HAVEN-Connect Youth Suicide Prevention

Официальное название

A Multi-Generational Suicide Prevention Program in African American Churches

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое HAVEN-Connect
  Youth-Connect Program for adolescents/emerging adults and Connect training for adult members is a strength-based network health depression and suicide prevention program. Participants learn together about and model skills to each other to grow and sustain "Four Cores" supportive of mental health and reduced likelihood of vulnerability to suicidal thoughts: (1) Healthy relationships and accountability spanning friendship, community and family relationships (Kinship); (2) Meaning and value in life
• Поведенческое HAVEN Suicide Prevention
  Connect was developed to extend Sources of Strength, an evidence-based suicide prevention program that trains key opinion leaders to disseminate a model of healthy coping to peers, which has been implemented in over 80 secondary schools in New York State. Connect uses a multiple-session group training to build suicide protection at individual and group levels. The first version, Wingman-Connect was developed for young Air Force personnel in training (20% Black or multiracial).

Первичные конечные точки

• Kiddie-Computerized Adaptive Testing for Mental Disorders [Срок оценки: baseline, 1- and 6-month followup]

Вторичные конечные точки (1)

• Kiddie-Computerized Adaptive Testing for Mental Disorders. [Срок оценки: baseline, 1- and 6-month followup]

Критерии участия

Inclusion Criteria: For churches:

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

Exclusion Criteria for Youth:

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

США · 2 центра

• Mt. Sinai Hospital; Ichon School of Medicine — New York
• University of Rochester Medical Center — Rochester

Публикации

• Wyman PA, Pisani AR, Brown CH, Yates B, Morgan-DeVelder L, Schmeelk-Cone K, Gibbons RD, Caine ED, Petrova M, Neal-Walden T, Linkh DJ, Matteson A, Simonson J, Pflanz SE. Effect of the Wingman-Connect Upstream Suicide Prevention Program for Air Force Personnel in Training: A Cluster Randomized Clinical Trial. JAMA Netw Open. 2020 Oct 1;3(10):e2022532. doi: 10.1001/jamanetworkopen.2020.22532. PMID 33084901
• Molock SD, Matlin S, Barksdale C, Puri R, Lyles J. Developing suicide prevention programs for African American youth in African American churches. Suicide Life Threat Behav. 2008 Jun;38(3):323-33. doi: 10.1521/suli.2008.38.3.323. PMID 18611131
• Hankerson SH, Weissman MM. Church-based health programs for mental disorders among African Americans: a review. Psychiatr Serv. 2012 Mar;63(3):243-9. doi: 10.1176/appi.ps.201100216. PMID 22388529
• Gibbons RD, Kupfer DJ, Frank E, Lahey BB, George-Milford BA, Biernesser CL, Porta G, Moore TL, Kim JB, Brent DA. Computerized Adaptive Tests for Rapid and Accurate Assessment of Psychopathology Dimensions in Youth. J Am Acad Child Adolesc Psychiatry. 2020 Nov;59(11):1264-1273. doi: 10.1016/j.jaac.2019.08.009. Epub 2019 Aug 26. PMID 31465832

Идентификаторы

NCT: NCT07401940 · TBT-0-010-21

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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