Improving Outcomes in Autism: Community Implementation of Stepped Transition in Education Program
Primary Purpose
Autism Spectrum Disorder
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
STEPS
Sponsored by
About this trial
This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring autism, adult, transition, employment
Eligibility Criteria
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
Sites / Locations
- Center for Youth Development and InterventionRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
STEPS
Arm Description
All participants receive the STEPS intervention
Outcomes
Primary Outcome Measures
Adult Functioning Scale
The Adult Functioning Scale measures autonomy, employment (including readiness), social functioning, and satisfaction via self- and informant-report questionnaires
Rehabilitation Success
This is completed via interview to assess 'real world' vocational engagement
Secondary Outcome Measures
Full Information
NCT ID
NCT05581069
First Posted
September 29, 2022
Last Updated
October 11, 2022
Sponsor
University of Alabama, Tuscaloosa
1. Study Identification
Unique Protocol Identification Number
NCT05581069
Brief Title
Improving Outcomes in Autism: Community Implementation of Stepped Transition in Education Program
Official Title
Improving Outcomes in Autism: Community Implementation of Stepped Transition in Education Program
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 15, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
February 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alabama, Tuscaloosa
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
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
Keywords
autism, adult, transition, employment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This is a single-arm (non-randomized) trial in which providers are community-based practitioners.
Masking
None (Open Label)
Masking Description
The assessment battery is multi-modal and includes evaluation by an independent evaluator (IE) who is uninvolved in STEPS delivery or training.
Allocation
N/A
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
STEPS
Arm Type
Experimental
Arm Description
All participants receive the STEPS intervention
Intervention Type
Behavioral
Intervention Name(s)
STEPS
Intervention Description
STEPS is a psychosocial intervention that targets self-determination, self-regulation, and self-knowledge to improve functional independence and quality of life in adults.
Primary Outcome Measure Information:
Title
Adult Functioning Scale
Description
The Adult Functioning Scale measures autonomy, employment (including readiness), social functioning, and satisfaction via self- and informant-report questionnaires
Time Frame
Week 14
Title
Rehabilitation Success
Description
This is completed via interview to assess 'real world' vocational engagement
Time Frame
Week 14
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Susan W White
Phone
2053481967
Email
swwhite1@ua.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Nicole Powell
Phone
2053483535
Email
npowell@ua.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan W White
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Youth Development and Intervention
City
Tuscaloosa
State/Province
Alabama
ZIP/Postal Code
35487
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicole Powell, PhD
Phone
205-348-3535
Email
npowell@ua.edu
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There is no pre-existing plan, but de-identified data will be shared after publication of main findings, upon request.
Citations:
PubMed Identifier
31609666
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.
Results Reference
background
PubMed Identifier
28255760
Citation
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.
Results Reference
background
PubMed Identifier
28685409
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.
Results Reference
background
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Improving Outcomes in Autism: Community Implementation of Stepped Transition in Education Program
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