Thompson Bianca, Gilmore Rose, Hilton Nicola, Barfoot Jacqui, Moody Christine T, Whittingham Koa, Keramat Afroz, Boyd Roslyn N, Sakzewski Leanne
Faculty of Medicine, The University of Queensland Child Health Research Centre, South Brisbane, Queensland, Australia
University of Queensland, South Brisbane, Queensland, Australia.
BMJ Open. 2025 Jan 4;15(1):e095354. doi: 10.1136/bmjopen-2024-095354.
Reaching social milestones is an important goal of childhood. Children with acquired brain injury (ABI) and cerebral palsy (CP) frequently experience challenges with social functioning and participation. The Programme for the Education and Enrichment of Relational Skills (PEERS) is a group-based social skills programme for adolescents. This study will compare an adapted PEERS programme with usual care in a pilot randomised waitlist-controlled trial for primary and early high school-aged children with brain injuries.
This single-centre study will be conducted at the Queensland Cerebral Palsy and Rehabilitation Research Centre at the Centre for Children's Health Research in Brisbane, Australia. Thirty-two school-aged children (grades 3+; 8-13 years) with an ABI or CP and their caregiver(s) will be recruited and randomly assigned to either 12 week PEERS Plus or waitlist usual care. The waitlist group will then participate in PEERS Plus after the 3 month retention time point. The primary outcome will measure individualised social participation goals on the Canadian Occupational Performance Measure immediately postintervention at the primary endpoint (12 weeks). Secondary outcomes include the Social Skills Improvement System Social-Emotional Learning Edition Rating Forms and Quality of Play Questionnaire immediately postintervention, 12 weeks postintervention (26 weeks postbaseline), 36 weeks postintervention (52 weeks postbaseline) for retention. Following completion of the PEERS Plus programme, semistructured focus group interviews will be conducted separately with caregivers and children to explore the lived experience of PEERS. Interpretive description will be used to identify patterns and themes related to participants' experiences. Analyses will follow standard principles for randomised controlled trials using two-group comparisons on all participants on an intention-to-treat basis. Comparisons between groups for primary and secondary outcomes will be conducted using regression models. This study will estimate the unit costs of providing PEERS Plus at different levels of public health facilities in Australia.
This study has been approved by the Medical Research Ethics Committee of The University of Queensland (2022/HE002031) and the Children's Health Queensland Hospital and Health Service Human Research Ethics Committee (HREC/22/QCHQ/87450). Recruitment and participant informed consent process will be completed in accordance with institutional ethic procedures. Dissemination plans include peer-review publication of study results, presentations, and instructional workshops at national and international conferences.
ACTRN12623000515695.
实现社会发展里程碑是儿童时期的一个重要目标。获得性脑损伤（ABI）和脑瘫（CP）患儿在社交功能和参与方面经常面临挑战。关系技能教育与提升计划（PEERS）是一项针对青少年的团体社交技能计划。本研究将在一项针对患有脑损伤的小学和初中早期儿童的试点随机等待名单对照试验中，将改编后的PEERS计划与常规护理进行比较。
这项单中心研究将在澳大利亚布里斯班儿童健康研究中心的昆士兰脑瘫与康复研究中心进行。32名患有ABI或CP的学龄儿童（3年级及以上；8 - 13岁）及其照顾者将被招募，并随机分配到为期12周的PEERS Plus组或等待名单常规护理组。等待名单组将在3个月的保留时间点后参加PEERS Plus。主要结局将在主要终点（12周）干预后立即使用加拿大职业表现测量量表测量个体化社交参与目标。次要结局包括干预后立即、干预后12周（基线后26周）、干预后36周（基线后52周）用于保留情况的社交技能改进系统社会情感学习版评分表和游戏质量问卷。在完成PEERS Plus计划后，将分别与照顾者和儿童进行半结构化焦点小组访谈，以探索PEERS的实际体验。将使用解释性描述来确定与参与者体验相关的模式和主题。分析将遵循随机对照试验的标准原则，在所有参与者按意向性分析的基础上进行两组比较。主要和次要结局的组间比较将使用回归模型进行。本研究将估计在澳大利亚不同级别的公共卫生设施中提供PEERS Plus的单位成本。
本研究已获得昆士兰大学医学研究伦理委员会（2022/HE002031）和昆士兰儿童健康医院及卫生服务人类研究伦理委员会（HREC/22/QCHQ/87450）的批准。招募和参与者知情同意过程将按照机构伦理程序完成。传播计划包括在同行评审期刊上发表研究结果、在国内和国际会议上进行报告以及举办指导工作坊。
ACTRN12623000515695。
