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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
University of Alabama, Tuscaloosa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Autism Spectrum Disorder focused on measuring transition, adulthood, employment, education

Eligibility Criteria

16 Years - 25 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    January 13, 2023
    Last Updated
    January 27, 2023
    Sponsor
    University of Alabama, Tuscaloosa
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    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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