跳至主要内容
临床试验/NCT06941311
NCT06941311已完成不适用

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

University of Michigan2 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2025年5月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
26
试验地点
2
主要终点
Acceptability - percent of eligible youth consented

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
12 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

CBT for Suicide Prevention and the Youth-Nominated Support Team

Experimental

Participation will be 3 months.

干预措施: Cognitive Behavioral Therapy for Suicide Prevention (CBT-SP) (Behavioral)

CBT for Suicide Prevention and the Youth-Nominated Support Team

Experimental

Participation will be 3 months.

干预措施: Youth-Nominated Support Team (Behavioral)

结局指标

主要结局

Acceptability - percent of eligible youth consented

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 14 weeks

Number of CBT-SP sessions attended by youth

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Cynthia Ewell Foster

Clinical Associate Professor of Psychiatry

University of Michigan

研究点 (2)

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