STEPS Implementation Trial
Primary Purpose
Autism Spectrum Disorder
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
STEPS
Services as usual (SAU)
Sponsored by
About this trial
This is an interventional health services research trial for Autism Spectrum Disorder focused on measuring transition, adulthood, employment, education
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
STEPS
Control
Arm Description
14 session counseling targeting adult independence skills
Services as usual
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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).
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.
Full Information
NCT ID
NCT05695885
First Posted
January 13, 2023
Last Updated
January 27, 2023
Sponsor
University of Alabama, Tuscaloosa
1. Study Identification
Unique Protocol Identification Number
NCT05695885
Brief Title
STEPS Implementation Trial
Official Title
Stepped Transition in Education Program for Emerging Adults With Autism: Pilot Effectiveness Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 1, 2023 (Anticipated)
Primary Completion Date
April 1, 2025 (Anticipated)
Study Completion Date
December 6, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama, Tuscaloosa
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
Keywords
transition, adulthood, employment, education
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel RCT
Masking
Outcomes Assessor
Masking Description
The main outcome measure is completed by a trained evaluator unaware of assigned treatment condition (i.e., the Independent Evaluator; IE).
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
STEPS
Arm Type
Experimental
Arm Description
14 session counseling targeting adult independence skills
Arm Title
Control
Arm Type
Other
Arm Description
Services as usual
Intervention Type
Behavioral
Intervention Name(s)
STEPS
Intervention Description
behavioral counseling
Intervention Type
Behavioral
Intervention Name(s)
Services as usual (SAU)
Intervention Description
behavioral counseling normally provided
Primary Outcome Measure Information:
Title
Transition Readiness Scale-Revised
Description
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 Outcome Measure Information:
Title
Relationships, Employment, Autonomy, and Life Satisfaction
Description
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
Title
Rehabilitation Success
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Susan W White, PhD
Phone
2053481967
Email
swwhite1@ua.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Nicole Powell, PHD
Phone
2053483535
Email
npowell@ua.edu
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
we submit de-identified data to NIH repository (NDA)
IPD Sharing Time Frame
one year after study closure
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STEPS Implementation Trial
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