Clinical trial NCT06011707: OPT-IN: Online Parent Training Intervention for Young Children Diagnosed With Autism Spectrum Disorder
Official title: OPT-IN: Online Parent Training Intervention for Young Children Diagnosed With Autism Spectrum Disorder: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder
Lead sponsor: Queen's University
Sponsor class: OTHER
Collaborators: name: McMaster Children's Hospital
name: Holland Bloorview Kids Rehabilitation Hospital
name: Children's Hospital of Eastern Ontario
name: Child and Community Resources
First posted: 2023-08-25
Enrollment: 308
Sex: ALL
Minimum age (years): 12
Maximum age (years): 60
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change in Adaptive Behavior
timeFrame: baseline, post-intervention (6 months past baseline), follow-up (6 months past post-intervention)
Secondary outcomes:
measure: Change in Autism Symptoms
timeFrame: baseline, post-intervention (6 months past baseline), follow-up (6 months past post-intervention)
measure: Change in Parenting Stress
timeFrame: baseline, post-intervention (6 months past baseline), follow-up (6 months past post-intervention)
measure: Change in Parental Self-Efficacy
timeFrame: baseline, post-intervention (6 months past baseline), follow-up (6 months past post-intervention)
measure: Change in Language
timeFrame: baseline, post-intervention (6 months past baseline), follow-up (6 months past post-intervention)
Other outcomes:
Locations:
Study officials:
References: