Ignite Creation Date:
2024-05-06 @ 3:23 PM
Last Modification Date:
2024-10-26 @ 1:48 PM
Study NCT ID:
NCT04612231
Status:
COMPLETED
Last Update Posted:
2023-10-19
First Post:
2020-10-22
Brief Title:
Examining the Efficacy of the T-STEP
Sponsor:
University of North Carolina Chapel Hill
Organization:
University of North Carolina Chapel Hill
Study Overview
Official Title:
Examining the Efficacy of the TEACCH School Transition to Employment and Post-Secondary Education Program
Status:
COMPLETED
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 ie 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 15 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 ie 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 eg job explorationcareer 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 explorationcareer 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
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 15 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 ie 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 eg job explorationcareer 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 explorationcareer 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDMRP-R180178-A | OTHER_GRANT | Department of Defense | None |