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NCT05695885 | Recruiting | Autism Spectrum Disorder


STEPS Implementation Trial
Sponsor:

University of Alabama, Tuscaloosa

Information provided by (Responsible Party):

Susan White

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.

Condition or disease

Autism Spectrum Disorder

Intervention/treatment

STEPS

Services as usual (SAU)

Phase

Not Applicable

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.}}

Study Type : Interventional
Estimated Enrollment : 80 participants
Masking : Single
Masking Description : The main outcome measure is completed by a trained evaluator unaware of assigned treatment condition (i.e., the Independent Evaluator; IE).
Primary Purpose : Health Services Research
Official Title : Stepped Transition in Education Program for Emerging Adults With Autism: Pilot Effectiveness Trial
Actual Study Start Date : April 1, 2023
Estimated Primary Completion Date : April 1, 2025
Estimated Study Completion Date : December 6, 2025
Arm Intervention/treatment

Experimental: STEPS

14 session counseling targeting adult independence skills

Behavioral: STEPS

Other: Control

Services as usual

Behavioral: Services as usual (SAU)

Ages Eligible for Study: 16 Years to 25 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Accepts Healthy Volunteers
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

STEPS Implementation Trial

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STEPS Implementation Trial

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Locations


Recruiting

United States, Alabama

Center o=for Youth Development and Intervention

Tuscaloosa, alabama, United States, 35487

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