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

NCT06011707 | Not Yet Recruiting DMC

• 1 other identifier: OPTIN
• Study Type: interventional
• Target: 308
• Locations: 0 countries
• Sites: N/A

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. 1.Does an online intervention for autistic children result in improved adaptive behaviour, compared to a psychoeducational control group?
2. 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. 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).

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in Autism Symptoms

  baseline, post-intervention (6 months past baseline), follow-up (6 months past post-intervention)

• Change in Parenting Stress

  baseline, post-intervention (6 months past baseline), follow-up (6 months past post-intervention)

• Change in Parental Self-Efficacy

  baseline, post-intervention (6 months past baseline), follow-up (6 months past post-intervention)

• Change in Language

  baseline, post-intervention (6 months past baseline), follow-up (6 months past post-intervention)

Study Arms (2)

OPT-IN intervention

EXPERIMENTAL

Behavioral: OPT-IN

Psychoeducational control

ACTIVE COMPARATOR

Other: Psychoeducational control

Interventions

OPT-IN BEHAVIORAL

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).

OPT-IN intervention

Psychoeducational control OTHER

This control intervention will provide parents with 6 compulsory and 8 optional modules that will teach them about autism and its developmental course.

Psychoeducational control

Eligibility Criteria

• Age: 12 Months - 60 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Child diagnosed with Autism or Autism Spectrum Disorder within the last six months at baseline

You may not qualify if:

• 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.

Sponsors & Collaborators

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

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Central Study Contacts

Elizabeth A Kelley, PhD

CONTACT

613-533-2491; kelleyb@queensu.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr. Elizabeth Kelley, PhD, Associate professor of Psychology and Psychiatry and CNS, Queen's University

Study Record Dates

• First Submitted: April 24, 2023
• First Posted: August 25, 2023
• Study Start: June 30, 2024
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: May 13, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: The data will be made available after publication for 15 years.
• Access Criteria: Data will be obtained through the clinicaltrials.gov website