potential factors that could play a role in determining intelligence, with the aim of developing interventions. 31 Furthermore, by combining technological innovation with proposed models of cognitive plasticity, the possibility of accessible interventions, delivered via computers, iPads or similar devices, has emerged. 14 For example, Løhaugen et al. 32 have proposed a randomised controlled trial assessing the efficacy of computer-based working memory training in children with cerebral palsy.
Various online cognitive training programs have been developed and many of these have targeted working memory (WM), an executive function that involves the ability to temporarily hold and manipulate information. Some researchers have hypothesised that gains in WM could transfer into gains in fluid intelligence. 33,34 Research into this area is ongoing, and results are mixed. 33 While Jaeggi et al. 34 generated great interest in cognitive  1  2  3  4  5  6  7  8  9  10  11  12  13  14  15  16  17  18  19  20  21  22  23  24  25  26  27  28  29  30  31  32  33  34  35  36  37  38  39  40  41  42  43  44  45  46  47  48  49  50  51  52  53  54  55  56  57  58  59  60   F  o  r  p  e  e  r  r  e  v  i  e  w  o  n  l  y   7 training when they reported gains in fluid intelligence after WM training, 35 numerous studies have failed to replicate such transfer effects, 36 and research continues in this field.

SMART program
The novel online cognitive training program to be trialled, Strengthening Mental Abilities through Relational Training (SMART), shows promise in pilot studies in helping improve children's cognitive skills (e.g., ability to learn, think, and reason). 17 SMART is a web-based cognitive training program, currently available in English or Dutch, that directly trains the relational abilities thought to be foundational to complex cognition. SMART is grounded in contextual behavioural science, specifically Relational Frame Theory, 17 which proposes that all human language and complex cognition is underpinned by our ability to relate stimuli arbitrarily. That is, humans can relate stimuli in a manner that does not correspond to the physical properties of the stimuli. Such relations between stimuli are called relational frames, and a number of such frames exist, such as coordination (e.g., same as), comparative (e.g., more/less), and temporal frames (e.g., before and after). 37 An example of a relational frame of more/less would be with Australian one-and two-dollar coins, where individuals learn that the two-dollar coin is worth more, even though it is physically smaller than the one-dollar coin.
Many relational frames, including spatial (e.g. under), measurement (e.g. bigger) and ordinal (e.g. first) are foundational to mathematics. 38 Repeated exposure to spatial, measurement, ordinal and other mathematics-relevant relational frames is considered a critical part of early education, helping students develop their understanding of mathematical concepts. 38 In addition to learning relational frames, people can also learn behavioural responses through derived relations, not merely through direct experience. 17 Through derived relations, our relational framing abilities greatly enhance our capacity to learn and to interact effectively with others and our environment. As an example, a person might learn that the star Vega is  1  2  3  4  5  6  7  8  9  10  11  12  13  14  15  16  17  18  19  20  21  22  23  24  25  26  27  28  29  30  31  32  33  34  35  36  37  38  39  40  41  42  43  44  45  46  47  48  49  50  51  52  53  54  55  56  57  58  59  60   F  o  r  p  e  e  r  r  e  v  i  e  w  o  n  l  y   8 closer to Earth than Canopus, but further than Sirius. They could then derive that Canopus is the furthest star from Earth of the three, even though it has not been directly taught, and Canopus appears brighter than Vega. As relational framing is foundational to complex cognition, the direct training of relational framing itself has the potential to have widereaching effects on cognition.
The A feasibility pilot study of SMART was conducted over a 9-month period with eight children aged 11-12 years old who had been experiencing educational difficulties at school. 17 Seven of the eight children showed significant increases in their intellectual functioning (as measured by the Wechsler Intelligence Scale for Children -Fourth Edition), an improvement of more than one standard deviation. A 2016 study found similar significant increases in IQ, with a sample size of 15 11-to 12-year-old children. 31 While promising, practice effects need to be accounted for when repeated administration of standardised measures of intelligence occurs, as they may influence performance, with average gains of 6-7 points over a one-month period found for the WISC-V measure of full-scale IQ 39 . Furthermore, assessment of fluid reasoning ability may be more affected by practice effects than verbal or working memory

Specific Aims
The aim of this randomised controlled trial is to test the efficacy of a novel web-based cognitive rehabilitation program for children aged between 8 and 12 years old with mild to moderate congenital CP.

