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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05581069
Other study ID # A22-0209
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 15, 2022
Est. completion date August 1, 2024

Study information

Verified date November 2023
Source University of Alabama, Tuscaloosa
Contact Susan W White
Phone 2053481967
Email swwhite1@ua.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this study is to conduct the first community-based implementation of the STEPS program and test feasibility and preliminary impact. After first working with stakeholders to refine and optimize the program we will launch a Hybrid Type 1 open trial, targeting 25 transition-age youth (TAY) with ASD.


Description:

This community-engaged, applied research study will test the effectiveness of STEPS (Stepped Transition in Education Program for Students with ASD), a program designed to help transition-age youth (TAY) with ASD prepare for independence. Adults with ASD have worse outcomes, with respect to employment, education, and quality of life, than neurotypical peers. Research-informed transition planning that addresses core impairments in skills needed for autonomous and independent living, including self-knowledge, self-determination, and self-regulation, may improve outcomes for this growing population. In a prior trial, the investigators found STEPS to be feasible, acceptable, and efficacious. The proposed study is the first test of STEPS as implemented by community-based providers. Through a series of implementation working group meetings with identified community partner agency and stakeholders (families, TAY with ASD) in the region, the study team will refine STEPS with the goal of optimizing program sustainability within community settings. Following this, a Hybrid Type 1 open trial will be launched, which focuses primarily on intervention effectiveness with a secondary focus on factors related to implementation. With a sample of TAY with ASD (n=25) immediate and longer-term clinical outcomes of adult functional outcomes and vocational engagement will be assessed. This research will produce findings with the potential to shift clinical practice related to transition to adulthood for people with ASD.


Recruitment information / eligibility

Status Recruiting
Enrollment 25
Est. completion date August 1, 2024
Est. primary completion date May 1, 2024
Accepts healthy volunteers No
Gender All
Age group 16 Years to 25 Years
Eligibility Inclusion Criteria: - ages 16-25 confirmed diagnosis of ASD caregiver willing to participate stable medication Exclusion Criteria: - evidence of intellectual disability evidence of suicidal intent

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
STEPS
STEPS is a psychosocial intervention that targets self-determination, self-regulation, and self-knowledge to improve functional independence and quality of life in adults.

Locations

Country Name City State
United States Center for Youth Development and Intervention Tuscaloosa Alabama

Sponsors (1)

Lead Sponsor Collaborator
University of Alabama, Tuscaloosa

Country where clinical trial is conducted

United States, 

References & Publications (3)

Elias R, White SW. Autism Goes to College: Understanding the Needs of a Student Population on the Rise. J Autism Dev Disord. 2018 Mar;48(3):732-746. doi: 10.1007/s10803-017-3075-7. — View Citation

White SW, Elias R, Capriola-Hall NN, Smith IC, Conner CM, Asselin SB, Howlin P, Getzel EE, Mazefsky CA. Development of a College Transition and Support Program for Students with Autism Spectrum Disorder. J Autism Dev Disord. 2017 Oct;47(10):3072-3078. doi: 10.1007/s10803-017-3236-8. — View Citation

White SW, Smith IC, Miyazaki Y, Conner CM, Elias R, Capriola-Hall NN. Improving Transition to Adulthood for Students with Autism: A Randomized Controlled Trial of STEPS. J Clin Child Adolesc Psychol. 2021 Mar-Apr;50(2):187-201. doi: 10.1080/15374416.2019.1669157. Epub 2019 Oct 14. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Adult Functioning Scale The Adult Functioning Scale measures autonomy, employment (including readiness), social functioning, and satisfaction via self- and informant-report questionnaires Week 14
Primary Rehabilitation Success This is completed via interview to assess 'real world' vocational engagement Week 14
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