REACH-ASD Trial: A Randomised Controlled Trial of Psychoeducation and Acceptance & Commitment Therapy for Parents of Children recently diagnosed with ASD

Background: There are high levels of mental health difficulties in parents of children with Autism Spectrum Disorder (ASD), particularly in the post-diagnostic period. ASD psychoeducation is common NHS practice, but provision is patchy and it does not have a robust evidence base, nor does it directly target parental mental health. Acceptance and Commitment Therapy (ACT) has an emergent evidence base for improving the mental health of parents of a child with disability, but is currently rarely used in UK practice. Aims and Objectives: To evaluate the EMPOWER-ASD intervention, a parental group-based manualised post-diagnostic programme that combines ASD psychoeducation and ACT psychological support: (1) To complete testing of acceptability, qualitative analysis and finalisation of the programme (feasibility phase); (2) To complete an implementation process evaluation; (3) To test intervention effectiveness over treatment as usual (TAU) on: (a) parental mental health, wellbeing, knowledge, adjustment, stress and self-efficacy; (b) family wellbeing, (c) child wellbeing, behaviour and adaptive functioning; (4) To assess its cost-effectiveness. Methods: A multi-centre two parallel group single (researcher)-blinded randomised controlled trial of the EMPOWER-ASD programme plus TAU versus TAU alone. Individual randomisation by child, with one “index” parent per child, and stratification by centre, using 2:1 randomisation ratio to assist recruitment and deliver timely treatment. Initial feasibility phase and internal pilot to test recruitment, both with pre-specified progression criteria. Population: parents/primary carers of children 2-15 years with recent ASD diagnosis. Primary outcome: parental mental health (General Health Questionnaire-30) at 52-week follow-up. Secondary outcomes: key parent measures at 12-, 26- and 52-week follow-up and family and child outcomes at 52-week endpoint. Sample: N=380 (256 intervention/124 TAU). Primary analysis will follow intention-to-treat principles. Treatment effects will be analysed using linear mixed models with random intercepts for group membership. Cost-effectiveness acceptability analyses over 52 weeks, with decision modelling to extrapolate to longer time periods. Timeline: 49-month project: 3-month start-up; 10-month feasibility phase; 4-month internal pilot (n=60; 4 centres; 4 intervention groups); 28-month main trial (n=320); 4 months for data analysis and dissemination. Impact: This study will give the first systematic evidence for a comprehensive post-diagnostic parent-focussed programme for ASD. The intervention is scalable within the NHS and will meet an identified evidence gap in the Improving Access to Psychological Therapy curriculum for ASD and in future modification of NICE guidelines. If effective, the intervention will deliver direct benefits to parents, children with ASD, and whole family systems. It will reduce parental service use and promote efficient take-up of further parent-mediated ASD interventions. Dissemination: A series of high impact publications and presentations at national and international meetings. Trial protocol will be lodged with scientific journal. Intervention manual to be published and disseminated through professional training. Trial progress and findings shared with parents, the scientific community, and all stakeholders through events, web and social media, newsletters, and parent and researcher networks.