Study Design
The study is a randomised controlled trial design with waitlist control group, to determine the effectiveness of the SMART program for children with CP aged 8-12 years (see CONSORT flowchart in Figure 1.) After baseline assessment, participants will be randomly allocated to either the intervention or waitlist control group.
Outcomes will be assessed for all participants at three timepoints, baseline, at 20 weeks postbaseline, and at 40 weeks post-baseline. The intervention group will commence the SMART program immediately and complete it over the following 20 weeks, before undergoing postintervention assessment at 20 weeks post-baseline and follow-up assessment at 40 weeks post-baseline. Participants will be provided with log-in details enabling them to access to the online program at no cost via the program website (http://raiseyouriq.com/) for up to five months. They will be able to access it at home via either iPad or computer. The waitlist control group will continue care as usual for 20 weeks before returning for a second assessment visit, at which point they will commence the SMART program. Final assessment for the waitlist control group will be post-intervention at 40 weeks.
Participants: We aim to recruit 60 children with mild to moderate CP (Gross Motor Function Classification Scale -GMFCS I -IV) aged between 8 and 12 years old. All children are  1  2  3  4  5  6  7  8  9  10  11  12  13  14  15  16  17  18  19  20  21  22  23  24  25  26  27  28  29  30  31  32  33  34  35  36  37  38  39  40  41  42  43  44  45  46  47  48  49  50  51  52  53  54  55  56  57  58  59  60   F  o  r  p  e  e  r  r  e  v  i  e  w  o  n  l  y   11   required to have sufficient cooperation and cognitive understanding to perform the tasks and   access the novel online cognitive training program, have access to the internet at home, and be able to attend three assessment sessions in Brisbane. Sufficient cooperation and cognitive understanding will be confirmed at baseline assessment, as participants who are able to undertake the iPad-based assessments will be deemed to meet criteria. Children will be excluded if they have unstable epilepsy (i.e., not controlled by medication); an unstable brain injury (e.g., degenerative or metabolic condition); and/or active medical condition (e.g., chemotherapy, radiotherapy, or neurosurgical).
Recruitment: Participants will be recruited from a consent-based research database at the

Queensland Cerebral Palsy and Rehabilitation Research Centre, and through the Queensland
Paediatric Rehabilitation Service at the Queensland Children's Hospital. Participants will be enrolled in the study by the first author.

Patient and public involvement
Participants, families and the public were not involved in the design or recruitment of this study. Participants are informed of the study burden from the time of initial contact, and are advised of their ability to withdraw from the study at any time. All participants will receive feedback on the results of the assessments administered once they have completed their involvement in the study.

Randomisation
Baseline assessments and demographic questionnaires will be completed prior to randomisation. Once complete, participants will be randomised to either waitlist control or intervention group. Randomisation will be via stratified random blocks, using a computergenerated block randomisation sequence, stored by staff members unconnected with the study. Allocation to either waitlist control or intervention will be recorded on pieces of paper, and these will be folded, then placed inside opaque envelopes by a staff member not involved in the study. Envelopes will be sealed, and only opened upon completion of baseline assessment. Participants will be stratified according to IQ (<70 or ≥70), as measured on baseline assessment.

Blinding
Given the nature of the intervention, participants will not be blinded as to which group they are assigned to. As assessment will be undertaken by the first author as part of a PhD project, assessors will not be blinded in this project.

