AzTrials
AzTrials

Suicide PreventionHAVENNCT07401940

HAVEN-Connect Youth Suicide Prevention

A study testing HAVEN-Connect and HAVEN Suicide Prevention in people with Suicide Prevention, run by George Washington University at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 13 to 19 yearsHealthy volunteers can take part
Conditions the study is for
Suicide Prevention
What is being tested?
HAVEN-Connect and HAVEN Suicide Prevention
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
240 participants
Where
2 sitesUnited States
Study dates
1 Jun 2023to 30 Nov 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 to 19 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

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

13017516217

smolock@gwu.edu

United States2 sites, 2 recruiting
  • Mt. Sinai Hospital; Ichon School of Medicine

    New York, New York, 10029

    Sidney Hankerson, MD, MBA, 212-659-8838, Sidney.Hankerson@mountsinai.org

    Crystal Clarke, MPH, 212-659-8838, Crystal.Clarke@mountsinai.org

    Recruiting
  • University of Rochester Medical Center

    Rochester, New York, 14642-0002

    Peter Wyman, Ph.D., 585-784-8200, peter_wyman@urmc.rochester.edu

    Karen Schmeelk-Cone, Ph.D., 585-275-6428, Karen_SchmeelkCone@urmc.rochester.ed

    Recruiting

Other trials in United States

About this study

Official title: A Multi-Generational Suicide Prevention Program in African American Churches

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.

Read the 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.

Being tested
HAVEN-Connect, HAVEN Suicide Prevention
Keywords
suicide prevention, Black youth, church based prevention
Medical subject headings
Suicide Prevention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HAVEN-ConnectBehavioural

    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 Suicide PreventionBehavioural

    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).

Study groups in NCT07401940
Study groupRoleWhat they receive
HAVEN Intervention GroupExperimentalParticipants receive HAVEN Connect intervention
Receives: Behavioral: HAVEN-Connect
HAVEN Wait List Control GroupPlacebo comparatorOn 6-month wait list where they only receive text messages
Receives: Behavioral: HAVEN Suicide Prevention

What is being measured

The primary outcome is the main question the study is designed to answer.

  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"

    .

    Measured: baseline, 1- and 6-month followup

Secondary outcomes (1)
  1. Kiddie-Computerized Adaptive Testing for Mental Disorders.

    Description: 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

    Measured: baseline, 1- and 6-month followup

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Feb 2026
  2. Study start1 Jun 2023
  3. Primary completion30 Nov 2026 (estimated)
  4. Study completion30 Nov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
None (open label)
Enrolment
240 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07401940
Sponsor's protocol ID
TBT-0-010-21
Acronym
HAVEN
Status last verified
Jul 2026
First submitted
3 Dec 2025
Last updated
20 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The final data set will include 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. User registration is required in order to access or download files. Users must agree to the conditions of use governing access to the public release data, including restrictions against attempting to identify study participants, destruction of the data after analyses are completed, reporting responsibilities, restrictions on redistribution of the data to third parties, and proper acknowledgement of the data resource. Registered users will receive user support, information related to errors in the data, future releases, workshops, and publication lists. Data cannot be used for commercial purposes or distributed to third parties

Publications

  • 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 31465832

Questions about this trial

What is this clinical trial studying?

A study testing HAVEN-Connect and HAVEN Suicide Prevention in people with Suicide Prevention, run by George Washington University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sherry D Molock, Ph.D., M.Div. (13017516217, smolock@gwu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Kiddie-Computerized Adaptive Testing for Mental Disorders (time frame: baseline, 1- and 6-month followup). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07401940, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in