NCT03177525

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 6, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

August 9, 2017

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 12, 2021

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 23, 2021

Completed
Last Updated

December 10, 2021

Status Verified

December 1, 2021

Enrollment Period

4.3 years

First QC Date

June 1, 2017

Last Update Submit

December 9, 2021

Conditions

Keywords

parent trainingsocial skills

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

EXPERIMENTAL
Behavioral: Social SUCCESS

Wait List

OTHER
Behavioral: Wait List

Interventions

Social SUCCESSBEHAVIORAL

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".

Social SUCCESS
Wait ListBEHAVIORAL

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.

Wait List

Eligibility Criteria

Age4 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

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

Location

MeSH Terms

Conditions

Autism Spectrum DisorderSocial Skills

Interventions

Waiting Lists

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental DisordersSocial BehaviorBehavior

Intervention Hierarchy (Ancestors)

Appointments and SchedulesOrganization and AdministrationHealth Services Administration

Study Officials

  • Grace W Gengoux, PhD

    Stanford University

    PRINCIPAL INVESTIGATOR

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

Locations