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Clinical Trials/NCT06011707
NCT06011707
Not Yet Recruiting
N/A

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

Elizabeth Kelley0 sites308 target enrollmentJune 30, 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Autism Spectrum Disorder
Sponsor
Elizabeth Kelley
Enrollment
308
Primary Endpoint
Change in Adaptive Behavior
Status
Not Yet Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 30, 2024
End Date
March 2028
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Elizabeth Kelley
Responsible Party
Sponsor Investigator
Principal Investigator

Elizabeth Kelley

Dr. Elizabeth Kelley, PhD, Associate professor of Psychology and Psychiatry and CNS, Queen's University

Queen's University

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Change in Adaptive Behavior

Time Frame: 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 Outcomes

  • Change in Parenting Stress(baseline, post-intervention (6 months past baseline), follow-up (6 months past post-intervention))
  • Change in Autism Symptoms(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))
  • Change in Parental Self-Efficacy(baseline, post-intervention (6 months past baseline), follow-up (6 months past post-intervention))

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