Engaging Black Youth in Depression and Suicide Prevention Treatment Within Urban Schools
NCT ID: NCT03940508
Last Updated: 2025-09-15
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
29 participants
INTERVENTIONAL
2020-01-31
2023-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Preventing Depression in the Children of Depressed African American Mothers
NCT00904917
African American Knowledge Optimized for Mindfully Healthy Adolescents
NCT00578318
Reducing Depression-related Stigma and Increasing-treatment Seeking Among Black Adolescents
NCT04890990
Interpersonal Psychotherapy for Depressed Adolescents Engaging in Non-suicidal Self-injury
NCT00401102
Reducing Stigma and Increasing Treatment Seeking Intentions Among Adolescents
NCT06222528
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
MCI + IPT-A
Participants will receive the Making Connections Intervention (MCI) in addition to IPT-A for depression.
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.
IPT-A
IPT-A is a time-limited, manualized treatment for depression focused on maladaptive communication patterns and interpersonal interactions.
IPT-A Only
Participants will receive IPT-A for depression.
IPT-A
IPT-A is a time-limited, manualized treatment for depression focused on maladaptive communication patterns and interpersonal interactions.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
IPT-A
IPT-A is a time-limited, manualized treatment for depression focused on maladaptive communication patterns and interpersonal interactions.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
Exclusion Criteria
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
12 Years
20 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute of Mental Health (NIMH)
NIH
Columbia University
OTHER
New York University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Michael A Lindsey, PhD
Role: PRINCIPAL_INVESTIGATOR
NYU Silver School of Social Work
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Columbia University
New York, New York, United States
McSilver Institute for Poverty Policy and Research
New York, New York, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Gunlicks-Stoessel M, Mufson L, Jekal A, Turner JB. The impact of perceived interpersonal functioning on treatment for adolescent depression: IPT-A versus treatment as usual in school-based health clinics. J Consult Clin Psychol. 2010 Apr;78(2):260-7. doi: 10.1037/a0018935.
Mufson L, Moreau D, Weissman MM, Wickramaratne P, Martin J, Samoilov A. Modification of interpersonal psychotherapy with depressed adolescents (IPT-A): phase I and II studies. J Am Acad Child Adolesc Psychiatry. 1994 Jun;33(5):695-705. doi: 10.1097/00004583-199406000-00011.
Mufson LH, Dorta KP, Olfson M, Weissman MM, Hoagwood K. Effectiveness research: transporting interpersonal psychotherapy for depressed adolescents (IPT-A) from the lab to school-based health clinics. Clin Child Fam Psychol Rev. 2004 Dec;7(4):251-61. doi: 10.1007/s10567-004-6089-6.
Lindsey MA, Chambers K, Pohle C, Beall P, Lucksted A. Understanding the Behavioral Determinants of Mental Health Service Use by Urban, Under-Resourced Black Youth: Adolescent and Caregiver Perspectives. J Child Fam Stud. 2013 Jan 1;22(1):107-121. doi: 10.1007/s10826-012-9668-z. Epub 2012 Oct 16.
Lindsey MA, Joe S, Nebbitt V. Family Matters: The Role of Mental Health Stigma and Social Support on Depressive Symptoms and Subsequent Help Seeking Among African American Boys. J Black Psychol. 2010 Nov 1;36(4):458-482. doi: 10.1177/0095798409355796.
Breland-Noble AM, Bell CC, Burriss A; AAKOMA Project Adult Advisory Board. "Mama just won't accept this": adult perspectives on engaging depressed African American teens in clinical research and treatment. J Clin Psychol Med Settings. 2011 Sep;18(3):225-34. doi: 10.1007/s10880-011-9235-6.
Lindsey MA, Korr WS, Broitman M, Bone L, Green A, Leaf PJ. Help-seeking behaviors and depression among African American adolescent boys. Soc Work. 2006 Jan;51(1):49-58. doi: 10.1093/sw/51.1.49.
Lindsey MA, Brown DR, Cunningham M. Boys do(n't) cry: Addressing the unmet mental health needs of African American boys. Am J Orthopsychiatry. 2017;87(4):377-383. doi: 10.1037/ort0000198.
Ellis ML, Lindsey MA, Barker ED, Boxmeyer CL, Lochman JE. Predictors of engagement in a school-based family preventive intervention for youth experiencing behavioral difficulties. Prev Sci. 2013 Oct;14(5):457-67. doi: 10.1007/s11121-012-0319-9.
Lindsey MA, Mufson L, Velez-Grau C, Grogan T, Wilson DM, Reliford AO, Gunlicks-Stoessel M, Jaccard J. Engaging Black youth in depression and suicide prevention treatment within urban schools: study protocol for a randomized controlled pilot. Trials. 2024 Feb 9;25(1):112. doi: 10.1186/s13063-024-07947-8.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
Access external resources that provide additional context or updates about the study.
Lu W, Lindsey M, Irsheid S, Nebbitt V. Psychometric properties of the center for epidemiological studies-depression Scale (CES-D) among Black adolescents. Journal of the Society for Social Work and Research. 2017.
Other Identifiers
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.