Clinical trial NCT06941311: Integrating the Youth Nominated Support Team (YST) With CBT for Black Youth With Acute Suicide Risk
Official title: Integrating the Youth Nominated Support Team (YST) With CBT for Black Youth With Acute Suicide Risk
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Suicide Prevention
Keywords: Black youth
Acute suicide risk
Youth Nominated Support Team
Cognitive Behavioral therapy for Suicide Prevention
Community Mental Health
Suicide prevention
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: MiSide
name: Children's Hospital of Michigan
First posted: 2025-04-23
Enrollment: 36
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This study will recruit 6 youth and 6 parents/guardians, as well as up to 24 support individuals.
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Acceptability - percent of eligible youth consented
timeFrame: Baseline
measure: Feasibility - Mean number of support people
timeFrame: 6 weeks
measure: Acceptability - Mean number of support person contacts
timeFrame: 14 weeks
measure: Feasibility - Number of CBT-SP sessions attended
timeFrame: 14 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Children's Hospital of Michigan (CHM) Emergency Department
state: Michigan
city: Detroit
country: United States
facility: MiSide
state: Michigan
Study officials:
affiliation: University of Michigan
name: Cynthia Ewell Foster, PhD
role: PRINCIPAL_INVESTIGATOR
References: