Our Voices Matter: Intervention for Depression in Youth

NCT07216326 | Recruiting

• 2 other identifiers: IRB 2024-66831R01MD017610-01A1
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Over 15 million people participated in racial justice protests nationwide during 2020-2021 spotlighting activism as a collective tool against structural racism and discrimination (SRD). SRD manifests as policies and practices (e.g., redlining, voter suppression, mass incarceration) that produce hostile environments that contribute to psychological distress, elevated allostatic load, and an elevated risk for chronic diseases and premature death, concentrated within Black and Latinx populations. While the connection between SRD and health is well documented, few studies provide evidence on strategies to reduce SRD and mitigate consequences on psychological and physiological outcomes. Thus, there is a critical need to rigorously test interventions that improve the mental and physical health of Black and Latinx populations, beginning in adolescence. The study's specific aims are to 1) Determine whether a racial justice activism behavioral intervention prevents and reduces depressive symptoms in Black and Latinx adolescents and young adults and 2) Determine whether a racial justice activism behavioral intervention lowers allostatic load scores in Black and Latinx adolescents and young adults. To accomplish these aims, the team will conduct a stage II group-based, multi-component, and multilevel randomized behavioral clinical trial. The investigators will collect psychological and physiological measures at baseline, then at defined intervals for 2 years post the racial justice activism intervention.

Conditions

Depressive Symptoms; Allostatic Load; Metabolic Syndrome

Keywords

mental health; youth intervention; allostatic load; stress; depressive symptoms; depression; metabolic syndrome; prevention; inflammation

Outcome Measures

Primary Outcomes (9)

• Depressive Symptoms

  To evaluate depressive symptoms and overall depression, the investigators will use the following measurement tools: the Patient Questionnaire-9 \[PHQ-9\]. The investigators have chosen these metrics because these tools have been validated within our study population and the PHQ-9 is used in clinical practice. The Patient Health Questionnaire-9 (PHQ-9) is used in clinical practice to diagnose and manage depression and has a minimal clinically important difference (MCID) of 5 points on the PHQ-9 total score. The minimum is a score of 0 and the maximum is a score of 27, with higher scores indicating worse depressive symptoms. The scoring is as follows: Scores 0-4: None/minimal depression, 5-9: mild depression, 10-14: moderate depression, 15-19: moderately severe depression, 20-27: severe depression.

  at baseline and then 0-1-, 6-, 12-, 18-, and 24- months post initial 5 day-intervention

• Metabolic Syndrome

  Biomarkers will be collected from these systems: cardiovascular (e.g., systolic and diastolic blood pressure (measured in mmHg), serum triglycerides (mg/dL) and HDL cholesterol (mg/dL), metabolic (e.g., glycosylated hemoglobin \[HbA1c-(mg/dL)\] , fasting glucose (mg/dL), waist circumference (cm), and insulin (U/ML). Will measure seated blood pressure, height (cm), weight (Kg), and waist circumference using the same protocols used in the HCHS/SOL Youth for rigor and reproducibility. To arrive at one reported value of metabolic syndrome, we will 1. a count of the number of signs that meet International Diabetes Federation (IDF) criteria, and 2. also create continuous metabolic risk score. To calculate this score, each biomarker will have values standardized into a z-score, then sum the z-scores, (Before transformation waist circumference will be normed for age, sex, and race using nationally representative data from NHANES.)

  at baseline and then 6-, 12-, and 24- months post initial 5 day-intervention

• Blood Pressure

  The investigators will measure systolic and diastolic blood pressure (measured in mmHg) using a size-appropriate blood pressure cuff.

  at baseline and then 6-, 12-, and 24- months post initial 5 day-intervention

• Triglycerides

  The investigators will measure serum triglycerides (mg/dL) as a component of lipid markers.

  at baseline and then 6-, 12-, and 24- months post initial 5 day-intervention

• High-density lipoprotein

  The investigators will measure HDL cholesterol (mg/dL) as a component of lipid markers.

  at baseline and then 6-, 12-, and 24- months post initial 5 day-intervention

• Glycosylated hemoglobin

  The investigators will measure HbA1c (mg/dL) as a marker of metabolic health.

  at baseline and then 6-, 12-, and 24- months post initial 5 day-intervention

• Glucose

  The investigators will measure fasting glucose (mg/dL) as a marker of metabolic health.

  at baseline and then 6-, 12-, and 24- months post initial 5 day-intervention

• Insulin

  The investigators will measure insulin (U/ML) as a marker of metabolic health.

  at baseline and then 6-, 12-, and 24- months post initial 5 day-intervention

• Waist Circumference

  The investigators will measure waist circumference (cm) as a marker of metabolic health.

  at baseline and then 6-, 12-, and 24- months post initial 5 day-intervention

Secondary Outcomes (9)

• Perceived Stress

  at baseline and then 0-1 month, 6-, 12-, 18-, and 24- months post initial 5 day-intervention

• Anxiety

  at baseline and then 0-1 month, 6-, 12-, 18-, and 24- months post initial 5 day-intervention

• Inflammation

  at baseline and then 6-, 12-, and 24- months post initial 5 day-intervention

• C-Reactive Protein

  at baseline and then 6-, 12-, and 24- months post initial 5 day-intervention

• Interleukin-1βeta

  at baseline and then 6-, 12-, and 24- months post initial 5 day-intervention

Study Arms (2)

RJA Intervention Arm

EXPERIMENTAL

The "Our Voices Matter" RJA intervention is a block-stratified randomized, group behavioral intervention designed for Black and Latinx adolescents and young adults (AYAs). The curriculum will specifically focus on the principles of education, organizing, policy development, and legal advocacy. Participants will have didactic sessions, which include policy debates, keynote lectures, seminars, and trainings led by local leaders, community activists, and other experts on civil rights. Participants will learn how to use data to understand how structural barriers influence life. Participants will understand and analyze policy and develop action plans to influence SRD. Additionally, the program will create a network of supportive peers. After the RJA training, small groups will meet monthly via videoconference for 1-year post-intervention. This intervention aims to equip Black and Latinx AYAs with civic and grassroots organizing knowledge and peer support.

