NCT07125144

Brief Summary

Suicide has been the third leading cause of death for Black youth in the U.S since the 1980s and persists as a leading cause of death for Black youth today. For example, in 2018 suicide was reported as the 2nd leading cause of death among Black Americans ages 10 to14 years old. Findings yielded from recent queries indicate that the gap in suicides among Black males and female youth has narrowed in recent years. Despite these disturbing trends, a dearth persists in our understanding of the factors that contribute to and prevent against suicide in Black youth, thus diminishing researchers' ability to effectively detect suicide risk in this particular population. This project aims to redress this gap by proposing the cultural adaptation of an existing suicide prevention intervention, the Signs of Suicide (SOS) prevention program, for Black middle school students. Our team will conduct a pilot randomized controlled trial among a sample of Black middle school students to assess feasibility and examine underlying mechanisms that contribute to suicidality among Black youth. Intervention content will be adapted to assess how topics of racial identity, racial socialization, and racial discrimination uniquely impact Black youth's mental health experiences and risk for suicide. Measures of suicidal ideation, planning, and attempt will be assessed at pre-test, post-test, and 3-months after the intervention. Findings derived from this project will contribute to public health priorities by offering unique insight into the factors that either prevent or promote suicide among Black youth and could be replicated in other schools serving Black students across the nation.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
3mo left

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress85%
Jan 2025Jul 2026

Study Start

First participant enrolled

January 30, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 4, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 15, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2026

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2026

Expected
Last Updated

August 15, 2025

Status Verified

August 1, 2025

Enrollment Period

1.2 years

First QC Date

August 4, 2025

Last Update Submit

August 8, 2025

Conditions

Keywords

Blackyouthsuicidesuicide preventioninterventionSigns of SuicideCultural AdaptationChicagoAfrican AmericanAdolescent

Outcome Measures

Primary Outcomes (1)

  • Suicidal Ideation

    Item that asks students to report if they have seriously considered suicide

    Baseline, 2 weeks after baseline, 3-months after baseline

Secondary Outcomes (3)

  • Suicide Attempt

    Baseline, 2 weeks after baseline, 3-months after baseline

  • Knowledge of Depression and Suicide

    Baseline, 2 weeks after baseline, 3-months after baseline

  • Attitudes Towards Depression and Suicide

    Baseline, 2 weeks after baseline, 3-months after baseline

Study Arms (2)

Standard/Existing Intervention

ACTIVE COMPARATOR

Students attending schools assigned to the Standard/Existing Intervention condition will receive the existing Signs of Suicide intervention.

Behavioral: Signs of Suicide: Standard/Existing

Culturally Adapted Intervention

EXPERIMENTAL

Students attending schools assigned to the Culturally Adapted Intervention condition will receive a new culturally adapted intervention developed for this study.

Behavioral: Black Youth Suicide Prevention in Chicago

Interventions

The Culturally Adapted intervention uses intervention video content that specifically addresses topics that shape Black youth's psychological wellbeing and development. The goal of this intervention is to share suicide prevention information in ways that are culturally responsive and attentive to the specific needs of Black adolescents.

Culturally Adapted Intervention

Students attending schools assigned to the Standard/Existing Intervention condition will receive the Signs of Suicide curriculum.

Standard/Existing Intervention

Eligibility Criteria

Age11 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Enrolled in 6th, 7th, or 8th grade at a participating school

You may not qualify if:

  • Not enrolled in 6th, 7th, or 8th grade at a participating school

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

RECRUITING

MeSH Terms

Conditions

SuicideSuicidal IdeationSuicide, AttemptedSuicide Prevention

Condition Hierarchy (Ancestors)

Self-Injurious BehaviorBehavioral SymptomsBehavior

Study Officials

  • Janelle R. Goodwill, PhD

    University of Chicago

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Janelle R Goodwill, PhD

CONTACT

Miwa Yasui, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Neubauer Family Assistant Professor

Study Record Dates

First Submitted

August 4, 2025

First Posted

August 15, 2025

Study Start

January 30, 2025

Primary Completion

March 31, 2026

Study Completion (Estimated)

July 31, 2026

Last Updated

August 15, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will share

Specific data describing participants grade level and scores on primary outcome measures will be made available, per NIMH Data Archive guidelines.

Shared Documents
ICF
Time Frame
Specific data will be submitted to and hosted on the NIMH Data Archive website.
Access Criteria
Specified data will be shared in compliance with NIMH Data Archive guidelines.

Locations