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RecruitingNCT05695885Updated Aug 16, 2024

STEPS Implementation Trial

An interventional study of STEPS and Services as usual (SAU) in Autism Spectrum Disorder, sponsored by University of Alabama, Tuscaloosa. Recruiting at 1 site in United States. Open to participants aged 16 Years to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-16.

Sponsored by University of Alabama, Tuscaloosa · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
16 Years to 25 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Autism Spectrum Disorder

Keywords

  • transition
  • adulthood
  • employment
  • education
03

Who can participate

Ages eligible
16 Years to 25 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • presence of suicidal/homicidal intent
04

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    STEPS

    14 session counseling targeting adult independence skills

    Behavioral: STEPS

  • Other
    Control

    Services as usual

    Behavioral: Services as usual (SAU)

Interventions

  • BehavioralSTEPS

    behavioral counseling

  • BehavioralServices as usual (SAU)

    behavioral counseling normally provided

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 30 days

Secondary outcomes

  1. 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).

    Time frame: 30 days

  2. 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.

    Time frame: 30 days

06

Study locations

1 of 1 sites recruiting
  • Center o=for Youth Development and Intervention
    Tuscaloosa, Alabama 35487, United States
    Recruiting
07

References and documents

Individual participant data

Plan to share: Yes — we submit de-identified data to NIH repository (NDA)

Supporting information: Study protocol

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT05695885
Lead sponsor
University of Alabama, Tuscaloosa
Responsible party
Susan White (Professor, University of Alabama, Tuscaloosa) — Principal investigator
First posted
Jan 25, 2023
Start date
Apr 1, 2023
Primary completion
Mar 31, 2025 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Aug 16, 2024

Study contacts

Susan W White, PhD
Contact
swwhite1@ua.edu
2053481967
Nicole Powell, PHD
Contact
npowell@ua.edu
2053483535

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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