NCT05581069

Brief Summary

The goal of this study is to conduct the first community-based implementation of the STEPS program and test feasibility and preliminary impact. After first working with stakeholders to refine and optimize the program we will launch a Hybrid Type 1 open trial, targeting 25 transition-age youth (TAY) with ASD.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 15, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 29, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

October 14, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
Last Updated

November 30, 2023

Status Verified

November 1, 2023

Enrollment Period

2 years

First QC Date

September 29, 2022

Last Update Submit

November 29, 2023

Conditions

Keywords

autismadulttransitionemployment

Outcome Measures

Primary Outcomes (2)

  • Adult Functioning Scale

    The Adult Functioning Scale measures autonomy, employment (including readiness), social functioning, and satisfaction via self- and informant-report questionnaires

    Week 14

  • Rehabilitation Success

    This is completed via interview to assess 'real world' vocational engagement

    Week 14

Study Arms (1)

STEPS

EXPERIMENTAL

All participants receive the STEPS intervention

Behavioral: STEPS

Interventions

STEPSBEHAVIORAL

STEPS is a psychosocial intervention that targets self-determination, self-regulation, and self-knowledge to improve functional independence and quality of life in adults.

STEPS

Eligibility Criteria

Age16 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • ages 16-25 confirmed diagnosis of ASD caregiver willing to participate stable medication

You may not qualify if:

  • evidence of intellectual disability evidence of suicidal intent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Youth Development and Intervention

Tuscaloosa, Alabama, 35487, United States

RECRUITING

Related Publications (3)

  • White SW, Smith IC, Miyazaki Y, Conner CM, Elias R, Capriola-Hall NN. Improving Transition to Adulthood for Students with Autism: A Randomized Controlled Trial of STEPS. J Clin Child Adolesc Psychol. 2021 Mar-Apr;50(2):187-201. doi: 10.1080/15374416.2019.1669157. Epub 2019 Oct 14.

    PMID: 31609666BACKGROUND
  • Elias R, White SW. Autism Goes to College: Understanding the Needs of a Student Population on the Rise. J Autism Dev Disord. 2018 Mar;48(3):732-746. doi: 10.1007/s10803-017-3075-7.

    PMID: 28255760BACKGROUND
  • White SW, Elias R, Capriola-Hall NN, Smith IC, Conner CM, Asselin SB, Howlin P, Getzel EE, Mazefsky CA. Development of a College Transition and Support Program for Students with Autism Spectrum Disorder. J Autism Dev Disord. 2017 Oct;47(10):3072-3078. doi: 10.1007/s10803-017-3236-8.

    PMID: 28685409BACKGROUND

MeSH Terms

Conditions

Autism Spectrum DisorderAutistic Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Susan W White

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Susan W White

CONTACT

Nicole Powell

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
The assessment battery is multi-modal and includes evaluation by an independent evaluator (IE) who is uninvolved in STEPS delivery or training.
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: This is a single-arm (non-randomized) trial in which providers are community-based practitioners.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2022

First Posted

October 14, 2022

Study Start

May 15, 2022

Primary Completion

May 1, 2024

Study Completion

August 1, 2024

Last Updated

November 30, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

There is no pre-existing plan, but de-identified data will be shared after publication of main findings, upon request.

Locations