Examining the Efficacy of the T-STEP

University of North Carolina (UNC)

Status: Completed

Conditions: Autism Spectrum Disorder

Treatments: Behavioral: TEACCH School Transition to Employment and Postsecondary Education (T-STEP); Behavioral: Counseling Services Alone

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT04612231

19-0627

CDMRP-R180178-A (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 110 patients

Sex: All

Ages: 16 to 21 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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110 participants in 2 patient groups

T-STEP Intervention

Active Comparator group

Description:

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).

Treatment:

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

Counseling Only Intervention

Active Comparator group

Description:

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.

Treatment:

Behavioral: Counseling Services Alone