Abstract
AbstractIntroductionSchool-aged autistic children commonly experience social communication and interaction challenges in their daily lives. While internationally 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 children living in Mainland China. Therefore, this study will evaluate the feasibility, acceptability, preliminary efficacy, and cost-effectiveness of a culturally-adapted 16-session version of the KONTAKTTMprogramme in Chinese autistic children.Methods and analysisThis study will employed 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 (ITG) or the delayed training group (DTG) based on birth-assigned sex. Feasibility will be assessed using quantitative and qualitative data obtained from the KONTAKTTMparticipants, their parents, and facilitators of the programme. Preliminary efficacy and cost-effectiveness are assessed via quantitative data obtained at five-time points. The primary outcome is participants improvement in social skills as measured by the Contextual Assessment of Social Skills (CASS). Other outcomes include parents and teachers report of participants’ autistic trait and adaptive functioning, participants self-report and projective tests for self-assertiveness and psycho-social functioning, and parent report 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 has pre-registered in Chinese Clinical Trials (ChiCTR2300072136) on 05 June 2023. The results of this trial will be actively disseminated through peer-reviewed publications and conference presentations.Strengths and limitations of this studyComprehensive assessment of diverse outcomes via multiple informants.Systematic cultural adaptation using the Integrative Cultural Adaptation Framework (ICAF) ensuring the appropriateness of the Chinese version of KONTAKTTM.Collect data on readiness for change, providing insights into “help-seeker” effects.Limited generalisability due to a single study site, location-specific inclusion, and absence of active comparator.Uncertain psychometric properties of certain measures due to a lack of Chinese population data.
Publisher
Cold Spring Harbor Laboratory