Adverse events
No health or safety risks associated with participation in this study have been identified, and the risk of adverse events is considered low. Any events associated with either intervention or wait-list control groups over the course of the study will be recorded. All participants allocated to the wait-list control group receive access to the intervention after the second assessment. This ensures no adverse impacts through omission of intervention in the event that the intervention is found to be efficacious. If any adverse events are identified, they will be reviewed by the investigators. As the ethical review process and trial conduct is overseen by two ethics committees, no additional data monitoring is considered necessary.

Data Management
Participants will be allocated randomly generated identification codes, and these will be used to de-identify hardcopy and electronic files. Paper copies relating to assessment will be de-

Measures:
Demographic information will be obtained via a parent survey, gathering information on the participant's background, including gestational age, comorbid diagnoses, and GMFCS classification. Further demographic information includes school year, type of school, and whether any additional teaching support is accessed, along with parent education and household income.
All children will undergo a comprehensive cognitive, psychoeducational, and psychosocial assessment by a psychologist at baseline (i.e., before treatment), and re-assessment at 20 weeks (after intervention for immediate group), and 40 weeks (retention for immediate group, and after intervention for control group). It is noted that many of these assessments have not been validated for children with cerebral palsy, and have been chosen as no valid alternatives are available. However a review of assessments for children with cerebral palsy found that motor involvement, communication and visual impairment were key factors in determining suitability of assessments. 51 We have specifically chosen an iPad-based assessment delivery format for our primary outcome (full-scale IQ), that is similar in motor and language demand to the intervention program itself. If children are able to meet the inclusion criteria for the study, it is anticipated that they will also be able to complete the assessments.
Children will complete the following assessments:  46 The SDQ produces five subscales: emotional symptoms, conduct problems, inattention/hyperactivity, peer problems and prosocial behaviour (range 0-10), and a total difficulties score (range 0-40). Research suggest that for younger children, internal consistency is acceptable for the total difficulties, emotional symptoms, prosocial behaviour, and inattention/hyperactivity subscales, but not for peer and conduct problems. 52 However, Muris et al. 52 note that the scale can provide useful information about psychopathology in children from eight years old.
Parents will also be administered questionnaires during the three assessments points. These include: The SMART program provides an internal measure of Relational Ability, and all children will complete this measure at baseline, 20 weeks and 40 weeks. In addition, information will be recorded on time taken for each participant to complete the program. Assessments at baseline, 20 and 40 weeks will take approximately two to three hours per session. The waitlist control design ensures all children in the study will receive the intervention within six months of being randomised to either commence the program immediately or after 20 weeks.

Qualitative Interview
At the conclusion of the study, semi-structured interviews will be conducted with children and caregivers by the first author, a registered psychologist. The aim of the interview is to explore participants' engagement with the online cognitive rehabilitation program and gain qualitative insights into families' experience with the program. Questions will cover what families like and disliked about the program, how easy they found it was to access at home, and to remain engaged. If the program is found to be effective, such qualitative insights will  psychologist will regularly contact the family and monitor that child's progress, supporting both parent and child in meeting their goals for SMART, and maintaining engagement.
A resource guide prepared for this study will be provided to all families. This guide provides technical information on accessing the program, a description of how to work through each stage of the program, and information on how parents can support their child to work on the program, including a visual chart to keep track of progress.
Statistical Analysis: Study hypotheses will be analysed by means of appropriate statistical tests, with statistical significance for all tests set at p<0.05 with adjustment for multiple comparisons, and all analyses will be intention to treat. We propose to carry out a Benjamini-Hochberg procedure to control for false discoveries. 54 Mixed analysis of covariance analyses will be conducted with time (baseline and 20 weeks) as the within subjects variable, and group (intervention or waitlist) as the between subjects variable, and baseline data as the covariate. Secondary analysis will profile cognitive change over time for participants based on their test scores. This will include t tests and linear  1  2  3  4  5  6  7  8  9  10  11  12  13  14  15  16  17  18  19  20  21  22  23  24  25  26  27  28  29  30  31  32  33  34  35  36  37  38  39  40  41  42  43  44  45  46  47  48  49  50  51  52  53  54  55  56  57  58  59  60   F  o  r  p  e  e  r  r  e  v  i  e  w  o  n  l  y   19 regression to explore within-subject differences from post-intervention to follow-up, and over three timepoints (baseline, post-intervention and follow-up) for participants in the intervention group.

