{
    "abstract": "Caregivers of autistic children experience particularly poor levels of mental health and increased caregiving complexities. Proactive post-diagnostic family support is recommended but is inconsistently implemented, largely not evidence based, and does not directly address caregiver mental health. This study aimed to test the clinical effectiveness of the Empower-Autism programme plus treatment as usual versus the usual local post-diagnostic psychoeducation offer plus treatment as usual on caregiver mental health at the 52-week follow-up.\nWe did a prospective, multicentre, two-parallel-group, randomised controlled superiority trial of the Empower-Autism programme. Empower-Autism is a group-based, manualised, post-diagnostic programme designed to improve the mental health of caregivers of newly diagnosed autistic children. The programme combines autism psychoeducation and psychotherapeutic components based on Acceptance and Commitment Therapy and was delivered online via videoconferencing. Participants were recruited from 11 North-West England autism diagnostic or intervention centres and were parents or primary caregivers of children aged 2-15 years given an autism diagnosis within the past 12 months. Exclusion criteria were insufficient English language skills, significant learning disability, hearing or visual impairment, or psychiatric condition in caregiver and significant current family safeguarding concerns. Participants were randomly assigned to the intervention or treatment as usual (2:1), stratified by centre. Assessors were masked to group assignment but participants were not. The primary outcome was caregiver mental health assessed by the General Health Questionnaire-30 at 52 weeks. All outcomes were analysed following an intention-to-treat approach using linear mixed models on available cases in the first instance, which resulted in a modified intention-to-treat set due to missing data. Sensitivity analyses on multiply imputed data reflected the full intention-to-treat set. People with lived experience were involved in the trial across all stages. The trial was prospectively registered (ISRCTN 45412843) on Sept 11, 2019, and is complete.\nBetween Sept 16, 2020 and April 14, 2022, 835 potential participants were referred and screened, 384 provided consent, and 379 caregivers were recruited, 255 of whom were randomly assigned to the intervention group and 124 to the treatment as usual group. 333 (88%) participants were female and 46 (12%) were male, with a mean age of 40\u00b76 years (SD 7\u00b73; range 23-69). 294 (78%) of the 379 caregivers were White British, 18 (5%) were White Other, 12 (3%) were Mixed or of multiple ethnicity, 32 (8%) were Asian or Asian British, 16 (4%) were Black or Black British, six (2%) were from any other ethnic group, and one (<1%) had missing ethnicity data. 267 (70%) index children were male, 111 (29%) were female, and one (<1%) was non-binary or other, with a mean age 8\u00b79 years (SD 3\u00b75; range 2\u00b70-16\u00b70). In the available case analysis set (n=319) reflecting a modified intention-to-treat set due to missing data, participants randomly assigned to Empower-Autism had improved mental health at 52 weeks compared with those randomly assigned to treatment as usual (General Health Questionnaire-30 mean difference -4\u00b795 [95% CI -8\u00b721 to -1\u00b768], p=0\u00b70030). 181 adverse events (116 in the Empower-Autism group and 65 in the treatment as usual group) and 15 serious adverse events (nine in the Empower-Autism group and six in the treatment as usual group) were reported; none were deemed to be related to the study intervention. The most common adverse events concerned significant deteriorations in the mental health of caregiver participants or index children and other serious personal issues potentially affecting caregiver mental health.\nTo our knowledge, this is the first fully powered trial to show a statistically and clinically significant sustained effect on mental health in caregivers of newly diagnosed autistic children. In the context of the considerable clinical need in this area, we recommend the use of the Empower-Autism programme to clinicians and policy makers.\nNational Institute for Health and Care Research Health Technology Assessment Programme.",
    "authors": [
        {
            "affiliation": "Division of Psychology & Mental Health, University of Manchester, Manchester, UK. Electronic address: kathy.leadbitter@manchester.ac.uk.",
            "firstname": "Kathy",
            "initials": "K",
            "lastname": "Leadbitter"
        },
        {
