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Kathy Leadbitter, Richard Smallman, Kirsty James, Gemma Shields, Ceri Ellis, Sophie Langhorne, Louisa Harrison, Latha Hackett, et al.
(2022).
REACH-ASD: a UK randomised controlled trial of a new post-diagnostic psycho-education and acceptance and commitment therapy programme against treatment-as-usual for improving the mental health and adjustment of caregivers of children recently diagnosed with autism spectrum disorder.
Trials, 23(1), 585.
Springer Science and Business Media LLC.
- Publication date
-
22 Jul 2022
- Identifier
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10.1186/s13063-022-06524-1
- Authors
-
Kathy Leadbitter,
Richard Smallman,
Kirsty James,
Gemma Shields,
Ceri Ellis,
Sophie Langhorne,
Louisa Harrison,
Latha Hackett,
Alison Dunkerley,
Leo Kroll,
Linda Davies,
Richard Emsley,
Penny Bee,
Jonathan Green,
The REACH-ASD Team,
Sofia Ahmed,
Hilary Beach,
Charlotte Butter,
June Gilbert,
Caitlin Goldie,
Rebekah Howell,
Tessa Hutton,
Amelia Pearson,
Katy Roe,
Cameron Sawyer,
Amy Van Gils
- Source
- Trials
- Details
- 23(1), 585
- Reference type
- article
- Publisher
- Springer Science and Business Media LLC
- Metadata source
- crossref
Abstract
Abstract Background Autism is a neurodevelopmental disability affecting over 1% of UK children. The period following a child’s autism diagnosis can present real challenges in adaptation for families. Twenty to 50% of caregivers show clinically significant levels of mental health need within the post-diagnostic period and on an ongoing basis. Best practice guidelines recommend timely post-diagnostic family support. Current provision is patchy, largely unevidenced, and a source of dissatisfaction for both families and professionals. There is a pressing need for an evidenced programme of post-diagnostic support focusing on caregiver mental health and adjustment, alongside autism psycho-education. This trial tests the clinical and cost-effectiveness of a new brief manualised psychosocial intervention designed to address this gap. Methods This is a multi-centre two-parallel-group single (researcher)-blinded randomised controlled trial of the Empower-Autism programme plus treatment-as-usual versus usual local post-diagnostic offer plus treatment-as-usual. Caregivers of children aged 2–15 years with a recent autism diagnosis will be recruited from North West England NHS or local authority centres. Randomisation is individually by child, with one “index” caregiver per child, stratified by centre, using 2:1 randomisation ratio to assist recruitment and timely intervention. Empower-Autism is a group-based, manualised, post-diagnostic programme that combines autism psycho-education and psychotherapeutic components based on Acceptance and Commitment Therapy to support caregiver mental health, stress management and adjustment to their child’s diagnosis. The comparator is any usual local group-based post-diagnostic psycho-education offer. Receipt of services will be specified through health economic data. Primary outcome: caregiver mental health (General Health Questionnaire-30) at 52-week follow-up. Secondary outcomes: key caregiver measures (wellbeing, self-efficacy, adjustment, autism knowledge) at 12-, 26- and 52-week follow-up and family and child outcomes (wellbeing and functioning) at 52-week endpoint. Sample: N =380 (approximately 253 intervention/127 treatment-as-usual). Primary analysis will follow intention-to-treat principles using linear mixed models with random intercepts for group membership and repeated measures. Cost-effectiveness acceptability analyses will be over 52 weeks, with decision modelling to extrapolate to longer time periods. Discussion If effective, this new approach will fill a key gap in the provision of evidence-based care pathways for autistic children and their families. Trial registration ISRCTN 45412843. Prospectively registered on 11 September 2019.
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