Behavioral: Racial Justice Activism Intervention ARM

Adulting 101

PLACEBO COMPARATOR

Adulting 101: Life Skills attention control is a 5- day in-person program that will meet for the same number of sessions and duration as the intervention. This attention control is based on the "Project Life" program developed initially for individuals supporting youth transitioning out of foster care to teach life skills for independent living. This curriculum is delivered through didactic and interactive modules that provide knowledge and informational resources, along with hands-on activities and life skills demonstrations. Sessions include: 1) Community Building, 2) Career Preparation, 3) Education, 4) Money Management, 5) Health and Nutrition, 6) Home Management, and 7) Story Sharing.

Behavioral: Adulting 101- Control Arm

Interventions

Racial Justice Activism Intervention ARM BEHAVIORAL

The "Our Voices Matter" RJA intervention is a block-stratified randomized, group behavioral intervention designed for Black and Latinx adolescents and young adults (AYAs). The curriculum will specifically focus on the principles of activism, organizing, policy development, and legal advocacy. Participants will have didactic sessions, which include policy debates, keynote lectures, seminars, and trainings led by local leaders, community activists, and other experts on civil rights. Participants will learn how to use data to understand how structural racism and discrimination (SRD) influence life. Participants will understand and analyze policy and develop action plans to influence SRD. Additionally, the program will create a network of supportive peers. After the RJA training, small groups will meet monthly via videoconference for 1-year post-intervention. This intervention aims to equip Black and Latinx AYAs with civic and grassroots organizing knowledge and peer support.

Also known as: RJA Intervention ARM

RJA Intervention Arm

Adulting 101- Control Arm BEHAVIORAL

Adulting 101: Life Skills attention control is a 5- day in-person program (Figure 4) that will meet for the same number of sessions and duration as the intervention. This attention control is based on the "Project Life" program,84 developed initially for individuals supporting youth transitioning out of foster care to teach life skills for independent living. This curriculum is delivered through didactic and interactive modules that provide knowledge and informational resources, along with hands-on activities and life skills demonstrations. Sessions include: 1) Community Building, 2) Career Preparation, 3) Education, 4) Money Management, 5) Health and Nutrition, 6) Home Management, and 7) Story Sharing, which culminates with a Day of Action. Participants will learn skills for adulthood and gain experience developing career and education goals. Like the intervention condition, participants will actualize their skills on the final day, called the "Day of Action."

Also known as: Adulting/RJA Control

Adulting 101

Eligibility Criteria

• Age: 15 Years - 20 Years
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• years old
• Identify as Black and/ or Latinx
• Speak English

You may not qualify if:

• Younger than 15 years old, or older than 20 years old
• Unable to attend the in-person sessions
• Non-fluent English speaker
• Do not identify as Black or Latinx

Sponsors & Collaborators

• Ann & Robert H Lurie Children's Hospital of Chicago: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator
• Policy Research Associates: collaborator

Study Sites (1)

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

RECRUITING

Related Publications (30)

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  BACKGROUND

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• Hope EC, Cryer-Coupet QR, Stokes MN. Race-related stress, racial identity, and activism among young Black men: A person-centered approach. Dev Psychol. 2020 Aug;56(8):1484-1495. doi: 10.1037/dev0000836.

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MeSH Terms

Conditions

Depression; Metabolic Syndrome; Psychological Well-Being; Inflammation

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Personal Satisfaction; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Elan C Hope, PhD

  Policy Research Associates

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nia Heard-Garris, MD, MBA, MSc

CONTACT

3122272664; nheardgarris@luriechildrens.org

Akram Ibrahim, MS

CONTACT

312-227-6944; akibrahim@luriechildrens.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics

Study Record Dates

• First Submitted: December 9, 2024
• First Posted: October 14, 2025
• Study Start: June 6, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 29, 2028
• Last Updated: October 14, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Research data will be made publicly available through posting on open websites, presentations, and peer-reviewed publications (in some cases after an embargo period not to exceed one year). Inventions appropriate for commercialization will be protected via intellectual property (IP) filings, commercialized, and provided to society as products or services by or through the Innovation and New Ventures Office, NU's technology transfer office. Innovation and New Ventures Office manages NU's invention disclosure, assessment, patenting, and marketing processes. NU is committed to the free exchange of data and resources and for the rapid commercialization of biomedical inventions for the benefit of the public, consistent with the terms of the Bayh-Dole Act. NU's commercialization practices to date have maximized the public benefit of inventions arising from federal funding by providing useful, commercially relevant, and available products and services.
• Access Criteria: Data and resource sharing is an essential to the study activities. The team will share the data and resources generated by this project by making our findings, intervention materials and protocols (e.g., training materials, manuals, etc.), available to the following communities: 1. Scientists interested in developing, implementing, and testing activism as an approach to reduce the health risks associated with structural racism, particularly among adolescent and young adult populations. Data and resource sharing with this community will encourage dialogue about the nuances of activism as a youth health intervention, implementation, and evaluation research in youth-focused community settings. 2. Practitioners, clinicians, youth educators, administrators, and other decision-makers, so our findings may be used to inform youth civic education and advocacy programming; 3. The community at large, so adolescents, young adults, and their caregivers and educators can use our findings

Locations

US (1)