About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Single group
Treatments tested in this trial
Cognitive Behavioral Therapy for Suicide Prevention (CBT-SP)
BehavioralClinicians 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-Nominated Support Team
BehavioralYouth 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
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.
Feasibility - Number of CBT-SP sessions attended
Number of CBT-SP sessions attended by youth
Sponsors and contacts
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University of Michigan
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
MiSide
Collaborator
Children's Hospital of Michigan
Collaborator