STEPS Implementation Trial

NCT05695885 | Recruiting DMC

• 1 other identifier: 22-07-5746
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder

Keywords

transition; adulthood; employment; education

Outcome Measures

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.

  30 days

Secondary Outcomes (2)

• Relationships, Employment, Autonomy, and Life Satisfaction

  30 days

• Rehabilitation Success

  30 days

Study Arms (2)

STEPS

EXPERIMENTAL

14 session counseling targeting adult independence skills

Behavioral: STEPS

Control

OTHER

Services as usual

Behavioral: Services as usual (SAU)

Interventions

STEPS BEHAVIORAL

behavioral counseling

STEPS

Services as usual (SAU) BEHAVIORAL

behavioral counseling normally provided

Control

Eligibility Criteria

• Age: 16 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• years of age
• have confirmed diagnosis of ASD
• want to participate in STEPS
• have a caregiver/parent who can complete assessments

You may not qualify if:

• presence of suicidal/homicidal intent

Sponsors & Collaborators

• University of Alabama, Tuscaloosa: lead

Study Sites (1)

Center o=for Youth Development and Intervention

Tuscaloosa, Alabama, 35487, United States

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Central Study Contacts

Susan W White, PhD

CONTACT

2053481967; swwhite1@ua.edu

Nicole Powell, PHD

CONTACT

2053483535; npowell@ua.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The main outcome measure is completed by a trained evaluator unaware of assigned treatment condition (i.e., the Independent Evaluator; IE).
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Parallel RCT

Study Record Dates

• First Submitted: January 13, 2023
• First Posted: January 25, 2023
• Study Start: April 1, 2023
• Primary Completion: March 31, 2025
• Study Completion: December 31, 2025
• Last Updated: August 16, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: one year after study closure

Locations

US (1)