Social skills group training (KONTAKT™) for Chinese autistic children: a feasibility wait-list RCT protocol

IntroductionSchool-aged autistic children commonly experience social communication and interaction challenges in their everyday lives. While international evidence suggests that social skills group training (SSGT) programmes can support autistic children, improving their psycho-social functioning, to date there is no standardised evidence-based SSGT tailored towards the needs of autistic children aged 8 to 12 years living in the Chinese Mainland. Therefore, the primary objective is to evaluate the feasibility and acceptability of a culturally adapted 16-session version of the social skills programme KONTAKT in Chinese autistic children. Additionally, preliminary efficacy and cost-effectiveness will be assessed to inform a future definitive trial. Methods and analysisThis study will employ a randomised, single-blinded, wait-list controlled feasibility design with 36 Chinese autistic children aged 8 to 12 years with Intelligence Quotient over 70 referred to the Child Development Behaviour Centre, in Guangzhou, China. Participants will be randomly assigned to either the immediate training group or the delayed training group stratified by sex. Feasibility will be assessed using quantitative and qualitative data obtained from the KONTAKT CHILD participants, their parents, and facilitators of the programme. Preliminary efficacy and cost-effectiveness are assessed via quantitative data obtained at five time points. The primary efficacy outcome is participants improvement in social skills as measured by the Contextual Assessment of Social Skills (CASS). Other outcomes include parents and teachers reports of participants autistic traits and adaptive functioning, participants self-report and projective tests for self-assertiveness and psycho-social functioning, and parent reports on parental reflective functioning and perceived school support. Common process factors and their effects on outcomes will also be explored. Cost-effectiveness will consider both societal and healthcare perspectives. Ethics and disseminationThe current study protocol has been reviewed and ethics approval has been obtained from the Ethical Board Committee at the Third Affiliated Hospital of Sun Yat-sen University (II2023-119-01). The trial was pre-registered in Chinese Clinical Trials (ChiCTR2300072136) on 2023 June 05. The results of this trial will be actively disseminated through peer-reviewed publications and conference presentations. Any identifiable personal information will be anonymised to protect confidentiality. Protocol version2.0, 2024 July 31 Strengths and limitations of this studyO_LIComprehensive assessment of diverse outcomes via multiple informants. C_LIO_LISystematic cultural adaptation using the Integrative Cultural Adaptation Framework (ICAF) C_LIO_LIensuring the appropriateness of the Chinese version of KONTAKT. C_LIO_LICollect data on readiness for change, providing insights into "help-seeker" effects. C_LIO_LILimited generalisability due to a single study site, location-specific inclusion, and absence of an active comparator. C_LIO_LIGiven the absence of previous research examining the efficacy of SSGT programs in autistic children in the Chinese Mainland, this study is appropriately a feasibility study. As such, only the preliminary efficacy of KONTAKT with this population in a small sample will be examined. The small sample size will limit the power of the study in examining the effect of moderators on the study outcomes. C_LI