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

• Sponsor: Elizabeth Kelley (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06011707
• Collaborator: McMaster Children's Hospital (Other), Holland Bloorview Kids Rehabilitation Hospital (Other), Children's Hospital of Eastern Ontario (Other), Child and Community Resources (Other)
• Enrollment: 308
• Arms: 2
• Anticipated Duration (Months): 52

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Autism Spectrum Disorder	Behavioral: OPT-IN; Other: Psychoeducational control	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 308 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• 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.
• Primary Purpose: Treatment
• Official Title: OPT-IN: Online Parent Training Intervention for Young Children Diagnosed With Autism Spectrum Disorder: A Randomized Controlled Trial
• Anticipated Study Start Date: Nov 1, 2023
• Anticipated Primary Completion Date: Mar 1, 2028
• Anticipated Study Completion Date: Mar 1, 2028

Arms and Interventions

Arm	Intervention/Treatment
Experimental: OPT-IN intervention	Behavioral: OPT-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).
Active Comparator: Psychoeducational control	Other: Psychoeducational control; This control intervention will provide parents with 6 compulsory and 8 optional modules that will teach them about autism and its developmental course.

Outcome Measures

Primary Outcome Measures

1. Change in Adaptive Behavior [baseline, post-intervention (6 months past baseline), follow-up (6 months past post-intervention)]

   Change in Vineland Adaptive Behavior Scales, 3rd Edition Parent interview

Secondary Outcome Measures

1. Change in Autism Symptoms [baseline, post-intervention (6 months past baseline), follow-up (6 months past post-intervention)]

   Change in Autism Impact Measure

2. Change in Parenting Stress [baseline, post-intervention (6 months past baseline), follow-up (6 months past post-intervention)]

   Change in Parenting Stress Index, Short Form, version 4

3. Change in Parental Self-Efficacy [baseline, post-intervention (6 months past baseline), follow-up (6 months past post-intervention)]

   Change in Early Intervention Parenting Self-Efficacy Scale

4. Change in Language [baseline, post-intervention (6 months past baseline), follow-up (6 months past post-intervention)]

   Change in MacArthur-Bates Communicative Development Inventory

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Months to 60 Months
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Elizabeth Kelley
• McMaster Children's Hospital
• Holland Bloorview Kids Rehabilitation Hospital
• Children's Hospital of Eastern Ontario
• Child and Community Resources

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Elizabeth Kelley, Dr. Elizabeth Kelley, PhD, Associate professor of Psychology and Psychiatry and CNS, Queen's University, Queen's University
• ClinicalTrials.gov Identifier: NCT06011707
• Other Study ID Numbers: OPTIN
• First Posted: Aug 25, 2023
• Last Update Posted: Aug 25, 2023
• Last Verified: Aug 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive

Study Results

No Results Posted as of Aug 25, 2023