Clinical trial NCT05581069: 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
Overall status: RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: autism
adult
transition
employment
Lead sponsor: University of Alabama, Tuscaloosa
Sponsor class: OTHER
First posted: 2022-10-14
Enrollment: 25
Sex: ALL
Minimum age (years): 16
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a single-arm (non-randomized) trial in which providers are community-based practitioners.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Adult Functioning Scale
timeFrame: Week 14
measure: Rehabilitation Success
timeFrame: Week 14
Secondary outcomes:
Other outcomes:
Locations:
city: Tuscaloosa
country: United States
facility: Center for Youth Development and Intervention
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Susan W White
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.