OPT-IN: Online Parent Training Intervention for Young Children Diagnosed With Autism Spectrum Disorder

Study Overview
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Brief Summary
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The goal of this observer-blinded randomized controlled clinical trial is to determine the effectiveness of a fully-online, parent-mediated, video-based, self-directed intervention for young children with autism (12-60 months) who have been diagnosed with autism in the last six months. The main question[s] it aims to answer are: Does an online intervention for autistic children result in improved adaptive behaviour, compared to a psychoeducational control group? Does an online intervention for autistic children result in reduced autism symptoms in children, and decreased stress and increased self-efficacy in parents, compared to a psychoeducational control group? What are the predictors of response to intervention (i.e., child sex and age; initial autism symptoms and adaptive behavior; and parent self-efficacy, stress, and education). Parents will be given six compulsory and eight optional online modules that will teach them skills to use while interacting with their autistic children to improve social and communication behaviours and minimize behaviours that interfere with learning. The comparison group will receive six compulsory and eight optional online modules that will teach them about autism more broadly including diagnostic criteria, symptom profiles across development, etc.

Official Title
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OPT-IN: Online Parent Training Intervention for Young Children Diagnosed With Autism Spectrum Disorder: A Randomized Controlled Trial

Conditions
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Autism Spectrum Disorder

Intervention / Treatment
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* Behavioral: OPT-IN
* Other: Psychoeducational control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Child diagnosed with Autism or Autism Spectrum Disorder within the last six months at baseline Exclusion Criteria: Parent does not speak English well enough to complete questionnaires Parent or child has complete vision or hearing loss. Parent or child is medically unstable.

Ages Eligible for Study
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Minimum Age: 12 Months
Maximum Age: 60 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OPT-IN intervention<br> | Behavioral: OPT-IN<br>* Parents will be provided with online access to 6 compulsory video-based modules and 8 optional video-based modules. These modules will teach them about child development, behavioural principles, and naturalistic developmental intervention principles. These modules will promote skills that parents can use to increase their child's social and communication behaviours and minimize behaviours that interfere with learning (e.g., temper tantrums).<br>|
| Active Comparator: Psychoeducational control<br> | Other: Psychoeducational control<br>* This control intervention will provide parents with 6 compulsory and 8 optional modules that will teach them about autism and its developmental course.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Adaptive Behavior | Change in Vineland Adaptive Behavior Scales, 3rd Edition Parent interview | baseline, post-intervention (6 months past baseline), follow-up (6 months past post-intervention) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Autism Symptoms | Change in Autism Impact Measure | baseline, post-intervention (6 months past baseline), follow-up (6 months past post-intervention) | 
| Change in Parenting Stress | Change in Parenting Stress Index, Short Form, version 4 | baseline, post-intervention (6 months past baseline), follow-up (6 months past post-intervention) | 
| Change in Parental Self-Efficacy | Change in Early Intervention Parenting Self-Efficacy Scale | baseline, post-intervention (6 months past baseline), follow-up (6 months past post-intervention) | 
| Change in Language | Change in MacArthur-Bates Communicative Development Inventory | baseline, post-intervention (6 months past baseline), follow-up (6 months past post-intervention) |