Examining the Efficacy of the T-STEP

NCT ID: NCT04612231

Last Updated: 2023-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-11

Study Completion Date

2023-09-22

Brief Summary

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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.

Detailed Description

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The purpose of the proposed study is to conduct an alternative treatment randomized clinical trial (RCT) to examine the efficacy of the TEACCH School Transition to Employment and Postsecondary Education (T-STEP) Program, 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, compared to counseling services only. The investigator predicts that the full T-STEP program (community college course, internship, counseling) will lead to improved short-term and long-term outcomes compared to counseling services only.

One cohort will be conducted per semester at two different community colleges with the specific semester counterbalanced across years. Each site will run one to two cohorts per year. The study will be conducted for three years. Students will be enrolled in the study after screening inclusion criteria have been met.

1. Screening. After contact, initial eligibility criteria will be confirmed during a phone screening documenting age, previous diagnosis of ASD, and completion, or in the final year of completing, a high school diploma.
2. Pre-Assessment. Young adults and caregivers will complete an assessment at their regional community college or via video visit (depending on COVID-19 restrictions) to verify eligibility. Following verification students will be randomized to the T-STEP Comprehensive intervention or the Counseling Only intervention.

The statistician will use a random number generator to assign participants to the T-STEP Comprehensive intervention condition or the Counseling Only condition. The statistical consultant will use a random number generator to assign participants to the T-STEP Comprehensive intervention condition or the Counseling Only 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.
3. Baseline. Baseline assessments are estimated to take 2 hours (1 hour for behavioral measures; 1 hour for self-report paper and pencil measures). Caregiver measures are estimated to take 1 to 1.5 hours. Assessments will take place on the community college campus or via video visit (depending on COVID-19 restrictions).
4. Intervention. Both treatment conditions will be offered free of charge through our partnership with participating community colleges. Participants in both groups will complete 12-weeks of treatment as described below. All sessions will occur at regional community college campuses via video sessions, or via a hybrid approach with some sessions virtually and some sessions on campus (depending on COVID-19 restrictions).

T-STEP Intervention Condition. 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).

Counseling Only Intervention Condition. Participants in the Counseling Only condition will receive the same manualized counseling sessions that are included in the T-STEP program described above. Specifically, 12 hours of individual counseling focused on job exploration/career counseling, academic counseling, and self-advocacy counseling.
5. Post-Intervention (Post-Test) \& Follow-Up. Participants in both conditions will complete post-assessments immediately following treatment and a follow-up assessment 4 months (week 28) after finishing the treatment. All assessments will take place on the community college campus or via video visit (depending on COVID-19 restrictions). Both assessments will take approximately 2 hours to complete by students with ASD and 35 minutes to complete by caregivers. Assessments will be completed by research assistants who are unfamiliar to participants.

Conditions

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Autism Spectrum Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Research assistants will be masked to control for biases while administering the objective measure at baseline and post- assessment.

Study Groups

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T-STEP Intervention

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).

Group Type ACTIVE_COMPARATOR

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

Intervention Type 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

Counseling Only Intervention

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.

Group Type ACTIVE_COMPARATOR

Counseling Services Alone

Intervention Type 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.

Interventions

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

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

Intervention Type BEHAVIORAL

Counseling Services Alone

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 16-21 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.

Exclusion Criteria

* 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
Minimum Eligible Age

16 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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United States Department of Defense

FED

Sponsor Role collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Laura Klinger, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Brianne Tomaszewski, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

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University of North Carolina

Chapel Hill, North Carolina, United States

Site Status

Johnston Community College

Clayton, North Carolina, United States

Site Status

Alamance Community College

Graham, North Carolina, United States

Site Status

Guilford Technical Community College

Greensboro, North Carolina, United States

Site Status

Wake Tech Community College

Raleigh, North Carolina, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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CDMRP-R180178-A

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

19-0627

Identifier Type: -

Identifier Source: org_study_id

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