Parent Training to Enhance Social Success for Children With Autism Spectrum Disorder
Primary Purpose
Autism Spectrum Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Social SUCCESS
Wait List
Sponsored by
About this trial
This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring parent training, social skills
Eligibility Criteria
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)
Sites / Locations
- Stanford University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Social SUCCESS
Wait List
Arm Description
Outcomes
Primary Outcome Measures
Change in Visual Analog Scale Rating from Baseline to 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
Secondary Outcome Measures
Change in frequency of child initiations
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
Change in parent fidelity of implementation
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
Social Responsiveness Scale, Second Edition
Social Responsiveness Scale, Second Edition, Parent Report Form
Social Skills Improvement System
Social Skills Improvement System Parent Report Form
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03177525
Brief Title
Parent Training to Enhance Social Success for Children With Autism Spectrum Disorder
Official Title
Parent Training to Enhance Social Success for Children With Autism Spectrum Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
August 9, 2017 (Actual)
Primary Completion Date
November 12, 2021 (Actual)
Study Completion Date
November 23, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
Keywords
parent training, social skills
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Social SUCCESS
Arm Type
Experimental
Arm Title
Wait List
Arm Type
Other
Intervention Type
Behavioral
Intervention Name(s)
Social SUCCESS
Intervention Description
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".
Intervention Type
Behavioral
Intervention Name(s)
Wait List
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Visual Analog Scale Rating from Baseline to Week 12
Description
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
Time Frame
Baseline, Week 12
Secondary Outcome Measure Information:
Title
Change in frequency of child initiations
Description
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
Time Frame
Baseline, Week 12
Title
Change in parent fidelity of implementation
Description
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
Time Frame
Baseline, Week 12
Title
Social Responsiveness Scale, Second Edition
Description
Social Responsiveness Scale, Second Edition, Parent Report Form
Time Frame
Baseline, Week 12, 3-month Follow-up
Title
Social Skills Improvement System
Description
Social Skills Improvement System Parent Report Form
Time Frame
Baseline, Week 12, 3-month Follow-up
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:
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Grace W 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
Plan to Share IPD
No
Learn more about this trial
Parent Training to Enhance Social Success for Children With Autism Spectrum Disorder
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