Integrating the Youth Nominated Support Team (YST) With CBT for Black Youth With Acute Suicide Risk: Aim 2b

NCT07506460 | Recruiting DMC

• 2 other identifiers: HUM00225071b5R34MH131722-02
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Suicide Prevention; Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Keywords

Black youth; Acute suicide risk; Youth Nominated Support Team; Cognitive Behavioral therapy for Suicide Prevention; Community Mental Health; Suicide prevention; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Cognitive Behavioral Therapy

Outcome Measures

Primary Outcomes (4)

• Acceptability - percent of eligible youth consented

  The intervention will be considered acceptable if at least 50% of eligible youth approached for participation choose to enroll in the study.

  Baseline

• Feasibility - Mean number of support people

  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

  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

  Number of CBT-SP sessions attended by youth

  14 weeks

Study Arms (1)

CBT for Suicide Prevention plus the Youth-Nominated Support Team

EXPERIMENTAL

Participation will be 3 months.

Behavioral: Cognitive Behavioral Therapy for Suicide Prevention (CBT-SP); Behavioral: Youth-Nominated Support Team

Interventions

Cognitive Behavioral Therapy for Suicide Prevention (CBT-SP) BEHAVIORAL

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

CBT for Suicide Prevention plus the Youth-Nominated Support Team

Youth-Nominated Support Team BEHAVIORAL

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.

CBT for Suicide Prevention plus the Youth-Nominated Support Team

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• \- Do not understand written and spoken English
• Adults 18 years and older
• Understand written and spoken English
• Approved to serve as a support person by the parent/legal guardian

Sponsors & Collaborators

• University of Michigan: lead
• National Institute of Mental Health (NIMH): collaborator
• MiSide: collaborator
• Children's Hospital of Michigan: collaborator

Study Sites (2)

Children's Hospital of Michigan (CHM) Emergency Department

Detroit, Michigan, 48201, United States

RECRUITING

MiSide

Detroit, Michigan, 48210, United States

RECRUITING

MeSH Terms

Conditions

Suicide Prevention; Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior; Motor Activity

Interventions

Cognitive Behavioral Therapy

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Cynthia Ewell Foster, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christina Magness, LMSW

CONTACT

734-252-6315; cmagness@med.umich.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: This study will recruit 15 youth and 15 parents/guardians, as well as up to 60 support individuals.

Study Record Dates

• First Submitted: March 26, 2026
• First Posted: April 1, 2026
• Study Start: March 23, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: After the study is completed and available according to NIMH Data Archive policy.
• Access Criteria: Researchers can request de-identified data from the study contacts listed in the study.

Locations

US (2)