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.

INTRODUCTION: 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).

Evaluating a Two-Tiered Parent Coaching Intervention for Young Autistic Children Using the Early Start Denver Model.

Objectives: Early intervention can improve the outcomes of young autistic children, and parents may be well placed to deliver these interventions. The Early Start Denver Model (ESDM) is a naturalistic developmental behavioral intervention that can be implemented by parents with their own children (P-ESDM). This study evaluated a two-tiered P-ESDM intervention that used a group parent coaching program, and a 1:1 parent coaching program. We evaluated changes in parent use of the ESDM and parent stress, as well as child engagement, communication, and imitation. Methods: Seven autistic or probably autistic children (< 60 months old) and their parents participated. A multiple-baseline design was used to compare individual changes between Baseline 1, Group Coaching (Tier 1), Baseline 2, and 1:1 Coaching (Tier 2). Parent and child behaviors were analyzed from weekly videos and graphed. Parenting stress was measured. Results: All parents improved in their use of ESDM strategies after the Tier 1 intervention. Changes in parent fidelity during Tier 2 were mixed, but all parents maintained higher than baseline levels of fidelity. Six parents demonstrated above 75% ESDM fidelity in at least one session. There were positive changes in parent stress levels pre- post-intervention. Positive results were found for most children's levels of engagement, imitation, and communication. There were significant positive relationships between parent fidelity and both child engagement and child functional utterances. Conclusions: Group P-ESDM is a promising approach for improving parent fidelity and some child outcomes. Future randomized and controlled studies of group P-ESDM, using standardized outcome measures, are warranted. Supplementary Information: The online version contains supplementary material available at 10.1007/s41252-022-00264-8.