Clinical trial NCT04612231: Examining the Efficacy of the T-STEP
Official title: Examining the Efficacy of the TEACCH School Transition to Employment and Post-Secondary Education Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: Transition
High-Functioning
Social Skills
Executive Functioning
Self-Advocacy
Higher Education
Career Exploration
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2020-11-02
Enrollment: 110
Sex: ALL
Minimum age (years): 16
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Becker Work Adjustment Profile-2 (BWAP) Scores from Baseline to Post-Intervention
timeFrame: Baseline, post-intervention (within 4 weeks of completing the 12-week intervention)
measure: Change in Behavioral Rating Inventory of Executive Function, Adult Version (BRIEF-A) Scores from Baseline to Post-Intervention
timeFrame: Baseline, post-intervention (within 4 weeks of completing the 12-week intervention)
measure: Change in Transition Readiness and Employability Evaluation (TREE) Scores from Baseline to Post-Intervention
timeFrame: Baseline, post-intervention (within 4 weeks of completing the 12-week intervention)
measure: Change in The American Institutes for Research Self-Determination Scale (AIR) Scores from Baseline to Post-Intervention
timeFrame: Baseline, post-intervention (within 4 weeks of completing the 12-week intervention)
measure: Change in Coping Self-Efficacy Scale (CES) Scores from Baseline to Post-Intervention
timeFrame: Baseline, post-intervention (within 4 weeks of completing the 12-week intervention)
Secondary outcomes:
measure: Change in Center for Epidemiological Studies - Depression, Revised (CESD-R) Scores
timeFrame: Up to 28 weeks
measure: Change in State Trait Anxiety Inventory (STAI) Trait Scale Scores
timeFrame: Up to 28 weeks
measure: Student Adaptation to College Questionnaire (SACQ)
timeFrame: 4 month post-intervention completion follow up
measure: Change in Grade Point Average (GPA)
timeFrame: Baseline, 4 month post-intervention completion follow up, a total of up to 28 weeks
measure: Change in Employment Status Categorizations
timeFrame: Baseline, 4 month post-intervention completion follow up, a total of up to 28 weeks
measure: Change in Becker Work Adjustment Profile-2 (BWAP) Scores from Post-Intervention to 4 Month Follow Up
timeFrame: Post-Intervention (within 4 weeks of completing the 12-week intervention), 4 month post-intervention completion follow up, a total of up to 16 weeks
measure: Change in Behavioral Rating Inventory of Executive Function, Adult Version (BRIEF-A) Scores from Post-Intervention to 4 Month Follow Up
timeFrame: Post-Intervention (within 4 weeks of completing the 12-week intervention), 4 month post-intervention completion follow up, a total of up to 16 weeks
measure: Change in The American Institutes for Research Self-Determination Scale (AIR) Scores from Post-Intervention to 4 Month Follow Up
timeFrame: Post-Intervention (within 4 weeks of completing the 12-week intervention), 4 month post-intervention completion follow up, a total of up to 16 weeks
measure: Change in Coping Self-Efficacy Scale (CES) Scores from Post-Intervention to 4 Month Follow Up
timeFrame: Post-Intervention (within 4 weeks of completing the 12-week intervention), 4 month post-intervention completion follow up, a total of up to 16 weeks
measure: Change in Activities of Daily Living (WADL) Scores
timeFrame: Up to 28 weeks
measure: Change in Clinical Global Impression Scale (CGI) Scores from Baseline to Post-Intervention
timeFrame: Baseline, post-intervention (within 4 weeks of completing the 12-week intervention)
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Clayton
country: United States
facility: Johnston Community College
state: North Carolina
city: Graham
country: United States
facility: Alamance Community College
state: North Carolina
city: Greensboro
country: United States
facility: Guilford Technical Community College
state: North Carolina
city: Raleigh
country: United States
facility: Wake Tech Community College
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Laura Klinger, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of North Carolina, Chapel Hill
name: Brianne Tomaszewski, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: