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Not yet recruiting NCT06011707

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

No phase Interventional Autism Spectrum Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: OPT-IN, Psychoeducational control.
Who it may be relevant to
Registry conditions: Autism Spectrum Disorder. Basic parameters: 12 months — 60 months · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Change in Adaptive Behavior [Time frame: baseline, post-intervention (6 months past baseline), follow-up (6 months past post-intervention)]
Secondary outcome measures (4)
  • Change in Autism Symptoms [Time frame: baseline, post-intervention (6 months past baseline), follow-up (6 months past post-intervention)]
  • Change in Parenting Stress [Time frame: baseline, post-intervention (6 months past baseline), follow-up (6 months past post-intervention)]
  • Change in Parental Self-Efficacy [Time frame: baseline, post-intervention (6 months past baseline), follow-up (6 months past post-intervention)]
  • Change in Language [Time frame: baseline, post-intervention (6 months past baseline), follow-up (6 months past post-intervention)]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06011707 · OPTIN

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