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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Autism Spectrum Disorder
• Intervention / Treatment: Behavioral: OPT-IN; Other: Psychoeducational control

• Study Type: Interventional
• Enrollment (Estimated): 308
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elizabeth A Kelley, PhD; Phone Number: 613-533-2491; Email: kelleyb@queensu.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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)

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2023
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: April 24, 2023
• First Submitted That Met QC Criteria: August 23, 2023
• First Posted (Actual): August 25, 2023

Study Record Updates

• Last Update Posted (Actual): August 25, 2023
• Last Update Submitted That Met QC Criteria: August 23, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
• Other Study ID Numbers: OPTIN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be shared with other researchers through this website. The data will be de-identified by eliminating birthdate.
• IPD Sharing Time Frame: The data will be made available after publication for 15 years.
• IPD Sharing Access Criteria: Data will be obtained through the clinicaltrials.gov website
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No