Back to resultsSocial Motivation Intervention for Children With Autism Spectrum Disorder: Improving Peer Initiation
Primary Purpose
Autism Spectrum Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Social Initiation Motivation Intervention
Sponsored by
About this trial
This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring Pivotal Response Treatment, Applied Behavior Analysis, Peer Initiation, Social Skills Group
Eligibility Criteria
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
Sites / Locations
- Stanford University
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Wait List
Social Initiation Motivation Intervention
Arm Description
Outcomes
Primary Outcome Measures
Initiation Frequency (observational rating of the frequency of child initiations to peers measured from video recording during free play sessions)
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02360449
Brief Title
Social Motivation Intervention for Children With Autism Spectrum Disorder: Improving Peer Initiation
Official Title
Social Motivation Intervention for Children With Autism Spectrum Disorder: Improving Peer Initiation
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
January 2015 (Actual)
Primary Completion Date
July 19, 2017 (Actual)
Study Completion Date
November 5, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
Keywords
Pivotal Response Treatment, Applied Behavior Analysis, Peer Initiation, Social Skills Group
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Wait List
Arm Type
No Intervention
Arm Title
Social Initiation Motivation Intervention
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Social Initiation Motivation Intervention
Other Intervention Name(s)
Pivotal Response Treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Initiation Frequency (observational rating of the frequency of child initiations to peers measured from video recording during free play sessions)
Description
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.
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Grace Gengoux, PhD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
33387236
Citation
Gengoux GW, Schwartzman JM, Millan ME, Schuck RK, Ruiz AA, Weng Y, Long J, Hardan AY. Enhancing Social Initiations Using Naturalistic Behavioral Intervention: Outcomes from a Randomized Controlled Trial for Children with Autism. J Autism Dev Disord. 2021 Oct;51(10):3547-3563. doi: 10.1007/s10803-020-04787-8. Epub 2021 Jan 2.
Results Reference
result
Links:
URL
https://lane.stanford.edu/view/pubmed/33387236
Description
Published primary trial results (Stanford Medical Library link)
Learn more about this trial
Social Motivation Intervention for Children With Autism Spectrum Disorder: Improving Peer Initiation
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