Power Analysis and Sample Size:
Power analysis was conducted using the software package G*Power 55 , for an ANCOVA repeated measures, between factors test. With a sample size of 60 subjects, and assuming an error rate of 5% and p=0.70 for within-subject correlations, this sample size results in 81.37% power to detect a large (Cohen's f=0.40) mean difference of 12 IQ points between groups, after allowing for an attrition rate of 10%.

Ethics and Dissemination
This study has received full ethical approval from the Children's Health Queensland Hospital and Health Service Research Ethics Committee (HREC/14/QRCH/377) and The University of Queensland (2017001806). Protocol modifications and amendments will be submitted to the ethics committees for approval. Amendments to the protocol will be included in publications reporting on outcomes of this study. All families will be provided with a written informed consent form by the first author at the initial visit (Supplementary Appendix B) that they will be required to sign before commencing participation. This trial has been registered with the Australian New Zealand Clinical Trials Registry, Trial ID: ACTRN12617001550392. Study results will be disseminated through publication in scientific journals and participation in conferences. The authors of this protocol will be authors of any publications describing study outcomes, and professional writers will not be used. Families who participate in the study will receive information on the study results, as well as a feedback report on the outcomes of assessments their child has completed. If the computerised cognitive training program is found to be effective, dissemination of these  1  2  3  4  5  6  7  8  9  10  11  12  13  14  15  16  17  18  19  20  21  22  23  24  25  26  27  28  29  30  31  32  33  34  35  36  37  38  39  40  41  42  43  44  45  46  47  48  49  50  51  52  53  54  55  56  57  58  59  60   F  o  r  p  e  e  r  r  e  v  i  e  w  o  n  l  y   20 findings would assist children with CP by providing an easily accessible, cost-effective intervention that can be completed at home at the individual's own pace.

Trial Progress
This protocol is Version 3, 10 May 2019. The study is currently actively recruiting participants, after initial recruitment commenced in June 2018.

Discussion
This protocol paper has reported the background and study design for a randomised controlled trial investigating the effectiveness of a computerised cognitive training program for children with CP. This program has not previously been studied in this population. The research study will assess children's cognitive skills, executive ability and social and emotional functioning, with fluid intelligence the primary outcome of interest. Qualitative information will be gathered on families' experience engaging with the program. Results of the study will be disseminated through peer-reviewed journals and at relevant scientific conferences.
Nearly half of all children with CP are estimated to also have an intellectual impairment, impacting academic achievement and ability to achieve educational and vocational goals in the long-term. If this computerised cognitive training program is found to be effective, a flexible, easily accessible intervention will be available for this population, where at present there at few options available for addressing difficulties with cognitive skills in CP.
The recording will be transcribed and stored securely, using your study ID rather than name, to maintain confidentiality.

________________________________________________________________________________
Parent Questions: 1) What did you like best about the SMART program?
Follow-up: Why did you like X the best?
2) What did you like least about the SMART program?
Follow-up: "Why did you not like X?"   1  2  3  4  5  6  7  8  9  10  11  12  13  14  15  16  17  18  19  20  21  22  23  24  25  26  27  28  29  30  31  32  33  34  35  36  37  38  39  40  41  42  43  44  45  46  47  48  49  50  51  52  53  54  55  56  57  58  59 1  2  3  4  5  6  7  8  9  10  11  12  13  14  15  16  17  18  19  20  21  22  23  24  25  26  27  28  29  30  31  32  33  34  35  36  37  38  39  40  41  42  43  44  45  46  47  48  49  50  51  52  53  54  55  56  57  58  59  I have received a Parent/Guardian Information Statement to keep and I believe I understand the purpose, extent and possible effects of my child's involvement I have been asked if I would like to have a family member or friend with me while the project was explained I have had an opportunity to ask questions and I am satisfied with the answers I have received I understand that the researcher has agreed not to reveal results of any information involving my child, subject to legal requirements If information about this project is published or presented in any public form, I understand that the researcher will not reveal my child's identity I understand that if I refuse to consent to my child's participation, or if I withdraw my child from the project at any time without explanation, this will not affect my child's access to the best available treatment options and care from Children's Health Queensland. If you do not wish to participate, it is okay to say no I understand I will receive a copy of this consent form -I consent to participate in this research project.

