TY - JOUR
T1 - REACH-ASD
T2 - 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
AU - Leadbitter, Kathy
AU - Smallman, Richard
AU - James, Kirsty
AU - Shields, Gemma
AU - Ellis, Ceri
AU - Langhorne, Sophie
AU - Harrison, Louisa
AU - Hackett, Latha
AU - Dunkerley, Alison
AU - Davies, Linda
AU - Kroll, Leo
AU - Emsley, Richard
AU - Bee, Penny
AU - Green, Jonathan
AU - REACH-ASD Team
N1 - Funding Information:
This study is supported by the United Kingdom Clinical Research Collaboration-registered King’s Clinical Trials Unit at King’s Health Partners, which is part funded by the NIHR Biomedical Research Centre for Mental Health at South London and Maudsley NHS Foundation Trust and King’s College London and the NIHR Evaluation, Trials and Studies Coordinating Centre.
Funding Information:
National Institute for Health and Care Research Health Technology Assessment Programme, Alpha House, Enterprise Road, Southampton, SO16 7NS. Ref: 17/80/09. Initial grant funding: £1,395,164. Variation to contract approved in February 2022 with additional funding of £190,876
Funding Information:
The authors gratefully acknowledge the valued contribution of all the families who are giving their time and efforts to participate in the trial. We also acknowledge educational staff who complete questionnaires. We thank the members of the Trial Steering Committee: Mr Michael Bayliss, Prof Bryony Beresford (Chair), Ms Diaretou Coulibaly, Dr Laura Crane, and Dr Eleanor Smith. We also thank the members of the Data Management and Ethics Committee: Dr Victoria Grahame, Dr Laura Mandefield, and Prof Will Mandy (Chair). We acknowledge the invaluable involvement of our Advisory Group members and the contribution to data collection and processing of Stephen Adams, Henna Ahmed, Annia Argyrou, Reshmi Nijjar, Emma Stephens, and Katy Wilson. We thank all the individuals within our partner sites who referred participants and co-delivered the intervention programme: Central Manchester Child and Adolescent Mental Health Service; Cheshire and Wirral Partnership Trust; East Lancashire Child and Adolescent Services; East Lancashire Community and Neurodevelopmental Paediatrics; North Manchester Child and Adolescent Mental Health Service; Salford Child and Adolescent Mental Health Service; South Manchester Child and Adolescent Mental Health Service; Stockport Autism Team; Stockport Child Development Unit; Tameside and Glossop Child and Adolescent Mental Health Service; and Trafford Autism and Social Communication Team. We acknowledge the foundational work of colleagues within Manchester University NHS Foundation Trust and of Dr Kate Sofranoff, Dr Koa Whittingham, and colleagues of the University of Queensland. This study is supported by the United Kingdom Clinical Research Collaboration-registered King’s Clinical Trials Unit at King’s Health Partners, which is part funded by the NIHR Biomedical Research Centre for Mental Health at South London and Maudsley NHS Foundation Trust and King’s College London and the NIHR Evaluation, Trials and Studies Coordinating Centre. The REACH-ASD Team: Sofia Ahmed1, Hilary Beach2, Charlotte Butter1, June Gilbert2, Caitlin Goldie1, Rebekah Howell1, Tessa Hutton2, Amelia Pearson1, Katy Roe3, Cameron Sawyer1, Amy Van Gils21 University of Manchester, UK; 2 Manchester University NHS Foundation Trust, UK; 3 Mindscape Psychology, UK.
Funding Information:
RE is supported by a NIHR research professorship (NIHR300051) and the NIHR Maudsley Biomedical Research Centre at South London Maudsley NHS Foundation Trust, and King’s College London.
Publisher Copyright:
© 2022, The Author(s).
PY - 2022/7/22
Y1 - 2022/7/22
N2 - 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.
AB - 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.
KW - Acceptance and Commitment Therapy
KW - Autism Spectrum Disorder/diagnosis
KW - Caregivers/psychology
KW - Child
KW - Cost-Benefit Analysis
KW - Humans
KW - Mental Health
KW - Quality of Life
KW - United Kingdom
U2 - 10.1186/s13063-022-06524-1
DO - 10.1186/s13063-022-06524-1
M3 - Article
C2 - 35869533
SN - 1745-6215
VL - 23
JO - Trials
JF - Trials
IS - 1
M1 - 585
ER -