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

NCT ID: NCT06011707

Last Updated: 2024-05-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

308 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-30

Study Completion Date

2028-03-31

Brief Summary

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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

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Conditions

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Autism Spectrum Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators
The students who will be conducting the interviews for the primary objective of the study (using the Vineland Adaptive Behavior Scales, Version 3) will be blind to the treatment arm the family is assigned to.

Study Groups

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OPT-IN intervention

Group Type EXPERIMENTAL

OPT-IN

Intervention Type BEHAVIORAL

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).

Psychoeducational control

Group Type ACTIVE_COMPARATOR

Psychoeducational control

Intervention Type OTHER

This control intervention will provide parents with 6 compulsory and 8 optional modules that will teach them about autism and its developmental course.

Interventions

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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).

Intervention Type BEHAVIORAL

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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

12 Months

Maximum Eligible Age

60 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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McMaster Children's Hospital

OTHER

Sponsor Role collaborator

Holland Bloorview Kids Rehabilitation Hospital

OTHER

Sponsor Role collaborator

Children's Hospital of Eastern Ontario

OTHER

Sponsor Role collaborator

Child and Community Resources

UNKNOWN

Sponsor Role collaborator

Elizabeth Kelley

OTHER

Sponsor Role lead

Responsible Party

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Elizabeth Kelley

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

Responsibility Role SPONSOR_INVESTIGATOR

Central Contacts

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Elizabeth A Kelley, PhD

Role: CONTACT

613-533-2491

Other Identifiers

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OPTIN

Identifier Type: -

Identifier Source: org_study_id

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