Engaging Black Youth in Depression and Suicide Prevention Treatment Within Urban Schools

September 11, 2025 updated by: New York University

Engaging Black Youth in Depression and Suicide Prevention Treatment Within Urban Schools: A Preliminary Study

Completing evidence-based treatments for depression has been shown to be particularly problematic for Black adolescents. If Black adolescents' depression treatment needs are to be met, the engagement challenges and the factors that lessen the success of treatment in the "real world" must be addressed. The investigators will examine the effectiveness of the Making Connections Intervention (MCI) and investigate key mediators of both engagement and response to treatment for depression. The MCI is a 1-2 session, evidence-based intervention designed to improve engagement, perceived relevance, and treatment satisfaction among depressed, Black adolescents. The study also uses tailored outreach strategies for adolescents and parents by including innovative digital content such as a web page/app along with other digital products.

This study will address an important public health issue: How best to connect Black adolescents with depression to treatment in clinically meaningful ways, and how best to deliver evidence-based treatment to them through school-based services.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Completing evidence-based treatments for depression has been shown to be particularly problematic for Black adolescents. Their rates of participation in treatments for depression are lower due to negative perceptions of services and providers, and their reluctance to acknowledge the presence of symptoms.

If Black adolescents' depression treatment needs are to be met, the engagement challenges and the factors that lessen the success of treatment in the "real world" must be addressed. This research examines the effectiveness of the Making Connections Intervention (MCI) and investigates key mediators of both engagement and response to treatment for depression. The MCI is a 1-2 session, evidence-based intervention designed to improve engagement, perceived relevance, and treatment satisfaction among depressed, Black adolescents. The study also uses tailored outreach strategies for adolescents and parents by including innovative digital content such as a web page/app along with other digital products.

The investigators previously performed a small pilot study that used the MCI as an add-on to the IPT-A, an evidence-based intervention for depression delivered in schools typically over 12 sessions. The results suggested that MCI has a positive impact on many aspects of change associated with treatment engagement and clinical outcomes.

This study will be a randomized controlled trial. It will examine the effectiveness of the MCI in a multi-school trial involving adolescents in grades 6-12 who attend New York City (NYC) Department of Education (DOE) Public Schools. The investigators will randomly assign 60 Black students with depression symptoms to two conditions: MCI+IPT-A vs. IPT-A-alone. The investigators will also do qualitative research, like interviews, before the digital content is created. This will enhance the relevance of the MCI. The main outcomes are adolescent-and caregiver-level engagement and adolescent depression. Suicidal ideation is a secondary outcome. This study will also test related factors, like adolescent helping-seeking behavior and parental knowledge of mental health services, that can account for treatment outcomes and that will allow the MCI to be strengthened in future roll-outs of the intervention in school settings.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
29

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Tracy M Grogan, MS
  • Phone Number: (212) 992-6902
  • Email: tmg374@nyu.edu

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10003
        • Columbia University
      • New York, New York, United States, 10003
        • McSilver Institute for Poverty Policy and Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

12 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Must identify as Black and/or African American
  2. Must be enrolled in grades 6-12 (except 12th graders in their last semester)
  3. Must be able to speak English
  4. Must have received caregiver consent and have assented to participate
  5. Must meet depression and global functioning levels indicated by a CES-D score ≥16, a Hamilton Rating Scale of Depression (HRSD) Score ≥ 10, and a Global Assessment Scale for Children (C-GAS) score ≤ 65 at baseline
  6. Students who are currently on a stable dose of anti-depressant medication, but still meet inclusion criteria, can be enrolled in the study.

Exclusion Criteria:

  1. Actively suicidal with intent or plan
  2. Intellectually disabled
  3. Have a life threatening medical illness
  4. Have a current primary substance abuse diagnosis in the moderate to severe range, schizophrenia, bipolar disorder, any evidence of psychosis, a primary diagnosis of anorexia
  5. Currently in active treatment for depression (excluding medication) at baseline assessment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: MCI + IPT-A
Participants will receive the Making Connections Intervention (MCI) in addition to IPT-A for depression.
Behavioral: Making Connections Intervention
The MCI is a one to two session intervention that addresses barriers to mental health treatment and helps adolescents build skills to get the most out of their treatment experience. It is designed to be delivered by a trained clinician in conjunction with an evidence-based treatment.
Behavioral: IPT-A
IPT-A is a time-limited, manualized treatment for depression focused on maladaptive communication patterns and interpersonal interactions.
Other Names:
  • Interpersonal Psychotherapy for Depressed Adolescents
Active Comparator: IPT-A Only
Participants will receive IPT-A for depression.
Behavioral: IPT-A
IPT-A is a time-limited, manualized treatment for depression focused on maladaptive communication patterns and interpersonal interactions.
Other Names:
  • Interpersonal Psychotherapy for Depressed Adolescents

