NCT04953793

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Nov 2017

Typical duration for phase_1

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 6, 2017

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2020

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 11, 2021

Completed
27 days until next milestone

First Posted

Study publicly available on registry

July 8, 2021

Completed
Last Updated

July 8, 2021

Status Verified

June 1, 2021

Enrollment Period

2.2 years

First QC Date

June 11, 2021

Last Update Submit

June 28, 2021

Conditions

Keywords

executive functioningsocial cognitionssocial communicationtransition age youth

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • Social Responsiveness Scale 2 (SRS-2)

    parent report social functioning scale. Higher scores indicate more social functioning problems

    baseline to 6 month post

Study Arms (2)

TAY SUCCESS intervention

EXPERIMENTAL

This intervention group received the TAY SUCCESS intervention over the course of 1 school year approximately 30 sessions.

Behavioral: TAY SUCCESS

Usual Care

ACTIVE COMPARATOR

This usual care group received typical High school or transition program curriculum over the course of 1 school year.

Other: Usual Care

Interventions

TAY SUCCESSBEHAVIORAL

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.

TAY SUCCESS intervention

Usual care involved the typical vocational supportive education program delivered in the educational setting

Usual Care

Eligibility Criteria

Age15 Years - 22 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • autism spectrum disorder
  • yrs
  • communicative English language
  • enrolled in participating high school or transition program

You may not qualify if:

  • intellectual disability
  • Other significant mental health

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rady Children's Hospital San Diego

San Diego, California, 92123, United States

Location

MeSH Terms

Conditions

Autism Spectrum DisorderCommunication

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental DisordersBehavior

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2021

First Posted

July 8, 2021

Study Start

November 6, 2017

Primary Completion

January 20, 2020

Study Completion

December 31, 2020

Last Updated

July 8, 2021

Record last verified: 2021-06

Locations