McLay LEmerson LMWaddington Hvan Deurs JHunter JBlampied NHapuku AMacfarlane SBowden Nvan Noorden LRispoli M2024-05-222024-05-222023-05-30McLay 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-).2044-6055https://mro.massey.ac.nz/handle/10179/69645INTRODUCTION: 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).(c) 2023 The Author/sCC BY 4.0https://creativecommons.org/licenses/by/4.0/Clinical trialsCommunity child healthDevelopmental neurology & neurodisabilityMENTAL HEALTHAdultHumansChild, PreschoolAcceptance and Commitment TherapyCaregiversAutistic DisorderSingle-Blind MethodAustraliaTelemedicineRandomized Controlled Trials as TopicJournal article10.1136/bmjopen-2022-0712352044-6055journal-articlee071235-https://www.ncbi.nlm.nih.gov/pubmed/37253492e071235bmjopen-2022-071235