Clinical trial NCT03177525: 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
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: parent training
social skills
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2017-06-06
Enrollment: 22
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Change in Visual Analog Scale Rating from Baseline to Week 12
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Change in frequency of child initiations
timeFrame: Baseline, Week 12
measure: Change in parent fidelity of implementation
timeFrame: Baseline, Week 12
measure: Social Responsiveness Scale, Second Edition
timeFrame: Baseline, Week 12, 3-month Follow-up
measure: Social Skills Improvement System
timeFrame: Baseline, Week 12, 3-month Follow-up
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Grace W Gengoux, PhD
role: PRINCIPAL_INVESTIGATOR
References: