Integrating the Youth Nominated Support Team (YST) With CBT for Black Youth With Acute Suicide Risk
The investigators are modifying and testing the preliminary effectiveness and implementation 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). This registration will be for Aim 2 and a pilot randomized clinical trial for Aim 3 will be registered separately.
In this phase of the study, CBT-SP+eYST will be tested in an initial open trial (number of youth=6) to examine its feasibility and acceptability. Investigators will recruit Black adolescents that come to an urban emergency department (ED) for suicidal thoughts and/or behaviors to receive the intervention in an outpatient community mental health agency. The study focuses on the acute phase of CBT-SP, which is 12 sessions. Participants will nominate up to 4 caring adults in the participants 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.
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 CBT-SP session, after the YST psycho-ed session, and weekly to document contact with the support team.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Michigan
-
Detroit, Michigan, United States, 48201
- Children's Hospital of Michigan (CHM) Emergency Department
-
Detroit, Michigan, United States, 48210
- MiSide
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion criteria for youth:
- Patients of any gender between the ages of 12 and 17 years
- Patients that are able to provide at least one verifiable contact for emergency or tracking purposes
- Eligible for care at MiSide
- Present to the ED with suicide risk (per protocol)
- Self-identify as Black (obtain from face sheet collected in triage)
- Willing and able to complete enrollment procedures
- Willing and able to provide signed and dated informed assent
Exclusion criteria for youth:
- 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
Parent/Guardian Inclusion Criteria:
- Adults 18 years old and older
- The parent or legal guardian of a youth participating in Aim 2
- Understand written and spoken English
- Willing and able to complete enrollment procedures
- Willing and able to provide signed and dated informed consent
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 and 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 typically like to be in contact with parents as well.
Youth will nominate up to 4 trusted adults.
Following parental approval, Support Persons will attend an orientation session with their assigned intervention specialist, 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 up to three months to offer emotional support, encourage participation in treatment, and support the youth's healthy behaviors.
Support Persons will have weekly check-ins with their intervention specialist every 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 |
|---|---|---|
|
Acceptability - percent of eligible youth consented
Time Frame: Baseline
|
The intervention will be considered acceptable if at least 50% of eligible youth choose to enroll in the study.
|
Baseline
|
|
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
|
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 (Actual)
Study Completion (Actual)
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
- HUM00225071
- 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
product manufactured in and exported from the U.S.
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.