Parent Training to Enhance Social Success for Children With Autism Spectrum Disorder
1 other identifier
interventional
22
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 1, 2017
CompletedFirst Posted
Study publicly available on registry
June 6, 2017
CompletedStudy Start
First participant enrolled
August 9, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 12, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 23, 2021
CompletedDecember 10, 2021
December 1, 2021
4.3 years
June 1, 2017
December 9, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Baseline, Week 12
Secondary Outcomes (4)
Change in frequency of child initiations
Baseline, Week 12
Change in parent fidelity of implementation
Baseline, Week 12
Social Responsiveness Scale, Second Edition
Baseline, Week 12, 3-month Follow-up
Social Skills Improvement System
Baseline, Week 12, 3-month Follow-up
Study Arms (2)
Social SUCCESS
EXPERIMENTALWait List
OTHERInterventions
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".
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Stanford University
Stanford, California, 94305, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Grace W Gengoux, PhD
Stanford University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Associate Professor
Study Record Dates
First Submitted
June 1, 2017
First Posted
June 6, 2017
Study Start
August 9, 2017
Primary Completion
November 12, 2021
Study Completion
November 23, 2021
Last Updated
December 10, 2021
Record last verified: 2021-12
Data Sharing
- IPD Sharing
- Will not share