- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03177525
Parent Training to Enhance Social Success for Children With Autism Spectrum Disorder
December 9, 2021 updated by: Grace Gengoux, Stanford University
Children with autism spectrum disorder (ASD) exhibit characteristic deficits in social initiation and there are no empirically validated treatments specifically for this core deficit.
While parent training is known to be a critical intervention component, few social skills programs involve parents.
This study will capitalize on an existing social skills group already established at the community agency Abilities United, with the goal of enhancing the program's effectiveness by adding a parent component.
Specifically, the proposed study will investigate whether a novel parent mediated social skills program (Social SUCCESS), which provides parent training in conjunction with a social skills group intervention, will result in more frequent initiations during play with typically developing peers.
Participants will include 50 children with ASD age 4:0 to 6:11 years.
Children will be randomly assigned to either Social SUCCESS (N=25) or waiting list (N=25).
Treatment will be provided for 8 weeks during a weekly 120-minute social skills group at Abilities United.
The study will evaluate the effects of Social SUCCESS on areas of core social deficit including frequency of peer initiations using parent ratings, observational measures, standardized questionnaires, and a social eye tracking task.
Outcomes will be compared to a waiting list control group.
Findings will be disseminated through presentations and publications to aid clinicians in providing more effective social skills treatment for children with ASD and to enhance the scientific knowledge-base related to evidence-based social skills treatments.
This research designed with the goal of stimulating additional scientific inquiry in the area of treatment for core social deficits in ASD and will provide a strong foundation for larger scale grants to study motivation-based interventions to improve social functioning.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
22
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
-
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California
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Stanford, California, United States, 94305
- Stanford University
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-
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
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- child aged 4.0 to 6.11 years
- child diagnosed with ASD (Autism Diagnostic Observation Schedule; ADOS-2)
- child without intellectual disability (Stanford Binet Intelligence Scales; SB-5)
- parent able to consistently participate in parent training sessions and complete study measures
Exclusion Criteria:
- child with other severe psychiatric disorder
- child with known genetic condition (e.g., Fragile X, Retts)
- child with unstable medical condition (e.g., active seizures)
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
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Social SUCCESS
|
Social SUCCESS will run for 12 weeks, with up to 5 children with ASD per group.
Parents will attend didactic group sessions focused on motivating children with ASD to initiate to peers (90 min weekly) and will attend a portion of the existing 90 min social group to practice applying these strategies with their children and peer volunteers.
Parent training will utilize the manual "Improving Socialization in Individuals with Autism".
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OTHER: Wait List
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Participants assigned to the Wait List will continue stable community treatments for 12 weeks and will be provided an intervention similar to Social SUCCESS upon completion of all post measures.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Visual Analog Scale Rating from Baseline to Week 12
Time Frame: Baseline, Week 12
|
Parent rating on a Visual Analog Scale (VAS) of the child's frequency of initiation will be compared between Baseline and Week 12 to evaluate change
|
Baseline, Week 12
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in frequency of child initiations
Time Frame: Baseline, Week 12
|
Based on behavioral coding of peer play videos by a blind rater using established operational definitions, change between baseline and week 12 in frequency of child initiations will be compared between groups
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Baseline, Week 12
|
|
Change in parent fidelity of implementation
Time Frame: Baseline, Week 12
|
Changes in prompting and reinforcement of social initiations between baseline and week 12 scored from video of parent-child interaction by trained raters will be compared between groups
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Baseline, Week 12
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|
Social Responsiveness Scale, Second Edition
Time Frame: Baseline, Week 12, 3-month Follow-up
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Social Responsiveness Scale, Second Edition, Parent Report Form
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Baseline, Week 12, 3-month Follow-up
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Social Skills Improvement System
Time Frame: Baseline, Week 12, 3-month Follow-up
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Social Skills Improvement System Parent Report Form
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Baseline, Week 12, 3-month Follow-up
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Grace W Gengoux, PhD, Stanford University
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)
August 9, 2017
Primary Completion (ACTUAL)
November 12, 2021
Study Completion (ACTUAL)
November 23, 2021
Study Registration Dates
First Submitted
June 1, 2017
First Submitted That Met QC Criteria
June 2, 2017
First Posted (ACTUAL)
June 6, 2017
Study Record Updates
Last Update Posted (ACTUAL)
December 10, 2021
Last Update Submitted That Met QC Criteria
December 9, 2021
Last Verified
December 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 41867
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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