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

Primary Purpose

Autism Spectrum Disorder

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
OPT-IN
Psychoeducational control
Sponsored by
Elizabeth Kelley
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder

Eligibility Criteria

12 Months - 60 Months (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    OPT-IN intervention

    Psychoeducational control

    Arm Description

    Outcomes

    Primary Outcome Measures

    Change in Adaptive Behavior
    Change in Vineland Adaptive Behavior Scales, 3rd Edition Parent interview

    Secondary Outcome Measures

    Change in Autism Symptoms
    Change in Autism Impact Measure
    Change in Parenting Stress
    Change in Parenting Stress Index, Short Form, version 4
    Change in Parental Self-Efficacy
    Change in Early Intervention Parenting Self-Efficacy Scale
    Change in Language
    Change in MacArthur-Bates Communicative Development Inventory

    Full Information

    First Posted
    April 24, 2023
    Last Updated
    August 23, 2023
    Sponsor
    Elizabeth Kelley
    Collaborators
    McMaster Children's Hospital, Holland Bloorview Kids Rehabilitation Hospital, Children's Hospital of Eastern Ontario, Child and Community Resources
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06011707
    Brief Title
    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

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 1, 2023 (Anticipated)
    Primary Completion Date
    March 2028 (Anticipated)
    Study Completion Date
    March 2028 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Elizabeth Kelley
    Collaborators
    McMaster Children's Hospital, Holland Bloorview Kids Rehabilitation Hospital, Children's Hospital of Eastern Ontario, Child and Community Resources

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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: Does an online intervention for autistic children result in improved adaptive behaviour, compared to a psychoeducational control group? 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? 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Autism Spectrum Disorder

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Masking Description
    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.
    Allocation
    Randomized
    Enrollment
    308 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    OPT-IN intervention
    Arm Type
    Experimental
    Arm Title
    Psychoeducational control
    Arm Type
    Active Comparator
    Intervention Type
    Behavioral
    Intervention Name(s)
    OPT-IN
    Intervention Description
    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
    Other
    Intervention Name(s)
    Psychoeducational control
    Intervention Description
    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 Measure Information:
    Title
    Change in Adaptive Behavior
    Description
    Change in Vineland Adaptive Behavior Scales, 3rd Edition Parent interview
    Time Frame
    baseline, post-intervention (6 months past baseline), follow-up (6 months past post-intervention)
    Secondary Outcome Measure Information:
    Title
    Change in Autism Symptoms
    Description
    Change in Autism Impact Measure
    Time Frame
    baseline, post-intervention (6 months past baseline), follow-up (6 months past post-intervention)
    Title
    Change in Parenting Stress
    Description
    Change in Parenting Stress Index, Short Form, version 4
    Time Frame
    baseline, post-intervention (6 months past baseline), follow-up (6 months past post-intervention)
    Title
    Change in Parental Self-Efficacy
    Description
    Change in Early Intervention Parenting Self-Efficacy Scale
    Time Frame
    baseline, post-intervention (6 months past baseline), follow-up (6 months past post-intervention)
    Title
    Change in Language
    Description
    Change in MacArthur-Bates Communicative Development Inventory
    Time Frame
    baseline, post-intervention (6 months past baseline), follow-up (6 months past post-intervention)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    12 Months
    Maximum Age & Unit of Time
    60 Months
    Accepts Healthy Volunteers
    No
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Elizabeth A Kelley, PhD
    Phone
    613-533-2491
    Email
    kelleyb@queensu.ca

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Data will be shared with other researchers through this website. The data will be de-identified by eliminating birthdate.
    IPD Sharing Time Frame
    The data will be made available after publication for 15 years.
    IPD Sharing Access Criteria
    Data will be obtained through the clinicaltrials.gov website

    Learn more about this trial

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

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