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Center for Epidemiological Studies-Depression Scale
Time Frame: Baseline
A 20-item self-report scale designed to measure depressive symptomatology in the general population. Scores range from 0 to 60, with higher scores indicating greater depression symptoms. 16 is a common clinical cutoff.
Baseline
Hamilton Rating Scale for Depression
Time Frame: Baseline
Determines a patient's level of depression before, during, and after treatment. Scores range from 0 to 52, with higher scores indicating greater severity of depression. Scores of 0-7 indicate no depression.
Baseline
Demographic Form
Time Frame: Baseline
To measure participants' demographic characteristics
Baseline
Columbia-Suicide Severity Rating Scale
Time Frame: Baseline
To assess the severity and lethality of suicidal behaviors and ideations, and can be used to monitor treatment outcomes and establish suicide risk in a variety of research and clinical settings. "Yes" and "No" categories are used to determine suicide risk, with binary coding where No=0 and Yes=1 for items 1-5. The higher number indicating more intense ideation. Total scores of items 1-5 were analyzed, with the lowest score =0 and the highest score=5.
Baseline
Barriers for Adolescents Seeking Health
Time Frame: Baseline
Self-report questionnaire that targets barriers to seeking professional psychological help. Scores range from 37 to 111, with higher scores indicating greater barriers to help seeking behaviors.
Baseline
Child Help-Seeking Scale
Time Frame: Baseline
Self-report 28-item questionnaire designed to measure children's and adolescents' willingness to seek help for psychosocial problems from adults in the school setting. Scores for part one range from 16 to 64 and scores for part two rang from 7 to 28, with higher scores indicating less help- seeking.
Baseline
Attitudes Toward Psychological Help Scale
Time Frame: Baseline
This scale assesses psychological factors, including stigma, perceived relevance of treatment, etc., that impact one's perceptions of and attitudes about using formal mental health treatment services. Scores range from 0-15, with higher scores indicating greater stigma.
Baseline
Stages of Change
Time Frame: Baseline
32-item instrument for assessing the readiness for changes in relation to general problems, or problems associated with participation in psychotherapy. The highest score among each sub-scale indicates which stage of change a person is in. Thus, sub-scale scores are reported. Sub-scale scores do not indicate a better or worse outcome; instead, higher scores indicate a readiness to take action to address mental health concerns on each sub-scale. Pre-contemplation scores range from 5-20, Contemplation scores range from 4-16, Action scores range from 5-20, and Maintenance scores range from 4-16.
Baseline
Barriers to Treatment Participation Scale
Time Frame: Baseline
To test whether perceived barriers to treatment influence dropping out and other measures of participation in treatment. To assess a broad range of barriers evident over the course of treatment, including four thematic areas: stressors and obstacles that compete with treatment, treatment demands and issues, perceived relevance of treatment, and relationship with the therapist. Higher scores indicating greater barriers to treatment. Sub-scale scores range from 20 to 100 (Stressors), 10-50 (Demands), and 8-40 (Perceived Relevance of Treatment).
Baseline
Understanding Mood Disorders Questionnaire
Time Frame: Baseline
Designed to measure family members' attributions about and knowledge of symptoms, course, and treatment of mood disorders. Scores range from 9 to 40, with higher scores indicating less understanding of how depression presents and functions.
Baseline
Therapy Survey
Time Frame: Baseline
To measure change in expectations about treatment at a children's psychiatric clinic about a week before their first therapy and counseling sessions. Scores range from 7 to 35, with higher scores indicating misconceptions about the role of therapy.
Baseline
Suicidal Ideation Questionnaire-Junior
Time Frame: Baseline
A 15-item self-report measure developed specifically for identifying and assessing current suicidal ideation among young adolescents that requires approximately five to eight minutes to complete. Scores range from 0 to 90, with a typical clinical cutoff score of 31 indicating further evaluation due to increased risk of suicidal ideation.
Baseline
Global Assessment Scale for Children
Time Frame: Baseline
To reflect the lowest level of functioning for a child or adolescent during a specified time period, or on a hypothetical continuum of health-illness. Higher scores indicate higher functioning, ranging from 1-100.
Baseline
Interpersonal Needs
Time Frame: Baseline
A 15-item questionnaire to measure changes in students' social connectedness and social competence. Total scores ranging from 15-99 are reported with higher scores indicated less social connectedness.
Baseline
Penn Helping Alliance Revised
Time Frame: Week 4
This questionnaire collects data from both the therapist and patient to measure the strength of the bond between therapist and patient, called the therapeutic alliance. Scores range from 6 to 36, with a higher score indicating greater therapeutic alliance.
Week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
New York University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Mental Health (NIMH)
Columbia University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Michael A Lindsey, PhD, NYU Silver School of Social Work

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 31, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 29, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 3, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 7, 2019

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 15, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 11, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1R34MH119290-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Submit data in compliance with NIMH Data Archive data submission agreement.

IPD Sharing Time Frame

By the end of data collection, December 2023.

IPD Sharing Access Criteria

In accordance with the NIMH Data Archive requirements.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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