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NCT Number: NCT07401940

HAVEN-Connect Youth Suicide Prevention

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.

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Key information

Age range

13 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mt. Sinai Hospital; Ichon School of Medicine, New York, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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 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).

Primary outcomes

  1. Kiddie-Computerized Adaptive Testing for Mental Disorders

    Time frame: 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"

    .

Secondary outcomes

  1. Kiddie-Computerized Adaptive Testing for Mental Disorders.

    Time frame: baseline, 1- and 6-month followup

    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

Other outcomes

  1. Demographic Questionnaire

    Time frame: baseline

    Measures demographic characteristics of sample (e.g., age, race, gender, gender identity, GPA, etc.). Will be used to describe characteristics of sample and to ascertain if demographic groups respond differently to the prevention program (e.g.., age or gender differences in response to the program.

  2. General Training Satisfaction Questionnaire

    Time frame: baseline (immediately following training

    Adult participants receive a brief set of questions to assess general satisfaction. with the program, n of items = 3. measured on a Likert scale: (0 = not at all - 3 = very much) score range = 0-9 with high scores interpreted as being high training satisfaction.

  3. Retention of Skills Questionnaire

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

    Adult participants will receive a brief set of questions to assess perceptions of the training, retention and adoption of training information, and use of concepts in life. n of items = 7. measured on a dichotomous scale: (0 = false, 1 = True) score range = 0-7 with high scores interpreted as high retention of skills learned from the prevention program.

  4. Intention to use HAVEN-Connect Skills Questionnaire

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

    Assess perceptions of intention to use the skills learned in the HAVEN prevention program. n of items = 7, measured on a Likert scale: (0 = strongly disagree to 100 = strongly agree). score range = 0-100 (calculate the mean score), with high scores interpreted as having high intentions to use newly acquired skills gained from the training sessions.

  5. Intention to Use Skills with Youth Questionnaire

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

    Assess intentions to use newly acquired skills with youth in the future. n of items = 5, measured on a Likert scale: (0 = strongly disagree to 100 = strongly agree). score range = 0-100 (calculate the mean score), with high scores interpreted as having high intentions to use newly acquired skills gained from the training sessions with youth

  6. Adoption of Skills Questionnaire

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

    Assess perceptions of the training, retention and adoption of training information, and use of concepts in life. n of items = 5, measured on a Likert scale: (0 = strongly disagree to 100 = strongly agree). score range = 0-100 (calculate the mean score), with high scores interpreted as believing the person will adopt the skills acquired through the program to daily life.

  7. Experience Engaging Youth with Skills Questionnaire

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

    Assess use of core concepts in interactions with youth. n of items = 5, measured on a Likert scale: (0 = strongly disagree to 100 = strongly agree). score range = 0-100 (calculate the mean score), with high scores interpreted as having high intentions to actively engage the youth with newly acquired skills gained from the training sessions.

  8. Adult Peer Network Questionnaire

    Time frame: baseline, 3-month follow up

    Adults nominate close friends at church. Asked to name up to 7 adults who serve as a support network for the adults. Range is from 0-7. Higher numbers indicate more peers in peer network.

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

[email protected]

13017516217

Sidney Hankerson, MD

CONTACT

[email protected]

212 659-8838

Sponsors and collaborators

Lead sponsor

George Washington University

Other

Collaborators

  • American Foundation for Suicide Prevention
  • Mt. Sinai School of Medicine, New York, New York
  • University of Rochester

Registry information

Official study title

A Multi-Generational Suicide Prevention Program in African American Churches

Acronym: HAVEN

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Feb 11, 2026
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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