Telehealth-delivered naturalistic developmental behavioural intervention with and without caregiver acceptance and commitment therapy for autistic children and their caregivers: protocol for a multi-arm parallel group randomised clinical trial.

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dc.citation.issue5
dc.citation.volume13
dc.contributor.authorMcLay L
dc.contributor.authorEmerson LM
dc.contributor.authorWaddington H
dc.contributor.authorvan Deurs J
dc.contributor.authorHunter J
dc.contributor.authorBlampied N
dc.contributor.authorHapuku A
dc.contributor.authorMacfarlane S
dc.contributor.authorBowden N
dc.contributor.authorvan Noorden L
dc.contributor.authorRispoli M
dc.coverage.spatialEngland
dc.date.accessioned2024-05-22T22:37:14Z
dc.date.available2024-05-22T22:37:14Z
dc.date.issued2023-05-30
dc.description.abstractINTRODUCTION: Timely access to early support that optimises autistic children's development and their caregiver's mental health is critical. Naturalistic developmental behavioural interventions (NDBIs) and acceptance and commitment therapy (ACT) are evidence-based supports that can enhance child learning and behaviour, and adult well-being, respectively. The traditional face-to-face delivery of these approaches is resource intensive. Further, little is known about the benefit of parallel child-focused and caregiver-focused supports. The aims of this trial are to evaluate the effectiveness and social validity of telehealth-delivered, caregiver-implemented, child-focused NDBI and caregiver-focused ACT when delivered alone and in parallel, on autistic children's social communication and caregiver well-being. METHODS AND ANALYSIS: The study will use a randomised, single-blind clinical trial with three parallel arms: NDBI; ACT and ACT+NDBI. We will recruit a minimum of 78, 2-5-year-old autistic children and their families throughout Aotearoa New Zealand. Support will be delivered over 13 weeks using a combination of culturally enhanced web-based modules and online group coaching. Primary outcome variables include children's social communication/engagement with their caregiver as well as caregiver stress and will be evaluated using a repeated measures multivariate analysis of variance. Outcome variables are assessed at baseline (before randomisation), immediately postparticipation and at 3-month follow-up. ETHICS AND DISSEMINATION: The trial is approved by the Health and Disability Ethics Committee (2022 FULL 12058). The findings of this trial will be disseminated through peer-reviewed journals and national and international conference proceedings regardless of the magnitude/direction of effect. Additionally, data will be shared with stakeholder groups, service providers and health professionals. TRIAL REGISTRATION NUMBER: Australian New Zealand Clinical Trials Registry (ACTRN12622001134718).
dc.description.confidentialfalse
dc.edition.edition2023
dc.format.paginatione071235-
dc.identifier.author-urlhttps://www.ncbi.nlm.nih.gov/pubmed/37253492
dc.identifier.citationMcLay L, Emerson LM, Waddington H, van Deurs J, Hunter J, Blampied N, Hapuku A, Macfarlane S, Bowden N, van Noorden L, Rispoli M. (2023). Telehealth-delivered naturalistic developmental behavioural intervention with and without caregiver acceptance and commitment therapy for autistic children and their caregivers: protocol for a multi-arm parallel group randomised clinical trial.. BMJ Open. 13. 5. (pp. e071235-).
dc.identifier.doi10.1136/bmjopen-2022-071235
dc.identifier.eissn2044-6055
dc.identifier.elements-typejournal-article
dc.identifier.issn2044-6055
dc.identifier.numbere071235
dc.identifier.piibmjopen-2022-071235
dc.identifier.urihttps://mro.massey.ac.nz/handle/10179/69645
dc.languageeng
dc.publisherBMJ Publishing Group Limited
dc.publisher.urihttps://bmjopen.bmj.com/content/13/5/e071235
dc.relation.isPartOfBMJ Open
dc.rights(c) 2023 The Author/s
dc.rightsCC BY 4.0
dc.rights.urihttps://creativecommons.org/licenses/by/4.0/
dc.subjectClinical trials
dc.subjectCommunity child health
dc.subjectDevelopmental neurology & neurodisability
dc.subjectMENTAL HEALTH
dc.subjectAdult
dc.subjectHumans
dc.subjectChild, Preschool
dc.subjectAcceptance and Commitment Therapy
dc.subjectCaregivers
dc.subjectAutistic Disorder
dc.subjectSingle-Blind Method
dc.subjectAustralia
dc.subjectTelemedicine
dc.subjectRandomized Controlled Trials as Topic
dc.titleTelehealth-delivered naturalistic developmental behavioural intervention with and without caregiver acceptance and commitment therapy for autistic children and their caregivers: protocol for a multi-arm parallel group randomised clinical trial.
dc.typeJournal article
pubs.elements-id461930
pubs.organisational-groupOther
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