Autism Spectrum DisorderNCT04612231

Examining the Efficacy of the T-STEP

A study testing TEACCH School Transition to Employment and Postsecondary Education (T-STEP) and Counseling Services Alone in people with Autism Spectrum Disorder, run by University of North Carolina, Chapel Hill at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 16 to 21 years
Conditions the study is for: Autism Spectrum Disorder
What is being tested?: TEACCH School Transition to Employment and Postsecondary Education (T-STEP) and Counseling Services Alone
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 110 participants
Where: 5 sitesUnited States
Study dates: 11 Dec 2020to 22 Sep 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 16 to 21 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

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.

Who cannot join

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 locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

University of North Carolina
Chapel Hill, North Carolina, 27599
Johnston Community College
Clayton, North Carolina, 27520
Alamance Community College
Graham, North Carolina, 27253
Guilford Technical Community College
Greensboro, North Carolina, 27405
Wake Tech Community College
Raleigh, North Carolina, 27616

Other trials in United States

About this study

Official title: Examining the Efficacy of the TEACCH School Transition to Employment and Post-Secondary Education Program

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.

Read the 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.

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.
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.
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).
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.
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: Autism Spectrum Disorder
Being tested: TEACCH School Transition to Employment and Postsecondary Education (T-STEP), Counseling Services Alone
Keywords: Transition, High-Functioning, Social Skills, Executive Functioning, Self-Advocacy, Higher Education, Career Exploration
Medical subject headings: Autism Spectrum Disorder, Social Skills

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TEACCH School Transition to Employment and Postsecondary Education (T-STEP)Behavioural
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 Services AloneBehavioural
The Counseling Services Alone Intervention will receive 12 hours of individual counseling focused on job exploration/career counseling, academic counseling, and self-advocacy counseling.

Study groups in NCT04612231
Study group	Role	What they receive
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). Receives: 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. Receives: Behavioral: Counseling Services Alone

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
The 20-item self-report version of the CESD-R, completed by the student with ASD, will be used to assess symptoms of depression. Respondents are asked to answer each question using a 4-point Likert scale from "less than one day" to "5-7 days" to describe their feelings (e.g., "I felt sad.") during the past week. The Total CESD-R Score will be calculated as a sum of responses to all 20 questions (0-60). A lower score indicates less depressive symptoms and a better outcome. Assessed at Baseline, post-intervention, and 4 month follow up.
Measured: Up to 28 weeks
Change in State Trait Anxiety Inventory (STAI) Trait Scale Scores
A 20-item self-report completed by the student with ASD used to assess symptoms of anxiety. Respondents are asked to answer each question using a 4-point Likert scale from "almost never" to "almost always." The total score (20-80) will be used as a moderator of intervention efficacy and as an immediate outcome. A low score indicates less impairment of general anxiety and a better outcome. Assessed at Baseline, post-intervention, and 4 month follow up.
Measured: Up to 28 weeks
Student Adaptation to College Questionnaire (SACQ)
The SACQ is a self-report measure completed by the student with ASD of adjustment to college in four areas: Academic Adjustment, Social Adjustment, Personal-Emotional Adjustment, and Institutional Attachment. T-Scores will be calculated for the four domains and the total score (25-75). Conversion tables are categorized by gender and year in college. Higher scores indicates better adjustment to college and a better outcome.
Measured: 4 month post-intervention completion follow up
Change in Grade Point Average (GPA)
GPA will be collected to measure change in success following completion of the intervention. Better outcomes are indicated by increased GPA.
Measured: Baseline, 4 month post-intervention completion follow up, a total of up to 28 weeks
Change in Employment Status Categorizations
Employment status will be measured through quantitative categorizations of employment wages (e.g., under minimum wage, minimum wage, above minimum wage, unpaid volunteer; 1-4) and number of hours worked per week (e.g., less than 5 hours, 5-9 hours, 10-19 hours, 20-29 hours, 30-29 hours, 40 hours; 1-6). Maintenance or increase of employment wages and number of hours worked per week is a better outcome.
Measured: Baseline, 4 month post-intervention completion follow up, a total of up to 28 weeks
Change in Becker Work Adjustment Profile-2 (BWAP) Scores from Post-Intervention to 4 Month Follow Up
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.
Measured: 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
Change in Behavioral Rating Inventory of Executive Function, Adult Version (BRIEF-A) Scores from Post-Intervention to 4 Month Follow Up
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.
Measured: 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
Change in The American Institutes for Research Self-Determination Scale (AIR) Scores from Post-Intervention to 4 Month Follow Up
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.
Measured: 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
Change in Coping Self-Efficacy Scale (CES) Scores from Post-Intervention to 4 Month Follow Up
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.
Measured: 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
Change in Activities of Daily Living (WADL) Scores
The WADL is a 17-item informant report questionnaire that assesses current levels of independence in performing activities of daily living. Respondents are asked to answer each question using a 3-point Likert scale from "does not do at all" to "independent/does on own" to describe the person's level of independence. The Total WADL Score will be calculated as a sum of responses to all 17 questions (0-34). A higher score indicates more independence and a better outcome. Assessed at Baseline, post-intervention, and 4-month follow-up.
Measured: Up to 28 weeks
Change in Clinical Global Impression Scale (CGI) Scores from Baseline to Post-Intervention
The CGI is completed by the interventionist and assesses transition readiness on a 7-point scale. Higher scores correspond to better transition readiness.
Measured: Baseline, post-intervention (within 4 weeks of completing the 12-week intervention)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Dec 202022 Sep 2023

