Award Title: REACH-ASD Trial: A Randomised Controlled Trial of Psychoeducation and Acceptance & Commitment Therapy for Parents of Children recently diagnosed with ASD
Funder: Department of Health and Social Care

Abstract: Background: There are high levels of mental health difficulties in parents of children with Autism Spectrum Disorder (ASD). The period following their child’s diagnosis can be particularly challenging. Groups that educate parents about ASD are often used in the NHS but have not been evaluated and we do not know if they help parents’ mental health. An intervention called Acceptance and Commitment Therapy (ACT) has been used with parents of children with disabilities with some evidence of success. It uses problem solving, mindfulness, and practical exercises to help people reflect on their current situation and manage any distressing experiences and thoughts. Our programme (EMPOWER-ASD) combines education about autism with ACT and we consider this the best approach to help parents’ mental health and to support them in adapting to parenting their child with ASD._x000D_
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Aims: To find out if EMPOWER-ASD benefits parents and their families when delivered as part of NHS care, using a randomised controlled trial. We want to know (1) whether it improves parent mental health, wellbeing, confidence and knowledge about ASD, (2) if it improves the wellbeing of the wider family and the child with ASD and (3) if it provides value for money._x000D_
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Methods: An initial 10-month period will be used to run 3 intervention groups, seek parent and practitioner feedback, and make any necessary adjustments. The next 4 months will be a pilot of the trial to make sure that we can easily recruit parents to take part. The main trial will last 28 months. Participants will be 380 parents/primary carers with a child aged 2-15 years diagnosed with ASD within the previous year. They will be referred from NHS ASD assessment centres. They will be allocated at random to the intervention group or to the “usual care” group. The intervention group will be offered 5 group-based sessions delivered by a mental health practitioner along with ASD experts. These sessions focus on education about ASD, strategies to help communication and behaviour, navigating the education system and accessing support. They also introduce and practise ACT strategies. The intervention group will have access to supporting online resources._x000D_
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We will measure parents’ mental health, wellbeing, knowledge and self-confidence using questionnaires and interviews at the beginning of the trial and over the course of a year. We will also measure aspects of wellbeing for the whole family and for the child with ASD. We will compare the two trial groups on differences in these areas. We will collect details of all other support used by parents to compare the costs of services for each group and to assess whether any improvements are value for money._x000D_
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Involvement of parents: The research team includes two parents of children with ASD who will give the parent perspective on all aspects of the project. A advisory group of parents, including an autistic parent, will advise on whether trial information and interview questions are tailored to parents’ needs. We have already sought parents’ views on the intervention and will continue to do so throughout the trial._x000D_
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Sharing trial results: The progress of the trial and its findings will be shared with parents, the ASD community and NHS professionals through workshops, social media and websites, and parent and professional networks. The results will be published in scientific journals and presented at conferences. If this intervention works it will be shared with NHS teams, filling an important gap within NHS care.

Lay Abstract: 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. _x000D_
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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._x000D_
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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._x000D_
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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._x000D_
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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. _x000D_
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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.

Research Activity Codes: 6.6 PSYCHOLOGICAL AND BEHAVIOURAL
Health Categories: MENTAL HEALTH