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

Not Applicable

Not yet recruiting

• Conditions: Autism Spectrum Disorder
• Interventions: Other: Psychoeducational control; Behavioral: OPT-IN

• Registration Number: NCT06011707
• Lead Sponsor: Elizabeth Kelley

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-24
• Study First Submitted QC: 2023-08-23
• Study First Posted: 2023-08-25
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-09
• Last Update Posted: 2024-05-13
• Study Start: 2024-06-30
• Primary Completion: 2028-03
• Study Completion: 2028-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 308

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Psychoeducational control	Psychoeducational control	-
OPT-IN intervention	OPT-IN	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
Change in Autism Symptoms	baseline, post-intervention (6 months past baseline), follow-up (6 months past post-intervention)	Change in Autism Impact Measure
Change in Language	baseline, post-intervention (6 months past baseline), follow-up (6 months past post-intervention)	Change in MacArthur-Bates Communicative Development Inventory
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