Parent Training to Enhance Social Success for Children With Autism Spectrum Disorder

Autism Spectrum Disorder Clinical Trial

Official title:

Parent Training to Enhance Social Success for Children With Autism Spectrum Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03177525
• Other study ID #: 41867
• Status: Completed
• Phase: N/A
• Start date: August 9, 2017
• Est. completion date: November 23, 2021

Study information

• Verified date: December 2021
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: November 23, 2021
• Est. primary completion date: November 12, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 6 Years

Eligibility

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)

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder
• Child Development Disorders, Pervasive

Intervention

Behavioral:
• 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".
• Wait List
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.

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	Baseline, Week 12
Secondary	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	Baseline, Week 12
Secondary	Social Responsiveness Scale, Second Edition	Social Responsiveness Scale, Second Edition, Parent Report Form	Baseline, Week 12, 3-month Follow-up
Secondary	Social Skills Improvement System	Social Skills Improvement System Parent Report Form	Baseline, Week 12, 3-month Follow-up