SIGNATURE Date
I have explained the study to the parent/guardian who has signed above, and believe that they understand the purpose, extent and possible effects of their child's involvement in this study.
RESEARCHER'S SIGNATURE Date Note: All parties signing the Consent Form must date their own signature.  1  2  3  4  5  6  7  8  9  10  11  12  13  14  15  16  17  18  19  20  21  22  23  24  25  26  27  28  29  30  31  32  33  34  35  36  37  38  39  40  41  42  43  44  45  46  47  48  49  50  51  52  53  54  55  56  57  58  59  Roles and responsibilities 5b Name and contact information for the trial sponsor NA, no sponsor 5c Role of study sponsor and funders, if any, in study design; collection, management, analysis, and interpretation of data; writing of the report; and the decision to submit the report for publication, including whether they will have ultimate authority over any of these activities NA 5d Composition, roles, and responsibilities of the coordinating centre, steering committee, endpoint adjudication committee, data management team, and other individuals or groups overseeing the trial, if applicable (see Item 21a for data monitoring committee) NA Trial design 8 Description of trial design including type of trial (eg, parallel group, crossover, factorial, single group), allocation ratio, and framework (eg, superiority, equivalence, noninferiority, exploratory) Page 10

Methods: Participants, interventions, and outcomes
Study setting 9 Description of study settings (eg, community clinic, academic hospital) and list of countries where data will be collected. Reference to where list of study sites can be obtained Page 11 Eligibility criteria 10 Inclusion and exclusion criteria for participants. If applicable, eligibility criteria for study centres and individuals who will perform the interventions (eg, surgeons, psychotherapists) Page 11 11a Interventions for each group with sufficient detail to allow replication, including how and when they will be administered Page 18 11b Criteria for discontinuing or modifying allocated interventions for a given trial participant (eg, drug dose change in response to harms, participant request, or improving/worsening disease) NA 11c Strategies to improve adherence to intervention protocols, and any procedures for monitoring adherence (eg, drug tablet return, laboratory tests)

Page 11
Interventions 11d Relevant concomitant care and interventions that are permitted or prohibited during the trial NA  1  2  3  4  5  6  7  8  9  10  11  12  13  14  15  16  17  18  19  20  21  22  23  24  25  26  27  28  29  30  31  32  33  34  35  36  37  38  39  40  41  42  43  44  45  46  47  48  49  50  51  52  53  54  55  56  57  58  59  60   F  o  r  p  e  e  r  r  e  v  i  e  w  o  n  l  y   3   Outcomes  12 Primary, secondary, and other outcomes, including the specific measurement variable (eg, systolic blood pressure), analysis metric (eg, change from baseline, final value, time to event), method of aggregation (eg, median, proportion), and time point for each outcome. Explanation of the clinical relevance of chosen efficacy and harm outcomes is strongly recommended Page 13 to page 17 Participant timeline 13 Time schedule of enrolment, interventions (including any run-ins and washouts), assessments, and visits for participants. A schematic diagram is highly recommended (see Figure) Flow Chart Figure 1

(CONSORT Flow chart)
Sample size 14 Estimated number of participants needed to achieve study objectives and how it was determined, including clinical and statistical assumptions supporting any sample size calculations Page 18-19

Recruitment 15
Strategies for achieving adequate participant enrolment to reach target sample size Page 11.

