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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04953793
Other study ID # R34MH111491
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date November 6, 2017
Est. completion date December 31, 2020

Study information

Verified date June 2021
Source Rady Children's Hospital, San Diego
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

By utilizing community-based participatory research methods, this research was conducted in collaboration with the community through our partnership of researchers, educators, providers and consumers (Active Collaborative Hub for Individuals with ASD to Enhance Vocation and Education- ACHIEVE) to adapt a vocational soft skills program, Supported, Comprehensive Cognitive Enhancement & Social Skills (SUCCESS), for Transition Age Youth (TAY). The first step (years 1-2) involved adapting the intervention for autistic TAY by including feedback from multiple stakeholders and developing a curriculum to be implemented in both High Schools and Transition programs for the specific needs of autistic TAY and alpha piloting it. It involved understanding further the educational context for TAY students and current services available to prepare students for secondary outcomes of employment and/or college through a county wide survey. Step 2 (years 2-3) included pilot testing the feasibility, acceptability, implementation procedures and initial youth outcomes of the TAY SUCCESS intervention and further refining the curriculum and protocols. Findings demonstrated improvements in executive functioning and social functioning targets as well as distal outcomes of self-efficacy, mental health, educational and work behaviors and attitudes. The study results were disseminated through the ACHIEVE group as well as at conferences, website and publication.


Description:

Aim: With our ACHIEVE partners , develop the High School Supported, Comprehensive Cognitive Enhancement and Social Skills (SUCCESS) program to fit the needs of transition-age youth with ASD within the community educational system. 1. Standardize the TAY SUCCESS program by developing a facilitator manual, student workbook and corresponding support person materials. 2. Develop a training protocol that can be individualized and implemented within the HS educational system to provide initial training and ongoing coaching for educators to reach and sustain intervention fidelity. Aim: Conduct a pilot study to examine the feasibility, acceptability, and implementation procedures (recruitment, randomization, retention & training strategies) of TAY SUCCESS and to obtain estimates of effects to support a future large-scale effectiveness trial. 1. Examine intervention feasibility, acceptability, satisfaction, and sustainability. 2. Examine preliminary outcomes (executive functioning and social functioning)


Recruitment information / eligibility

Status Completed
Enrollment 42
Est. completion date December 31, 2020
Est. primary completion date January 20, 2020
Accepts healthy volunteers No
Gender All
Age group 15 Years to 22 Years
Eligibility Inclusion Criteria: - autism spectrum disorder - 15-22 yrs - communicative English language - enrolled in participating high school or transition program Exclusion Criteria: - intellectual disability - Other significant mental health

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
TAY SUCCESS
TAY SUCCESS stands for transition age youth supported, comprehensive cognitive enhancement and social skills. The cognitive-behavioral intervention teaches a number of strategies for executive functioning, social cognitive functioning and social communication.
Other:
Usual Care
Usual care involved the typical vocational supportive education program delivered in the educational setting

Locations

Country Name City State
United States Rady Children's Hospital San Diego San Diego California

Sponsors (1)

Lead Sponsor Collaborator
Rady Children's Hospital, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Behavior Rating Inventory of Executive Function (BRIEF-2/BRIEF-A) Self and Parent report of executive functioning skills. Higher scores indicate more executive functioning problems baseline to 6 month post
Primary Delis Kaplan Executive Function Scale (DKEFS) performance based measure of executive functioning skills. Higher scores indicate more executive functioning abilities baseline to 6 month post
Primary Social Responsiveness Scale 2 (SRS-2) parent report social functioning scale. Higher scores indicate more social functioning problems baseline to 6 month post
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