            "affiliation": "Division of Psychology & Mental Health, University of Manchester, Manchester, UK.",
            "firstname": "Sophie",
            "initials": "S",
            "lastname": "Langhorne"
        },
        {
            "affiliation": "Division of Psychology & Mental Health, University of Manchester, Manchester, UK.",
            "firstname": "Richard",
            "initials": "R",
            "lastname": "Smallman"
        },
        {
            "affiliation": "Department of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology, and Neuroscience, Kings College London, London, UK.",
            "firstname": "Petrina",
            "initials": "P",
            "lastname": "Chu"
        },
        {
            "affiliation": "Division of Psychology & Mental Health, University of Manchester, Manchester, UK.",
            "firstname": "Ceri",
            "initials": "C",
            "lastname": "Ellis"
        },
        {
            "affiliation": "Division of Psychology & Mental Health, University of Manchester, Manchester, UK.",
            "firstname": "Louisa",
            "initials": "L",
            "lastname": "Harrison"
        },
        {
            "affiliation": "Paediatric Psychosocial Service, Manchester University NHS Foundation Trust, Manchester, UK.",
            "firstname": "Tessa",
            "initials": "T",
            "lastname": "Hutton"
        },
        {
            "affiliation": "Division of Psychology & Mental Health, University of Manchester, Manchester, UK.",
            "firstname": "Charlotte",
            "initials": "C",
            "lastname": "Butter"
        },
        {
            "affiliation": "Division of Psychology & Mental Health, University of Manchester, Manchester, UK.",
            "firstname": "Caitlin",
            "initials": "C",
            "lastname": "Goldie"
        },
        {
            "affiliation": "Department of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology, and Neuroscience, Kings College London, London, UK.",
            "firstname": "Kirsty",
            "initials": "K",
            "lastname": "James"
        },
        {
            "affiliation": "The Winnicott Centre, Manchester University NHS Foundation Trust, Manchester, UK.",
            "firstname": "Latha",
            "initials": "L",
            "lastname": "Hackett"
        },
        {
            "affiliation": "The Winnicott Centre, Manchester University NHS Foundation Trust, Manchester, UK.",
            "firstname": "Alison",
            "initials": "A",
            "lastname": "Dunkerley"
        },
        {
            "affiliation": "Division of Nursing, Midwifery & Social Work, University of Manchester, Manchester, UK.",
            "firstname": "Penny",
            "initials": "P",
            "lastname": "Bee"
        },
        {
            "affiliation": "Division of Population Health, Health Services Research & Primary Care, University of Manchester, Manchester, UK.",
            "firstname": "Gemma",
            "initials": "G",
            "lastname": "Shields"
        },
        {
            "affiliation": "Division of Population Health, Health Services Research & Primary Care, University of Manchester, Manchester, UK.",
            "firstname": "Linda",
            "initials": "L",
            "lastname": "Davies"
        },
        {
            "affiliation": "Department of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology, and Neuroscience, Kings College London, London, UK.",
            "firstname": "Richard",
            "initials": "R",
            "lastname": "Emsley"
        },
        {
            "affiliation": "Division of Psychology & Mental Health, University of Manchester, Manchester, UK; Royal Manchester Children's Hospital, Manchester, UK.",
            "firstname": "Jonathan",
            "initials": "J",
            "lastname": "Green"
        },
        {
            "affiliation": null,
            "firstname": null,
            "initials": null,
            "lastname": null
        }
    ],
    "conclusions": null,
    "copyrights": "Copyright \u00a9 2025 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.",
    "doi": "10.1016/S2215-0366(25)00036-7",
    "journal": "The lancet. Psychiatry",
    "keywords": [],
    "methods": null,
    "publication_date": "2025-03-15",
    "pubmed_id": "40086467",
    "results": null,
    "title": "Clinical effectiveness of an online psychoeducational and psychotherapeutic programme for caregivers of children newly diagnosed as autistic: a parallel, assessor-masked, randomised controlled trial in the UK (REACH-ASD).",
    "xml": "<Element 'PubmedArticle' at 0x7885046cfc40>"
}