STEPS Implementation Trial

Autism Spectrum Disorder Clinical Trial

Official title:

Stepped Transition in Education Program for Emerging Adults With Autism: Pilot Effectiveness Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05695885
• Other study ID #: 22-07-5746
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: February 28, 2026

Study information

• Verified date: May 2024
• Source: University of Alabama, Tuscaloosa
• Contact: Susan W White, PhD
• Phone: 2053481967
• Email: swwhite1[@]ua.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: February 28, 2026
• Est. primary completion date: January 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Autism Spectrum Disorder

Intervention

Behavioral:
• STEPS
behavioral counseling
• Services as usual (SAU)
behavioral counseling normally provided

Locations

Country	Name	City	State
United States	Center o=for Youth Development and Intervention	Tuscaloosa	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama, Tuscaloosa

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Transition Readiness Scale-Revised	This caregiver and self-report questionnaire has a range of possible scores from 30 to 120, with higher scores indicating greater readiness.assigned condition. Scores are categorical in nature: 0 = no evidence of progression toward goals, 1 = some evidence, 2 = strong evidence of progression toward goals.	30 days
Secondary	Relationships, Employment, Autonomy, and Life Satisfaction	This is a questionnaire completed by caregiver and participant. Higher scores indicate greater autonomy, independence, and satisfaction. On the self-report measure scores range as follows for Frequency: social engagement (0-56), outside meaningful activities (0-32), self-care (0-88), independence (0-56), and romance (0-16) and level of support ranges are: social engagement (0-68), outside meaningful activities (0-32), self-care (0-76), independence (0-48), finances (0-12), and satisfaction (0-132). On caregiver-report, frequency subscales range as follows: degree of social contact (0-28), social initiation (0-60), work/finances (0-64), autonomy (0-56), care of self and home (0-72), and support subscales range as follows: social engagement (0-68), self-care (0-144), work activity (0-28), independence (0-16), and finances (0-24).	30 days
Secondary	Rehabilitation Success	This brief interview on progress made toward educational or employment goals is completed with participant and caregiver, conducted by an examiner unaware of assigned condition. Scores are categorical in nature: 0 = no evidence of progress toward goals, 1 = some evidence of progress toward goals, 2 = moderate evidence of progress toward goals, and 3 = clear strong evidence of progress toward goals. Higher scores indicate greater goal attainment.	30 days