Autism Spectrum Disorder Clinical Trial
Official title:
Social Motivation Intervention for Children With Autism Spectrum Disorder: Improving Peer Initiation
| 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 |
| Verified date | January 2021 |
| Source | Stanford University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Stanford University | Stanford | California |
| Lead Sponsor | Collaborator |
|---|---|
| Stanford University |
United States,
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
| 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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