First posted2 Nov 2020
Study start11 Dec 2020
Primary completion22 Sep 2023
Study completion22 Sep 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
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.
Masking: None (open label)
Enrolment: 110 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04612231
Sponsor's protocol ID: 19-0627
Other IDs: CDMRP-R180178-A
Status last verified: Oct 2023
First submitted: 22 Oct 2020
Last updated: 19 Oct 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Deidentified individual data that supports the results will be shared via the National Database for Autism Research (NDAR). In addition, an NDAR study for each publication that underlies results of the study will be created so that readers of the article can link back to the data used in NDAR.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 19 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Examining the Efficacy of the TEACCH School Transition to Employment and Post-Secondary Education Program
ClinicalTrials.gov ID: NCT04612231
Acronym / sponsor ID: 19-0627
Conditions: Autism Spectrum Disorder
Keywords: Transition, High-Functioning, Social Skills, Executive Functioning, Self-Advocacy, Higher Education, Career Exploration
Study type: Interventional
Recruitment status: Completed
Enrolment: 110 participants (actual)
Lead sponsor: University of North Carolina, Chapel HillUniversity, hospital or other
Collaborators: United States Department of Defense
Study start: 11 Dec 2020 (actual)
Primary completion: 22 Sep 2023 (actual)
Study completion: 22 Sep 2023 (actual)
First posted: 2 Nov 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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.
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.
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).
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.
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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
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.

Arm	Type	Receives
T-STEP Intervention	Active comparator	Behavioral: TEACCH School Transition to Employment and Postsecondary Education (T-STEP)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	Active comparator	Behavioral: Counseling Services AloneParticipants 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.

Who may qualify

Ages: 16 to 21 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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	Behavioural	T-STEP Intervention
Counseling Services AloneThe Counseling Services Alone Intervention will receive 12 hours of individual counseling focused on job exploration/career counseling, academic counseling, and self-advocacy counseling.	Behavioural	Counseling Only Intervention

Primary outcome

Change in Becker Work Adjustment Profile-2 (BWAP) Scores from Baseline to Post-Intervention
Time frame: Baseline, post-intervention (within 4 weeks of completing the 12-week 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.
Change in Behavioral Rating Inventory of Executive Function, Adult Version (BRIEF-A) Scores from Baseline to Post-Intervention
Time frame: Baseline, post-intervention (within 4 weeks of completing the 12-week 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.
Change in Transition Readiness and Employability Evaluation (TREE) Scores from Baseline to Post-Intervention
Time frame: Baseline, post-intervention (within 4 weeks of completing the 12-week 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.
Change in The American Institutes for Research Self-Determination Scale (AIR) Scores from Baseline to Post-Intervention
Time frame: Baseline, post-intervention (within 4 weeks of completing the 12-week 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.
Change in Coping Self-Efficacy Scale (CES) Scores from Baseline to Post-Intervention
Time frame: Baseline, post-intervention (within 4 weeks of completing the 12-week 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.

11 secondary outcomes

Change in Center for Epidemiological Studies - Depression, Revised (CESD-R) Scores
Time frame: Up to 28 weeks
Change in State Trait Anxiety Inventory (STAI) Trait Scale Scores
Time frame: Up to 28 weeks
Student Adaptation to College Questionnaire (SACQ)
Time frame: 4 month post-intervention completion follow up
Change in Grade Point Average (GPA)
Time frame: Baseline, 4 month post-intervention completion follow up, a total of up to 28 weeks
Change in Employment Status Categorizations
Time frame: Baseline, 4 month post-intervention completion follow up, a total of up to 28 weeks
Change in Becker Work Adjustment Profile-2 (BWAP) Scores from Post-Intervention to 4 Month Follow Up
Time frame: 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
Change in Behavioral Rating Inventory of Executive Function, Adult Version (BRIEF-A) Scores from Post-Intervention to 4 Month Follow Up
Time frame: 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
Change in The American Institutes for Research Self-Determination Scale (AIR) Scores from Post-Intervention to 4 Month Follow Up
Time frame: 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
Change in Coping Self-Efficacy Scale (CES) Scores from Post-Intervention to 4 Month Follow Up
Time frame: 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
Change in Activities of Daily Living (WADL) Scores
Time frame: Up to 28 weeks
Change in Clinical Global Impression Scale (CGI) Scores from Baseline to Post-Intervention
Time frame: Baseline, post-intervention (within 4 weeks of completing the 12-week intervention)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2023.
Individual participant dataSharing planned: Yes. Deidentified individual data that supports the results will be shared via the National Database for Autism Research (NDAR). In addition, an NDAR study for each publication that underlies results of the study will be created so that readers of the article can link back to the data used in NDAR.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Laura Klinger, Ph.D. principal investigator

University of North Carolina, Chapel Hill

Brianne Tomaszewski, Ph.D. principal investigator

University of North Carolina, Chapel Hill

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Becker Work Adjustment Profile-2 (BWAP) Scores from Baseline to Post-Intervention (time frame: Baseline, post-intervention (within 4 weeks of completing the 12-week intervention)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04612231.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2023.