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

Autism Spectrum Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06011707
• Other study ID #: OPTIN
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 30, 2024
• Est. completion date: March 2028

Study information

• Verified date: May 2024
• Source: Queen's University
• Contact: Elizabeth A Kelley, PhD
• Phone: 613-533-2491
• Email: kelleyb[@]queensu.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 308
• Est. completion date: March 2028
• Est. primary completion date: March 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Months to 60 Months

Eligibility

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.

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder
• Child Development Disorders, Pervasive

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).

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.

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
Elizabeth Kelley	Child and Community Resources, Children's Hospital of Eastern Ontario, Holland Bloorview Kids Rehabilitation Hospital, McMaster Children's Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in Autism Symptoms	Change in Autism Impact Measure	baseline, post-intervention (6 months past baseline), follow-up (6 months past post-intervention)
Secondary	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)
Secondary	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)
Secondary	Change in Language	Change in MacArthur-Bates Communicative Development Inventory	baseline, post-intervention (6 months past baseline), follow-up (6 months past post-intervention)