- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07401940
HAVEN-Connect Youth Suicide Prevention (HAVEN)
A Multi-Generational Suicide Prevention Program in African American Churches
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sherry D Molock, Ph.D., M.Div.
- Phone Number: 13017516217
- Email: smolock@gwu.edu
Study Contact Backup
- Name: Sidney Hankerson, MD
- Phone Number: 212 659-8838
- Email: Sidney.Hankerson@mountsinai.org
Study Locations
-
-
New York
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New York, New York, United States, 10029
- Recruiting
- Mt. Sinai Hospital; Ichon School of Medicine
-
Contact:
- Sidney Hankerson, MD, MBA
- Phone Number: 212-659-8838
- Email: Sidney.Hankerson@mountsinai.org
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Contact:
- Crystal Clarke, MPH
- Phone Number: 212-659-8838
- Email: Crystal.Clarke@mountsinai.org
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Rochester, New York, United States, 14642-0002
- Recruiting
- University of Rochester Medical Center
-
Contact:
- Peter Wyman, Ph.D.
- Phone Number: 585-784-8200
- Email: peter_wyman@urmc.rochester.edu
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Contact:
- Karen Schmeelk-Cone, Ph.D.
- Phone Number: 585-275-6428
- Email: Karen_SchmeelkCone@urmc.rochester.ed
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: HAVEN Intervention Group
Participants receive HAVEN Connect intervention
|
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.
|
|
Placebo Comparator: HAVEN Wait List Control Group
On 6-month wait list where they only receive text messages
|
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).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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" . |
baseline, 1- and 6-month followup
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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 |
baseline, 1- and 6-month followup
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
baseline
|
|
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.
|
baseline (immediately following training
|
|
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.
|
baseline (immediately after training), 3-month follow-up
|
|
Intention to use HAVEN-Connect Skills Questionnaire
Time Frame: baseline (immediately after training), 3-month follow-up
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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.
|
baseline (immediately after training), 3-month follow-up
|
|
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
|
baseline (immediately after training), 3-month follow-up
|
|
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.
|
baseline (immediately after training), 3-month follow-up
|
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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.
|
baseline (immediately after training), 3-month follow-up
|
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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.
|
baseline, 3-month follow up
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: 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
Publications and helpful links
General 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TBT-0-010-21
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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