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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06011707
Enrollment
308
Registered
2023-08-25
Start date
2024-06-30
Completion date
2028-03-31
Last updated
2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism Spectrum Disorder

Brief summary

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.

Interventions

BEHAVIORALOPT-IN

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.

Sponsors

McMaster Children's Hospital
CollaboratorOTHER
Holland Bloorview Kids Rehabilitation Hospital
CollaboratorOTHER
Children's Hospital of Eastern Ontario
CollaboratorOTHER
Child and Community Resources
CollaboratorUNKNOWN
Elizabeth Kelley
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Masking description

The students who will be conducting the interviews for the primary objective of the study (using the Vineland Adaptive Behavior Scales, Version 3) will be blind to the treatment arm the family is assigned to.

Eligibility

Sex/Gender
ALL
Age
12 Months to 60 Months
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in Adaptive Behaviorbaseline, post-intervention (6 months past baseline), follow-up (6 months past post-intervention)Change in Vineland Adaptive Behavior Scales, 3rd Edition Parent interview

Secondary

MeasureTime frameDescription
Change in Autism Symptomsbaseline, post-intervention (6 months past baseline), follow-up (6 months past post-intervention)Change in Autism Impact Measure
Change in Parenting Stressbaseline, post-intervention (6 months past baseline), follow-up (6 months past post-intervention)Change in Parenting Stress Index, Short Form, version 4
Change in Parental Self-Efficacybaseline, post-intervention (6 months past baseline), follow-up (6 months past post-intervention)Change in Early Intervention Parenting Self-Efficacy Scale
Change in Languagebaseline, post-intervention (6 months past baseline), follow-up (6 months past post-intervention)Change in MacArthur-Bates Communicative Development Inventory

Contacts

Primary ContactElizabeth A Kelley, PhD
kelleyb@queensu.ca613-533-2491

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026