- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02360449
Social Motivation Intervention for Children With Autism Spectrum Disorder: Improving Peer Initiation
January 6, 2021 updated by: Grace Gengoux, Stanford University
The purpose of this study is to investigate whether a social initiation motivation intervention (SIMI) focused on training children with ASD to initiate to peers during structured play activities will result in more frequent initiations to typically developing peers during free play.
The SIMI approach under investigation uses behavioral strategies based in Applied Behavior Analysis and Pivotal Response Treatment to motivate children with ASD to initiate to peers.
Children with ASD will be randomly assigned to either the SIMI or a waiting list.
Treatment will be provided for 8 weeks in the context of a weekly social skills group.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
44
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Stanford, California, United States, 94305
- Stanford University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
4 years to 6 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- age 4.0 to 6.11 years;
- diagnosis of Autism Spectrum Disorder
- without intellectual disability
- stable community treatments four weeks before and throughout the trial.
Exclusion criteria:
- diagnosed severe psychiatric or genetic disorder or medical problem;
- severe disruptive behavior that would interfere with peer interactions
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Wait List
|
|
Experimental: Social Initiation Motivation Intervention
|
The SIMI approach under investigation uses behavioral strategies based in Applied Behavior Analysis and Pivotal Response Treatment to motivate children with ASD to initiate to peers.
The adult arranges the play environment in order to promote cooperation and facilitates frequent prompting and reinforcement from peers, thereby enhancing the reward value of peer interactions.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Initiation Frequency (observational rating of the frequency of child initiations to peers measured from video recording during free play sessions)
Time Frame: 8 weeks
|
The primary measure is an observational rating of the frequency of child initiations to peers measured from video recording during free play sessions at baseline and post-treatment.
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Grace Gengoux, PhD, Stanford University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2015
Primary Completion (Actual)
July 19, 2017
Study Completion (Actual)
November 5, 2020
Study Registration Dates
First Submitted
February 5, 2015
First Submitted That Met QC Criteria
February 9, 2015
First Posted (Estimate)
February 10, 2015
Study Record Updates
Last Update Posted (Actual)
January 8, 2021
Last Update Submitted That Met QC Criteria
January 6, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 31420
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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