Clinical trial NCT05695885: STEPS Implementation Trial
Official title: Stepped Transition in Education Program for Emerging Adults With Autism: Pilot Effectiveness Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: transition
adulthood
employment
education
Lead sponsor: University of Alabama, Tuscaloosa
Sponsor class: OTHER
First posted: 2023-01-25
Enrollment: 80
Sex: ALL
Minimum age (years): 16
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel RCT
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study will inform understanding of how to support emerging adults with autism spectrum disorder (ASD). The investigators will use a theoretically informed and research-based transition support program developed for people with ASD and test how effective it is when delivered by community agencies. Results will provide information on the effectiveness of the program as well as on mechanisms of change and contextual factors that promote or impede implementation.

Detailed description: The long-term goal of this research is to improve adult outcomes for people with autism spectrum disorder (ASD). Autistic adolescents and young adults tend to have worse outcomes with respect to employment, education, and quality of life, than neurotypical peers. These outcomes include under-enrollment into college, unemployment, and limited functional independence. Research-informed transition planning that addresses core impairments in skills related to adult autonomy, including self-knowledge, self-determination, and self-regulation, may improve outcomes for this growing population. In prior research, investigators developed a stakeholder involved transition program (STEPS) and found it to be feasible, acceptable, and efficacious. Data from a small randomized controlled trial (RCT) focusing on feasibility indicated that it was acceptable to participants and suggested STEPS was effective in improving readiness for transition to adulthood. The team will now test the effectiveness of STEPS, and engagement of target mechanisms, in partnership with four community agencies. This study is designed as a Hybrid Type 1, which focuses primarily on intervention effectiveness with a secondary focus on factors related to implementation. Immediate (post-treatment) and longer-term (six month follow-up) clinical outcomes of adult functional outcomes and vocational engagement will be assessed. The degree to which STEPS leads to change in the theoretical mediating mechanisms (i.e., adult autonomy skills) will be examined, as well as a formal test of mediation (i.e., the degree to which change in adult autonomy skills leads to change in adult functional outcomes). Providers will provide qualitative information on implementation such as thoughts on STEPS' cultural sensitivity, and quantitative data on the appropriateness, feasibility, and acceptability of STEPS. Providers' sustained use of STEPS with clients in the six months after study enrollment has ended will also be tracked. This research will produce findings that have the potential to shift clinical practice related to transition to adulthood for people with ASD. In light of the fact that approximately 70,000 people with ASD age into adulthood every year and the economic burden associated with ASD, the potential public health impact of this research is considerable.

Eligibility criteria: Inclusion Criteria:

* 16-25 years of age
* have confirmed diagnosis of ASD
* want to participate in STEPS
* have a caregiver/parent who can complete assessments

Exclusion Criteria:

* presence of suicidal/homicidal intent

Primary outcomes:
measure: Transition Readiness Scale-Revised
timeFrame: 30 days
Secondary outcomes:
measure: Relationships, Employment, Autonomy, and Life Satisfaction
timeFrame: 30 days
measure: Rehabilitation Success
timeFrame: 30 days
Other outcomes:
Locations:
city: Tuscaloosa
country: United States
facility: Center o=for Youth Development and Intervention
state: Alabama
Study officials:
References: