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Multicentre, randomised waitlist control trial investigating a parent-assisted social skills group programme for adolescents with brain injuries: protocol for the friends project
  1. Rose Gilmore1,2,
  2. Leanne Sakzewski1,
  3. Jenny Ziviani3,
  4. Sarah Mcintyre4,
  5. Hayley Smithers Sheedy4,
  6. Nicola Hilton2,
  7. Tracey Williams5,
  8. Kirsten Quinn6,
  9. Anne Marie Sarandrea5,
  10. Elizabeth Laugeson7,
  11. Mark Chatfield1
  1. 1Queensland Cerebral Palsy and Rehabilitation Research Centre, The University of Queensland, Brisbane, Queensland, Australia
  2. 2Queensland Paediatric Rehabilitation Service, Children's Health Queensland Hospital and Health Service, Brisbane, Queensland, Australia
  3. 3School of Health and Rehabilitation Sciences, The University of Queensland, Brisbane, Queensland, Australia
  4. 4Cerebral Palsy Alliance Research Institute, The University of Sydney, Sydney, Queensland, Australia
  5. 5Kids Rehab, The Children's Hospital at Westmead, Sydney, New South Wales, Australia
  6. 6Youth Services Department, Cerebral Palsy Alliance, Sydney, NSW, Australia
  7. 7Semel Institute for Neuroscience and Human Behavior, University of California, Los Angeles, Los Angeles, California, USA
  1. Correspondence to Ms Rose Gilmore; rose.gilmore{at}uq.edu.au

Abstract

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

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

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Footnotes

  • 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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