Examining the Efficacy of the T-STEP

NCT04612231 | Completed

• 2 other identifiers: 19-0627CDMRP-R180178-A
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 5

Brief Summary

The objective of this study is to evaluate the TEACCH School Transition to Employment and Post-Secondary Education (T-STEP) Program. Through randomized assignment young adults (18-21 year-old) with ASD will participate in the full T-STEP Program or a counseling only condition. Effectiveness will be assessed by caregiver report (social communication, executive function, employment readiness), self-report (self-determination, coping, depression), and behavioral observation (i.e., a mock employment experience). The long-term impact of this intervention is to promote a more positive quality of life for young adults with high functioning ASD including increased postsecondary education completion, employment, self-determination, and decreased difficulties with coping and depression.

Conditions

Autism Spectrum Disorder

Keywords

Transition; High-Functioning; Social Skills; Executive Functioning; Self-Advocacy; Higher Education; Career Exploration

Outcome Measures

Primary Outcomes (5)

• Change in Becker Work Adjustment Profile-2 (BWAP) Scores from Baseline to Post-Intervention

  The BWAP is a 63-item informant report measure completed by the caregiver that evaluates skills important for job readiness and work performance across four domains: Work Habits/Attitudes, Interpersonal Relations, Cognitive Skills, and Work Performance Skills. T-Scores (27-73) for each domain will be calculated. A lower T-Score indicates more impairment on the given domain.

  Baseline, post-intervention (within 4 weeks of completing the 12-week intervention)

• Change in Behavioral Rating Inventory of Executive Function, Adult Version (BRIEF-A) Scores from Baseline to Post-Intervention

  The BRIEF-A is a 75-item informant report questionnaire that assesses a variety of behavioral manifestations of executive function (e.g., Inhibit, Self-Monitor, Plan/Organize, Shift, Initiate, Task Monitor, Emotional Control, Working Memory, and Organization of Materials) as well as a composite score of executive function. The informant report will be completed by the caregiver. T-Scores of subscales (Inhibit 39-88; Shift 38-84; Emotional Control 39-77; Self-Monitor 37-79; Initiate 36-83; Working Memory 39-90; Plan/Organize 38-83; Task Monitor 38-84; Organization of materials 37-75), Index scores (e.g., Behavioral Regulation 36-85; Metacognition 36-86) and the total score (e.g., Global Executive Composite 35-88) will be calculated. Lower T-Scores indicate higher levels of executive function and a better outcome.

  Baseline, post-intervention (within 4 weeks of completing the 12-week intervention)

• Change in Transition Readiness and Employability Evaluation (TREE) Scores from Baseline to Post-Intervention

  An objective behavioral observation measure developed that provides a series of organization, social communication, and emotion regulation presses during a simulated work environment appropriate for students with ASD and average or higher IQ. Two 15-minute employment tasks appropriate to office (e.g., filing, assembly of information folders) and computer data entry (e.g., accounting receipts, entry of evaluations forms) settings are presented. Participants have opportunities for social interaction with co-workers and supervisors, to respond to corrective feedback, and to request assistance. Assessments will be videotaped and coded by a trained research assistant who will be blind to treatment condition. Domain raw scores will be calculated (Emotion Regulation 0-16; Executive Function 0-16; Social Communication 0-22). Lower scores in each domain indicate less impairment and a better outcome.

  Baseline, post-intervention (within 4 weeks of completing the 12-week intervention)

• Change in The American Institutes for Research Self-Determination Scale (AIR) Scores from Baseline to Post-Intervention

  The AIR is a 24 item self-report measure, and an 18 item parent report of self-determination including a measure of knowledge and opportunity to modify and engage in events that affect the participant's wants and needs. The AIR's items are rated on a 5-point Likert scale. The Level of Self-Determination total raw score will be calculated for the self-report (0-120) and the parent report (0-90). A higher score indicates higher levels of self-determining behaviors and a better outcome.

  Baseline, post-intervention (within 4 weeks of completing the 12-week intervention)

• Change in Coping Self-Efficacy Scale (CES) Scores from Baseline to Post-Intervention

  The CSE is a 26-item self-report questionnaire completed by the student with ASD that measures an individual's confidence in using coping behaviors when faced with problems or life challenges. The CSE will be used to measure emotion regulation across three raw scored subscales (e.g., problem-focused coping, 0-48; stopping unpleasant emotions and thoughts, 0-36; and getting support from friends and family, 0-20) and the total raw score (0-104). A higher raw score indicates more self-confidence in an individual's ability to use coping behaviors and a better outcome.

