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临床试验/NCT07401940
NCT07401940招募中不适用

A Multi-Generational Suicide Prevention Program in African American Churches

George Washington University2 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2023年6月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
240
试验地点
2
主要终点
Kiddie-Computerized Adaptive Testing for Mental Disorders

研究概览

简要总结

HAVEN=CONNECT is a comprehensive depression and suicide prevention intervention that is designed to be integrated into predominantly Black churches, a strategically ideal location for mental health intervention for Black youth. HAVEN=CONNECT has three components: (1) Church Community Engagement: an interactive process of introducing the program to key church leaders and stakeholder groups. (2) Faith-Based Curriculum: educational overview for pastors, other ministerial staff and youth lay leaders on how to integrate the program into the church using communication mediums that have cultural and religious relevance in the Black Church context. (3) Youth-Connect Intervention: The goals of this project are to test the impact of HAVEN=CONNECT (HAVEN) on key intervention targets, hypothesized mediators, and build a research-informed implementation strategy for future large-scale testing.

详细描述

Aim 1: Efficacy. The investigators will implement HAVEN in 12 churches using a cluster randomized waitlist design and enroll 240 adolescents (ages 13-19). The investigators hypothesize that adolescents in HAVEN churches vs. those in wait-listed churches will have decreased depression symptoms (primary outcome) and suicide risk scores at 1-month and 6-month follow-up after the start of the multi-component HAVEN. Suicide risk will be a secondary outcome due to lower expected statistical power to detect impact vs. depression. The investigators also expect HAVEN to decrease other mental health symptoms that are secondary outcomes (e.g., anxiety). The investigators will test for differences by gender, age, and level of depression and suicide risk at baseline.

Aim 2: Mechanisms. The second aim is to test hypothesized mediators of HAVEN impact. It is hypothesized that HAVEN will increase (a) adolescents' positive bonds to peers and adults in their church, perceptions of cohesion, and healthy norms in those networks; (b) emotional and behavior self-regulation, and (c) increased use of mental health services (H1). HAVEN impact on reducing depression and suicide risk will be mediated by those changes (H2).

Aim 3: Implementation. The investigators will identify implementation barriers and facilitators by examining adherence data (i.e., completion of HAVEN steps and clergy/member engagement) and then gathering qualitative data from a subset of 4 churches, 2 identified as implementing HAVEN with high adherence and 2 with lower adherence. This aim involves semi-structured key informant interviews. The investigators will also train church and community members as HAVEN=CONNECT co-trainers, assess their fidelity of training using existing fidelity measures, as part of this aim on identifying strategies for sustaining HAVEN after the end of the grant period and for scalability.

Primary outcome variable for Youth: Suicide risk & depression Secondary outcome variable for Youth: Anxiety Mediators for Youth: mental health service use, emotion regulation skills, stressful life events, adolescent experiences with discrimination, peer networks, help-seeking acceptability, group cohesion, healthy peer norms and behaviors, trusted adult networks, Helpfulness of Adults with emotions, positive communication with parents, demographic information.

Adult mediators: satisfaction with training, retention of skills, intention to use skills in personal life and with youth, adoption of skills, experience engaging youth with skills, and adult peer network.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
13 Years 至 19 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • For churches:
  • 75% of members self-identify as Black or African American,
  • 75% are fluent in English.

排除标准

  • self-identify as Black/African American,
  • 13-19 years old, are fluent in English
  • Exclusion Criteria: Churches:
  • 25%+ of members self-identify as non-Black or African American
  • 25%+ are not fluent in English.
  • Exclusion Criteria for Youth:
  • do not self-identify as Black/African American,
  • are younger than 13 or older than 19.

研究组 & 干预措施

HAVEN Intervention Group

Experimental

Participants receive HAVEN Connect intervention

干预措施: HAVEN-Connect (Behavioral)

HAVEN Wait List Control Group

Placebo Comparator

On 6-month wait list where they only receive text messages

干预措施: HAVEN Suicide Prevention (Behavioral)

结局指标

主要结局

Kiddie-Computerized Adaptive Testing for Mental Disorders

时间窗: baseline, 1- and 6-month followup

Measures depressive symptoms and suicide risk; it asks fewer questions than traditional suicide screeners because it is response adaptive. Instead of fixing the items and allowing the precision of measurement to vary, the authors fix the precision of measurement and allow the items to vary. The K-CAT adaptively selects a small set of items from a large item-bank of 2,120 items, using a 4-point Likert scale (Strongly Agree, Agree, Disagree, Strongly Disagree). The results yield four metrics: 1) a severity score ranging from 0 - 100, with 0 representing the lowest severity, and 100 representing the highest severity. The prompt for each question is: "In the past two weeks..." Sample items include: "I felt worthless" I felt everyone would be better off without me" .

次要结局

  • Kiddie-Computerized Adaptive Testing for Mental Disorders.(baseline, 1- and 6-month followup)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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