Methods: Assignment of interventions (for controlled trials)
Allocation: Sequence generation 16a Method of generating the allocation sequence (eg, computergenerated random numbers), and list of any factors for stratification.
To reduce predictability of a random sequence, details of any planned restriction (eg, blocking) should be provided in a separate document that is unavailable to those who enrol participants or assign interventions Page 11 Allocation concealment mechanism 16b Mechanism of implementing the allocation sequence (eg, central telephone; sequentially numbered, opaque, sealed envelopes), describing any steps to conceal the sequence until interventions are assigned Page 11 Implementation 16c Who will generate the allocation sequence, who will enrol participants, and who will assign participants to interventions Page 11-12 Blinding (masking) 17a Who will be blinded after assignment to interventions (eg, trial participants, care providers, outcome assessors, data analysts), and how Page 12 (no blinding)  1  2  3  4  5  6  7  8  9  10  11  12  13  14  15  16  17  18  19  20  21  22  23  24  25  26  27  28  29  30  31  32  33  34  35  36  37  38  39  40  41  42  43  44  45  46  47  48  49  50  51  52  53  54  55  56  57  58  59  60   F  o  r  p  e  e  r  r  e  v  i  e  w  o  n  l  y   4 17b If blinded, circumstances under which unblinding is permissible, and procedure for revealing a participant's allocated intervention during the trial NA

Methods: Data collection, management, and analysis
Data collection methods 18a Plans for assessment and collection of outcome, baseline, and other trial data, including any related processes to promote data quality (eg, duplicate measurements, training of assessors) and a description of study instruments (eg, questionnaires, laboratory tests) along with their reliability and validity, if known. Reference to where data collection forms can be found, if not in the protocol Page 12, Page 13-17 18b Plans to promote participant retention and complete follow-up, including list of any outcome data to be collected for participants who discontinue or deviate from intervention protocols Page 18 Data management 19 Plans for data entry, coding, security, and storage, including any related processes to promote data quality (eg, double data entry; range checks for data values). Reference to where details of data management procedures can be found, if not in the protocol Page 12 Statistical methods 20a Statistical methods for analysing primary and secondary outcomes. Reference to where other details of the statistical analysis plan can be found, if not in the protocol Page 18 20b Methods for any additional analyses (eg, subgroup and adjusted analyses) Page 18 20c Definition of analysis population relating to protocol non-adherence (eg, as randomised analysis), and any statistical methods to handle missing data (eg, multiple imputation) Page 18

Methods: Monitoring
Data monitoring 21a Composition of data monitoring committee (DMC); summary of its role and reporting structure; statement of whether it is independent from the sponsor and competing interests; and reference to where further details about its charter can be found, if not in the protocol. Alternatively, an explanation of why a DMC is not needed Page 12 21b Description of any interim analyses and stopping guidelines, including who will have access to these interim results and make the final decision to terminate the trial NA

Harms 22
Plans for collecting, assessing, reporting, and managing solicited and spontaneously reported adverse events and other unintended effects of trial interventions or trial conduct Page 12

Auditing 23
Frequency and procedures for auditing trial conduct, if any, and whether the process will be independent from investigators and the sponsor NA

Research ethics approval 24
Plans for seeking research ethics committee/institutional review board (REC/IRB) approval

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Protocol amendments 25 Plans for communicating important protocol modifications (eg, changes to eligibility criteria, outcomes, analyses) to relevant parties (eg, investigators, REC/IRBs, trial participants, trial registries, journals, regulators)

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Consent or assent 26a Who will obtain informed consent or assent from potential trial participants or authorised surrogates, and how (see Item 32) Page 19 26b Additional consent provisions for collection and use of participant data and biological specimens in ancillary studies, if applicable NA

Confidentiality 27
How personal information about potential and enrolled participants will be collected, shared, and maintained in order to protect confidentiality before, during, and after the trial Page 12