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HAVEN-Connect Youth Suicide Prevention

A Multi-Generational Suicide Prevention Program in African American Churches

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07401940
Acronym
HAVEN
Enrollment
240
Registered
2026-02-11
Start date
2023-06-01
Completion date
2026-11-30
Last updated
2026-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Suicide Prevention

Keywords

suicide prevention, Black youth, church based prevention

Brief summary

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.

Detailed description

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.

Interventions

BEHAVIORALHAVEN-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 (Purpose); (3) Informal and formal help-seeking (Guidance); and (4) Activities that give strength and balance emotions (Balance). Modules include self-assessment of strength areas, needs and using Four Cores to manage challenging emotions. Group skill-building activities identify strengths of all members, and members learn how a strong network supports all members' well-being. The training uses active learning including high energy activities and peer-to-peer teaching.

BEHAVIORALHAVEN 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).

Sponsors

George Washington University
Lead SponsorOTHER
Mt. Sinai School of Medicine, New York, New York
CollaboratorUNKNOWN
University of Rochester
CollaboratorOTHER
American Foundation for Suicide Prevention
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

This study uses a cluster randomized, wait-list design, with youth clustered within churches, and churches randomly assigned to order of implementation within each site. Randomization will occur at the church level since HAVEN is a multi-level, church-based intervention. In each of 3 cohorts, 4-6 churches will be matched as pairs based on location (Harlem/Rochester) and size for a total of 2-3 pairs per cohort (12-18 churches total). Youth recruitment and baseline assessments of youth will occur simultaneously with church engagement and the Clergy participating in the Faith Based Curriculum. One church from each matched pair will be randomly assigned to begin HAVEN immediately, and the other to a wait-list condition to receive HAVEN approximately 6 months later. The active phase of evaluating HAVEN will span 6-8 months (8 months for wait-listed churches): a 2 month engagement and church leader curriculum phase, followed by HAVEN=Connect training delivered over 1 month.

Eligibility

Sex/Gender
ALL
Age
13 Years to 19 Years
Healthy volunteers
Yes

Inclusion criteria

For churches: 1. 75% of members self-identify as Black or African American, 2. 75% are fluent in English.

Exclusion criteria

for Youth: 1. self-identify as Black/African American, 2. 13-19 years old, are fluent in English

Design outcomes

Primary

MeasureTime frameDescription
Kiddie-Computerized Adaptive Testing for Mental Disordersbaseline, 1- and 6-month followupMeasures 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" .

Secondary

MeasureTime frameDescription
Kiddie-Computerized Adaptive Testing for Mental Disorders.baseline, 1- and 6-month followupDescription: Measures anxiety symptoms. 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 prompt for each question is: "In the past two weeks..." Sample items include: I worried more than I needed to I felt uneasy much of the time It is hard for me to relax My worries overwhelmed me

Countries

United States

Contacts

CONTACTSherry D Molock, Ph.D., M.Div.
smolock@gwu.edu13017516217
CONTACTSidney Hankerson, MD
Sidney.Hankerson@mountsinai.org212 659-8838
PRINCIPAL_INVESTIGATORSherry D Molock, Ph.D., M.Div.

George Washington University, Dept of Psychological & Brain Sciences

PRINCIPAL_INVESTIGATORSidney Hankerson, MD, MBA

Mt. Sinai Icheon School of Medicine - Psychiatry

PRINCIPAL_INVESTIGATORPeter Wyman, Ph.D.

University of Rochester Medical Center - Psychiatry

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 21, 2026