- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05581069
Improving Outcomes in Autism: Community Implementation of Stepped Transition in Education Program
November 29, 2023 updated by: University of Alabama, Tuscaloosa
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.
Study Overview
Detailed 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.
Study Type
Interventional
Enrollment (Estimated)
25
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Susan W White
- Phone Number: 2053481967
- Email: swwhite1@ua.edu
Study Contact Backup
- Name: Nicole Powell
- Phone Number: 2053483535
- Email: npowell@ua.edu
Study Locations
-
-
Alabama
-
Tuscaloosa, Alabama, United States, 35487
- Recruiting
- Center for Youth Development and Intervention
-
Contact:
- Nicole Powell, PhD
- Phone Number: 205-348-3535
- Email: npowell@ua.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 21 years (Child, Adult)
Accepts Healthy Volunteers
No
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: STEPS
All participants receive the STEPS intervention
|
STEPS is a psychosocial intervention that targets self-determination, self-regulation, and self-knowledge to improve functional independence and quality of life in adults.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adult Functioning Scale
Time Frame: Week 14
|
The Adult Functioning Scale measures autonomy, employment (including readiness), social functioning, and satisfaction via self- and informant-report questionnaires
|
Week 14
|
|
Rehabilitation Success
Time Frame: Week 14
|
This is completed via interview to assess 'real world' vocational engagement
|
Week 14
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Susan W White, University of Alabama at Birmingham
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 15, 2022
Primary Completion (Estimated)
May 1, 2024
Study Completion (Estimated)
August 1, 2024
Study Registration Dates
First Submitted
September 29, 2022
First Submitted That Met QC Criteria
October 11, 2022
First Posted (Actual)
October 14, 2022
Study Record Updates
Last Update Posted (Actual)
November 30, 2023
Last Update Submitted That Met QC Criteria
November 29, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- A22-0209
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
There is no pre-existing plan, but de-identified data will be shared after publication of main findings, upon request.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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