Suicide PreventionNCT06941311
Integrating the Youth Nominated Support Team (YST) With CBT for Black Youth With Acute Suicide Risk
A study testing Cognitive Behavioral Therapy for Suicide Prevention (CBT-SP) and Youth-Nominated Support Team in people with Suicide Prevention, run by University of Michigan at 2 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Suicide Prevention
- What is being tested?
- Cognitive Behavioral Therapy for Suicide Prevention (CBT-SP) and Youth-Nominated Support Team
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 May 2025to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Children's Hospital of Michigan (CHM) Emergency Department
Detroit, Michigan, 48201
MiSide
Detroit, Michigan, 48210
About this study
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.
- Conditions
- Suicide Prevention
- Being tested
- Cognitive Behavioral Therapy for Suicide Prevention (CBT-SP), Youth-Nominated Support Team
- Keywords
- Black youth, Acute suicide risk, Youth Nominated Support Team, Cognitive Behavioral therapy for Suicide Prevention, Community Mental Health, Suicide prevention
- Medical subject headings
- Suicide Prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Therapy for Suicide Prevention (CBT-SP)Behavioural
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-Nominated Support TeamBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| CBT for Suicide Prevention and the Youth-Nominated Support Team | Experimental | Participation will be 3 months. Receives: Behavioral: Cognitive Behavioral Therapy for Suicide Prevention (CBT-SP); Behavioral: Youth-Nominated Support Team |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability - percent of eligible youth consented
The intervention will be considered acceptable if at least 50% of eligible youth choose to enroll in the study.
Measured: 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.
Measured: 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.
Measured: 14 weeks
Feasibility - Number of CBT-SP sessions attended
Number of CBT-SP sessions attended by youth
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2025
- Study start8 May 2025
- Primary completion31 Mar 2026
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suicide PreventionStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study will recruit 6 youth and 6 parents/guardians, as well as up to 24 support individuals.
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), MiSide, Children's Hospital of Michigan
- Responsible party
- Principal investigator, Cynthia Ewell Foster, University of Michigan
- Investigators
- Cynthia Ewell Foster, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06941311
- Sponsor's protocol ID
- HUM00225071
- Other IDs
- 5R34MH131722-02
- Status last verified
- May 2026
- First submitted
- 15 Apr 2025
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upload to National Institute of Mental Health (NIMH) Data Archive.
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating the Youth Nominated Support Team (YST) With CBT for Black Youth With Acute Suicide Risk
- ClinicalTrials.gov ID
- NCT06941311
- Acronym / sponsor ID
- HUM00225071
- Conditions
- Suicide Prevention
- Keywords
- Black youth, Acute suicide risk, Youth Nominated Support Team, Cognitive Behavioral therapy for Suicide Prevention, Community Mental Health, Suicide prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), MiSide, Children's Hospital of Michigan
- Study start
- 8 May 2025 (actual)
- Primary completion
- 31 Mar 2026 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 23 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study will recruit 6 youth and 6 parents/guardians, as well as up to 24 support individuals.
| Arm | Type | Receives |
|---|---|---|
| CBT for Suicide Prevention and the Youth-Nominated Support Team | Experimental | Behavioral: Cognitive Behavioral Therapy for Suicide Prevention (CBT-SP), Behavioral: Youth-Nominated Support TeamParticipation will be 3 months. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (19 listed)
- 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
- Adults 18 years old and older
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioral Therapy for Suicide Prevention (CBT-SP)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. | Behavioural | CBT for Suicide Prevention and the Youth-Nominated Support Team |
| Youth-Nominated Support TeamYouth 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. | Behavioural | CBT for Suicide Prevention and the Youth-Nominated Support Team |
Primary outcome
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.
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.
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.
Feasibility - Number of CBT-SP sessions attended
Time frame: 14 weeks
Number of CBT-SP sessions attended by youth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Individual participant dataSharing planned: Yes. Upload to National Institute of Mental Health (NIMH) Data Archive.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cynthia Ewell Foster, PhD principal investigator
University of Michigan
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy for Suicide Prevention (CBT-SP) and Youth-Nominated Support Team in people with Suicide Prevention, run by University of Michigan at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability - percent of eligible youth consented (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.