NCT Number: NCT06011707
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:
1. Does an online intervention for autistic children result in improved adaptive behaviour, compared to a psychoeducational control group? 2. 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? 3. 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.
Trial opening soon.
Get Notified12 month–60 month
All sexes
Interventional
Not applicable
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
This control intervention will provide parents with 6 compulsory and 8 optional modules that will teach them about autism and its developmental course.
Time frame: baseline, post-intervention (6 months past baseline), follow-up (6 months past post-intervention)
Change in Vineland Adaptive Behavior Scales, 3rd Edition Parent interview
Time frame: baseline, post-intervention (6 months past baseline), follow-up (6 months past post-intervention)
Change in Autism Impact Measure
Time frame: baseline, post-intervention (6 months past baseline), follow-up (6 months past post-intervention)
Change in Parenting Stress Index, Short Form, version 4
Time frame: baseline, post-intervention (6 months past baseline), follow-up (6 months past post-intervention)
Change in Early Intervention Parenting Self-Efficacy Scale
Time frame: baseline, post-intervention (6 months past baseline), follow-up (6 months past post-intervention)
Change in MacArthur-Bates Communicative Development Inventory
Contact information is provided by the study sponsor or research team.
Elizabeth Kelley
Other
OPT-IN: Online Parent Training Intervention for Young Children Diagnosed With Autism Spectrum Disorder: A Randomized Controlled Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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