High School SUCCESS: Vocational Soft Skills Program for Transition-Age ASD Youth (TAY SUCCESS)
Primary Purpose
Autism Spectrum Disorder
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
TAY SUCCESS
Usual Care
Sponsored by
About this trial
This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring executive functioning, social cognitions, social communication, transition age youth
Eligibility Criteria
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
Sites / Locations
- Rady Children's Hospital San Diego
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
TAY SUCCESS intervention
Usual Care
Arm Description
This intervention group received the TAY SUCCESS intervention over the course of 1 school year approximately 30 sessions.
This usual care group received typical High school or transition program curriculum over the course of 1 school year.
Outcomes
Primary Outcome Measures
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
Delis Kaplan Executive Function Scale (DKEFS)
performance based measure of executive functioning skills. Higher scores indicate more executive functioning abilities
Social Responsiveness Scale 2 (SRS-2)
parent report social functioning scale. Higher scores indicate more social functioning problems
Secondary Outcome Measures
Full Information
NCT ID
NCT04953793
First Posted
June 11, 2021
Last Updated
June 28, 2021
Sponsor
Rady Children's Hospital, San Diego
1. Study Identification
Unique Protocol Identification Number
NCT04953793
Brief Title
High School SUCCESS: Vocational Soft Skills Program for Transition-Age ASD Youth
Acronym
TAY SUCCESS
Official Title
High School SUCCESS: Vocational Soft Skills Program for Transition-Age ASD Youth
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
November 6, 2017 (Actual)
Primary Completion Date
January 20, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rady Children's Hospital, San Diego
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
Standardize the TAY SUCCESS program by developing a facilitator manual, student workbook and corresponding support person materials.
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.
Examine intervention feasibility, acceptability, satisfaction, and sustainability.
Examine preliminary outcomes (executive functioning and social functioning)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
Keywords
executive functioning, social cognitions, social communication, transition age youth
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
A small feasibility randomized clinical trial with randomization occurring at school site level. Two sites randomized to intervention and two sites randomized to control conditions.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TAY SUCCESS intervention
Arm Type
Experimental
Arm Description
This intervention group received the TAY SUCCESS intervention over the course of 1 school year approximately 30 sessions.
Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
This usual care group received typical High school or transition program curriculum over the course of 1 school year.
Intervention Type
Behavioral
Intervention Name(s)
TAY SUCCESS
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Usual Care
Intervention Description
Usual care involved the typical vocational supportive education program delivered in the educational setting
Primary Outcome Measure Information:
Title
Behavior Rating Inventory of Executive Function (BRIEF-2/BRIEF-A)
Description
Self and Parent report of executive functioning skills. Higher scores indicate more executive functioning problems
Time Frame
baseline to 6 month post
Title
Delis Kaplan Executive Function Scale (DKEFS)
Description
performance based measure of executive functioning skills. Higher scores indicate more executive functioning abilities
Time Frame
baseline to 6 month post
Title
Social Responsiveness Scale 2 (SRS-2)
Description
parent report social functioning scale. Higher scores indicate more social functioning problems
Time Frame
baseline to 6 month post
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Rady Children's Hospital San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
12. IPD Sharing Statement
Learn more about this trial
High School SUCCESS: Vocational Soft Skills Program for Transition-Age ASD Youth
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