- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07506460
Integrating the Youth Nominated Support Team (YST) With CBT for Black Youth With Acute Suicide Risk: Aim 2b
Integrating the Youth Nominated Support Team (YST) With CBT for Black Youth With Acute Suicide Risk
This is a second pilot study being completed based on lessons learned from the Aim 2a feasibility pilot study (NCT06941311). Following modifications, the investigators are testing the acceptability, feasibility, and preliminary effectiveness of the combination of two psychosocial interventions, Cognitive Behavioral Therapy for Suicide Prevention (CBT-SP) and the computer-assisted version of the Youth-Nominated Support Team (eYST).
In this phase of the study, CBT-SP + eYST will be tested in an open trial (number of youth = 15). Investigators will recruit Black adolescents (ages 12-17) that come to an urban acute care setting for suicidal thoughts and/or self-injurious behaviors to receive the intervention in an outpatient community mental health agency. Participants will receive 12-14 sessions of CBT-SP in addition to YST. Participants will nominate up to 5 caring adults in their lives to serve as support persons. These support persons will attend an education/orientation session to learn more about their role and how to support the youth. Support persons will have weekly contact with the youth and weekly follow up contacts from the youth's clinician/YST intervention specialist.
Youth will be assessed at baseline, 6 weeks, and 14 weeks. Parents will be assessed at baseline and 14 weeks. Support persons will be assessed at baseline and 14 weeks.
Fidelity assessments will be completed by clinicians after each session, after the YST psycho-ed session, and weekly to document contact with the support team.
Study Overview
Status
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Christina Magness, LMSW
- Phone Number: 734-252-6315
- Email: cmagness@med.umich.edu
Study Locations
-
-
Michigan
-
Detroit, Michigan, United States, 48201
- Recruiting
- Children's Hospital of Michigan (CHM) Emergency Department
-
Principal Investigator:
- Curt Stankovic, MD
-
Contact:
- Christina Magness, LMSW
- Phone Number: 734-252-6315
- Email: cmagness@med.umich.edu
-
Detroit, Michigan, United States, 48210
- Recruiting
- MiSide
-
Contact:
- Christina Magness, LMSW
- Phone Number: 734-252-6315
- Email: cmagness@med.umich.edu
-
Principal Investigator:
- Marquita Felder, LMSW
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Youth Inclusion Criteria:
- Patients that are able to provide at least one verifiable contact for emergency or tracking purposes
- Willing to receive care at MiSide
- Present to an acute emergency care setting with suicide risk (per protocol)
- Self-identify as Black
- Willing and able to complete enrollment procedures
- Willing and able to provide signed and dated informed assent
Youth Exclusion Criteria:
- Unable to be consented in English
- Do not have a parent/legal guardian available to provide consent
- Are not able to provide informed assent or to participate in the assessment due to significant agitation, psychosis, cognitive impairment, learning disability, or medical trauma
- Actively engaged in specialty mental health treatment
- Participated in the Aim 2a open trial
Parent/Guardian Inclusion Criteria:
- Adults 18 years and older
- The parent or legal guardian of a youth participating in this Aim
- Understand written and spoken English
- Willing and able to complete enrollment procedures
- Willing and able to provide signed and dated informed consent
- Need to have access to technology, either cell or an email address
Parent/Guardian Exclusion Criteria:
- Do not understand written and spoken English
Support Person Inclusion Criteria:
- Adults 18 years and older
- Understand written and spoken English
- Approved to serve as a support person by the parent/legal guardian
Support Person Exclusion Criteria:
- Do not understand written and spoken English
- Not approved to serve as a support person by the parent/guardian
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: CBT for Suicide Prevention plus the Youth-Nominated Support Team
Participation will be 3 months.
|
Clinicians will provide this specialized evidence based mental health care.
The study focuses on the acute phase of CBT-SP, which is 12 sessions.
CBT-SP's goals are to reduce suicide risk factors, enhance coping, and prevent future suicidal behavior.
Identifying the emotional, cognitive, behavioral, or familial processes that precede a suicide crisis is a major focus, which yields an individualized treatment plan.
Each session lasts one hour and can be completed either in person or via a secure telehealth platform.
Most youths will attend sessions on a weekly basis and therapists will prioritize parent engagement
Youth will nominate up to 5 trusted adults.
Following parental approval, Support Persons will attend a psychoeducational orientation session with their assigned intervention specialist (i.e., the youth's clinician), learn about the youth's difficulties, treatment plan, and receive ideas for supporting the youth.
Support Persons will be asked to have contact with the youth each week for the 3 months of the study.
During these calls, Support Persons have an opportunity to discuss any questions or concerns they may have about the youth and how best to support them.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feasibility - Mean number of support people
Time Frame: 6 weeks
|
The intervention will be considered feasible if the mean number of support people per youth is at least 3.
|
6 weeks
|
|
Acceptability - Mean number of support person contacts
Time Frame: 14 weeks
|
The intervention will be considered acceptable if the mean number of support person contacts with youth is at least 7.
|
14 weeks
|
|
Feasibility - Number of CBT-SP sessions attended
Time Frame: 14 weeks
|
Number of CBT-SP sessions attended by youth
|
14 weeks
|
|
Acceptability - percent of eligible youth consented
Time Frame: Baseline
|
The intervention will be considered acceptable if at least 50% of eligible youth approached for participation choose to enroll in the study.
|
Baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Cynthia Ewell Foster, PhD, University of Michigan
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HUM00225071b
- 5R34MH131722-02 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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