  Baseline, post-intervention (within 4 weeks of completing the 12-week intervention)

Secondary Outcomes (11)

• Change in Center for Epidemiological Studies - Depression, Revised (CESD-R) Scores

  Up to 28 weeks

• Change in State Trait Anxiety Inventory (STAI) Trait Scale Scores

  Up to 28 weeks

• Student Adaptation to College Questionnaire (SACQ)

  4 month post-intervention completion follow up

• Change in Grade Point Average (GPA)

  Baseline, 4 month post-intervention completion follow up, a total of up to 28 weeks

• Change in Employment Status Categorizations

  Baseline, 4 month post-intervention completion follow up, a total of up to 28 weeks

Study Arms (2)

T-STEP Intervention

ACTIVE COMPARATOR

The T-STEP is a comprehensive 12-week transition program that will be delivered in a community college setting. The curriculum includes 36 hours of group-based instruction delivered within a traditional school academic semester (i.e., 24 ninety-minute classes across 12 weeks). Students also participate in a weekly community-based internship to practice the skills learned in the intervention group (2 hours per week for 12 weeks). In addition, students participate in 12 hours of manualized individual counseling services that are traditionally available on a college campus (e.g., job exploration/career counseling, academic counseling, and self-advocacy counseling).

Behavioral: TEACCH School Transition to Employment and Postsecondary Education (T-STEP)

Counseling Only Intervention

ACTIVE COMPARATOR

Participants in the Counseling Only condition will receive the same manualized counseling sessions that are included in the T-STEP program. Specifically, 12 hours of individual counseling focused on job exploration/career counseling, academic counseling, and self-advocacy counseling.

Behavioral: Counseling Services Alone

Interventions

TEACCH School Transition to Employment and Postsecondary Education (T-STEP) BEHAVIORAL

The T-STEP Program is a 12-week transition intervention targeting specific challenges that young adults with ASD experience in executive function, social communication, and emotion regulation including group intervention, internship, and counseling services

T-STEP Intervention

Counseling Services Alone BEHAVIORAL

The Counseling Services Alone Intervention will receive 12 hours of individual counseling focused on job exploration/career counseling, academic counseling, and self-advocacy counseling.

Counseling Only Intervention

Eligibility Criteria

• Age: 16 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• years old
• Has completed (or in the final year of completing) a high school diploma
• Has a previous diagnosis of ASD to be confirmed by 1) an educational diagnosis of ASD as determined by a high school IEP for autism services; and/or (2) a psychological evaluation report
• Report documenting the diagnosis of ASD within the past 5 years
• Has a minimum Full-Scale IQ score of 80 as assessed by the Wechsler Abbreviated Scale of Intelligence-II
• Has a parent or other family member/surrogate who has regular contact with the young adult who will attend the assessment visit and report on the young adult's behaviors.
• English speaking.

You may not qualify if:

• Individuals younger than 16 or older than 21 years old
• No documentation of a previous Autism diagnosis
• Has a minimum Full-Scale IQ score less than 80 as assessed by the Wechsler Abbreviated
• The young adult does not have a family member/surrogate who can report on their behaviors.
• Non-English speaking

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• United States Department of Defense: collaborator

Study Sites (5)

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

Johnston Community College

Clayton, North Carolina, 27520, United States

Location

Alamance Community College

Graham, North Carolina, 27253, United States

Location

Guilford Technical Community College

Greensboro, North Carolina, 27405, United States

Location

Wake Tech Community College

Raleigh, North Carolina, 27616, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder; Social Skills

Interventions

Counseling

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Laura Klinger, Ph.D.

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

• Brianne Tomaszewski, Ph.D.

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Research assistants will be masked to control for biases while administering the objective measure at baseline and post- assessment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The statistician will use a random number generator to assign participants to the T-STEP Intervention condition or the Counseling Only Intervention condition. Assignment will be made separately at each site and with equal numbers assigned to each condition. This will ensure that equal numbers of participants are assigned to each condition across sites per year.

Study Record Dates

• First Submitted: October 22, 2020
• First Posted: November 2, 2020
• Study Start: December 11, 2020
• Primary Completion: September 22, 2023
• Study Completion: September 22, 2023
• Last Updated: October 19, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Descriptive/raw deidentified data will be reported semi-annually through NDAR. Other experimental data will be shared after the primary objectives of the study have been met.
• Access Criteria: Request login access to NDAR data

Locations

US (5)