HAVEN-Connect Youth Suicide Prevention

NCT07401940 | Recruiting

• 1 other identifier: TBT-0-010-21
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 2

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.

Conditions

Suicide Prevention

Keywords

suicide prevention; Black youth; church based prevention

Outcome Measures

Primary Outcomes (1)

• Kiddie-Computerized Adaptive Testing for Mental Disorders

  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" .

  baseline, 1- and 6-month followup

Secondary Outcomes (1)

• Kiddie-Computerized Adaptive Testing for Mental Disorders.

  baseline, 1- and 6-month followup

Other Outcomes (8)

• Demographic Questionnaire

  baseline

• General Training Satisfaction Questionnaire

  baseline (immediately following training

• Retention of Skills Questionnaire

  baseline (immediately after training), 3-month follow-up

Study Arms (2)

HAVEN Intervention Group

EXPERIMENTAL

Participants receive HAVEN Connect intervention

Behavioral: HAVEN-Connect

HAVEN Wait List Control Group

PLACEBO COMPARATOR

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

Behavioral: HAVEN Suicide Prevention

Interventions

HAVEN-Connect BEHAVIORAL

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.

HAVEN Intervention Group

HAVEN Suicide Prevention BEHAVIORAL

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).

HAVEN Wait List Control Group

Eligibility Criteria

• Age: 13 Years - 19 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• George Washington University: lead
• Mt. Sinai School of Medicine, New York, New York: collaborator
• University of Rochester: collaborator
• American Foundation for Suicide Prevention: collaborator

Study Sites (2)

Mt. Sinai Hospital; Ichon School of Medicine

New York, New York, 10029, United States

RECRUITING

University of Rochester Medical Center

Rochester, New York, 14642-0002, United States

RECRUITING

Related Publications (4)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Suicide Prevention

Condition Hierarchy (Ancestors)

Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Study Officials

• Sherry D Molock, Ph.D., M.Div.

  George Washington University, Dept of Psychological & Brain Sciences

  PRINCIPAL INVESTIGATOR

• Sidney Hankerson, MD, MBA

  Mt. Sinai Icheon School of Medicine - Psychiatry

  PRINCIPAL INVESTIGATOR

• Peter Wyman, Ph.D.

  University of Rochester Medical Center - Psychiatry

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sherry D Molock, Ph.D., M.Div.

CONTACT

13017516217; smolock@gwu.edu

Sidney Hankerson, MD

CONTACT

212 659-8838; Sidney.Hankerson@mountsinai.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 3, 2025
• First Posted: February 11, 2026
• Study Start: June 1, 2023
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: July 20, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Start Date: June 1, 2029 How long: 2years
• Access Criteria: Registered users will have access to: demographic information, outcome data (suicide ideation and attempts, depression, anxiety, PTSD) and possible mediators, including mental health service utilization, peer networks, help-seeking acceptability, peer norms, trusted adult network, etc. Data products will be made available without costs to researchers. Can access data by contacting the PI, who will provide a link to the data.

Locations

US (2)