Introduction Adolescents with brain injury frequently have difficulties with social competence, which persist into adulthood affecting their participation in daily life. To date, there has been limited research into the efficacy of social competence interventions in this population. Research from the Program for the Education and Enrichment of Relational Skills (PEERS) has demonstrated significant improvements in social competence skills, maintained at 1-year to 5-year follow-up, for adolescents with autism spectrum disorder. PEERS has not yet been tested among adolescents with brain injury. This protocol describes a pragmatic, parallel two-group pre-test post-test randomised waitlist control trial across two sites in Australia, which aims to evaluate the feasibility, acceptability and efficacy of PEERS in adolescents with brain injury compared with usual care.
Methods and analysis Forty adolescents with an acquired brain injury or cerebral palsy will be randomly assigned to either the 14-week PEERS group or waitlist care as usual group. The waitlist group will then receive PEERS following the 26-week retention time point. Outcomes will be assessed at baseline, 14 weeks (immediately postintervention) and 26 weeks follow-up (retention). The primary outcomes are self-report and parent report on the Social Skills Improvement System Rating Scales immediately post PEERS at 14 weeks. Secondary outcomes include increased frequency of get-togethers with peers with reduced conflict and increased adolescent self-reported knowledge of social skills. Acceptability and feasibility will be examined through qualitative analysis of focus group data collected after the completion of each group.
Ethics and dissemination Ethics approval has been granted by the Medical Research Ethics Committee Children’s Health Queensland Hospital and Health Service Human Research Ethics Committee (HREC/17/QRCH/87), The University of Queensland (2017000864) and the Cerebral Palsy Alliance Ethics Committee (20170802/HREC:EC00402). The findings will be disseminated in peer-reviewed journals, by conference presentation and newsletters to consumers.
Trial registration number ACTRN12617000723381.
- developmental neurology & neurodisability
- rehabilitation medicine
- clinical trials
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Author Contributions RG, LS, SMc, HS-S, NH, TW, AMS, KQ and EL conceived the study and defined the original study protocol. LS and SMc are responsible for all ethics applications and the ethical reporting of the study. RG, LS, SMc, HS-S, NH, TW, AMS and EL are responsible for the applications associated with the study. RG, LS, SMc, HS-S, NH, TW and KQ are responsible for recruitment, data collection and implementation of the study. LS and JZ will supervise RG (PhD student) during the trial. MC provided statistical support and managed randomisation and concealed allocation. All authors have read and approved the final manuscript.
Funding This work was supported through a project grant by the Motor Accident Insurance Commission (MAIC) of Queensland and Kids Rehab Trust Fund, The Children’s Hospital at Westmead. The MAIC had no role in the study design, collection of data, writing and submitting this protocol. Kids Rehab Trust Fund at The Children’s Hospital at Westmead provided funding for an additional facilitator for the adolescent group. Staff from Kids Rehab were involved in the study design, collection of data, writing and submitting this protocol. HSS received support through a National Health and Medical Research Council (NHMRC) Early Career Fellowship 1144566 and the Australasian Cerebral Palsy Clinical Trials Network (AusCPCTN). SM received support through an NHMRC Early Career Fellowship 1111270. LS is supported through an NHMRC Career Development Fellowship (1160694), RG is supported by an NHMRC Postgraduate Scholarship (APP1168214), Children’s Hospital Foundation scholarship top-up (50278) and the AusCPCTN. EL is supported by an NIH Autism Center of Excellence Grant (2P50HD055784-11) and the Tarjan Center, University Centers for Excellence in Developmental Disabilities (621587-GE-31303).
Competing interests EL receives book royalties from Taylor & Francis Group and Wiley for the copyrighted PEERS she co-founded.
Patient consent for publication Not required
Ethics approval Full ethical approval has been granted by the Medical Research Ethics Committee of The University of Queensland (2017000864) and the Children’s Health Queensland Hospital and Health Service Human Research Ethics Committee (HREC/17/QRCH/87). Participant information and consent forms will be provided to all participants and their caregivers before entering the study. Full written and informed consent will be obtained from all caregivers of adolescents participating in the trial. This trial has been registered with the Australian and New Zealand Clinical Trial Registry.
Provenance and peer review Not commissioned; externally peer reviewed.
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