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.
Acceptance and commitment therapy
Autism
Caregivers
Diagnosis
Psycho-education
Randomised controlled trial
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
22 Jul 2022
22 Jul 2022
Historique:
received:
07
04
2022
accepted:
06
07
2022
entrez:
22
7
2022
pubmed:
23
7
2022
medline:
27
7
2022
Statut:
epublish
Résumé
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. 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. caregiver mental health (General Health Questionnaire-30) at 52-week follow-up. 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. 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. If effective, this new approach will fill a key gap in the provision of evidence-based care pathways for autistic children and their families. ISRCTN 45412843 . Prospectively registered on 11 September 2019.
Sections du résumé
BACKGROUND
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
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
METHODS
caregiver mental health (General Health Questionnaire-30) at 52-week follow-up.
SECONDARY OUTCOMES
RESULTS
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
METHODS
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
CONCLUSIONS
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
BACKGROUND
ISRCTN 45412843 . Prospectively registered on 11 September 2019.
Identifiants
pubmed: 35869533
doi: 10.1186/s13063-022-06524-1
pii: 10.1186/s13063-022-06524-1
pmc: PMC9306249
doi:
Types de publication
Journal Article
Multicenter Study
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
585Subventions
Organisme : Medical Research Council
ID : MR/K005863/1
Pays : United Kingdom
Organisme : Health Technology Assessment Programme
ID : 17/80/09
Investigateurs
Sofia Ahmed
(S)
Hilary Beach
(H)
Charlotte Butter
(C)
June Gilbert
(J)
Caitlin Goldie
(C)
Rebekah Howell
(R)
Tessa Hutton
(T)
Amelia Pearson
(A)
Katy Roe
(K)
Cameron Sawyer
(C)
Amy Van Gils
(A)
Informations de copyright
© 2022. The Author(s).
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