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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02360449
Other study ID # 31420
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2015
Est. completion date November 5, 2020

Study information

Verified date January 2021
Source Stanford University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 44
Est. completion date November 5, 2020
Est. primary completion date July 19, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 4 Years to 6 Years
Eligibility Inclusion Criteria: 1. age 4.0 to 6.11 years; 2. diagnosis of Autism Spectrum Disorder 3. without intellectual disability 4. stable community treatments four weeks before and throughout the trial. Exclusion criteria: 1. diagnosed severe psychiatric or genetic disorder or medical problem; 2. severe disruptive behavior that would interfere with peer interactions

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
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.

Locations

Country Name City State
United States Stanford University Stanford California

Sponsors (1)

Lead Sponsor Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 8 weeks
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