Our Voices Matter: Intervention for Depression in Youth

Official title

Our Voices Matter: Racial Justice Activism Intervention to Address Structural Racism and Prevent Depression in Black and Latinx Youth

Overview

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.

Detailed description

The investigators will conduct a phase II group-based, multi-component, and multi-level randomized behavioral clinical trial. The investigators will recruit and enroll 300 participants aged 15-20 (N=150 intervention and N=150 control) in Chicago, Illinois. After enrollment, participants will be randomized using a block-stratified randomization technique to ensure balance regarding race, ethnicity, and gender. Once participants are recruited, the investigators will use a computer-generated random number sequence to assign participants to the intervention group (Racial Justice Activism) or control group (Adulting 101: Life Skills Training). Participants assigned to the intervention arm will participate in 5 half-day interactive sessions teaching grassroots organizing and activism specific to SRD. Participants will be assigned to the control arm and will participate in 5 half-day interactive sessions teaching life skills training. Following the activism training, the intervention arm participants will meet virtually in small peer groups to continue advocacy for group-identified SRD issues. Following the life skill attention control programs, control arm participants will meet virtually in small peer groups to continue refresher and discussion of life skills. Participants in the control arm will undergo life skills training with the same number of sessions and duration as the intervention arm.

Participants in both the intervention and control arms will report depressive symptoms on a clinically relevant measure (e.g., Patient Health Questionnaire-9) at baseline and then \<1-, 6-, 12-, 18-, and 24- months post-initial 5-day activism or life skills training. In addition to depressive symptoms, the investigators will measure other aspects of psychological distress, including anxiety and stress as secondary outcomes. Participants in both groups will have biometric samples, like blood draws, and clinical measurements of allostatic load at baseline and then 6-,12-, and 24- months post-initial 5-day activism or life skills training.

The proposed project will use a cluster randomized trial that involves complete groups of individuals randomized to conditions (i.e., intervention, control), with clustering occurring in both arms. All of our statistical analyses will appropriately model the dependency among observations, which is a hallmark of multi-level modeling.

Interventions

• Behavioral Racial Justice Activism Intervention ARM
  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 w
• Behavioral Adulting 101- Control Arm
  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

Primary outcome measures

• Depressive Symptoms [Time frame: at baseline and then 0-1-, 6-, 12-, 18-, and 24- months post initial 5 day-intervention]
• Metabolic Syndrome [Time frame: at baseline and then 6-, 12-, and 24- months post initial 5 day-intervention]
• Blood Pressure [Time frame: at baseline and then 6-, 12-, and 24- months post initial 5 day-intervention]
• Triglycerides [Time frame: at baseline and then 6-, 12-, and 24- months post initial 5 day-intervention]
• High-density lipoprotein [Time frame: at baseline and then 6-, 12-, and 24- months post initial 5 day-intervention]
• Glycosylated hemoglobin [Time frame: at baseline and then 6-, 12-, and 24- months post initial 5 day-intervention]
• Glucose [Time frame: at baseline and then 6-, 12-, and 24- months post initial 5 day-intervention]
• Insulin [Time frame: at baseline and then 6-, 12-, and 24- months post initial 5 day-intervention]
• Waist Circumference [Time frame: at baseline and then 6-, 12-, and 24- months post initial 5 day-intervention]

Secondary outcome measures (9)

• Perceived Stress [Time frame: at baseline and then 0-1 month, 6-, 12-, 18-, and 24- months post initial 5 day-intervention]
• Anxiety [Time frame: at baseline and then 0-1 month, 6-, 12-, 18-, and 24- months post initial 5 day-intervention]
• Inflammation [Time frame: at baseline and then 6-, 12-, and 24- months post initial 5 day-intervention]
• C-Reactive Protein [Time frame: at baseline and then 6-, 12-, and 24- months post initial 5 day-intervention]
• Interleukin-1βeta [Time frame: at baseline and then 6-, 12-, and 24- months post initial 5 day-intervention]
• Interleukin-6 [Time frame: at baseline and then 6-, 12-, and 24- months post initial 5 day-intervention]
• Interleukin-8 [Time frame: at baseline and then 6-, 12-, and 24- months post initial 5 day-intervention]
• Soluble Urokinase Plasminogen Activator Receptor (suPAR) [Time frame: at baseline and then 6-, 12-, and 24- months post initial 5 day-intervention]
• Tumor Necrosis Factor alpha (TNF-α) [Time frame: at baseline and then 6-, 12-, and 24- months post initial 5 day-intervention]

Eligibility criteria

Inclusion criteria

• 15-20 years old
• Identify as Black and/ or Latinx
• Speak English

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Prevention

Study locations

United States · 1 center

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

Publications

• Pinedo A, Durkee MI, Diemer MA, Hope EC. Disentangling longitudinal trajectories of racial discrimination and critical action among Black and Latinx college students: What role do peers play? Cultur Divers Ethnic Minor Psychol. 2021 Jul;27(3):546-557. doi: 10.1037/cdp0000434. Epub 2021 Apr 29. PMID 33914581
• Volpe VV, Schorpp KM, Cacace SC, Benson GP, Banos NC. State- and Provider-Level Racism and Health Care in the U.S. Am J Prev Med. 2021 Sep;61(3):338-347. doi: 10.1016/j.amepre.2021.03.008. Epub 2021 Jun 24. PMID 34419231
• Gaydosh L, Schorpp KM, Chen E, Miller GE, Harris KM. College completion predicts lower depression but higher metabolic syndrome among disadvantaged minorities in young adulthood. Proc Natl Acad Sci U S A. 2018 Jan 2;115(1):109-114. doi: 10.1073/pnas.1714616114. Epub 2017 Dec 18. PMID 29255040
• Volpe VV, Lee DB, Hoggard LS, Rahal D. Racial Discrimination and Acute Physiological Responses Among Black Young Adults: The Role of Racial Identity. J Adolesc Health. 2019 Feb;64(2):179-185. doi: 10.1016/j.jadohealth.2018.09.004. Epub 2018 Nov 6. PMID 30409752
• Hope EC, Brinkman M, Hoggard LS, Stokes MN, Hatton V, Volpe VV, Elliot E. Black adolescents' anticipatory stress responses to multilevel racism: The role of racial identity. Am J Orthopsychiatry. 2021;91(4):487-498. doi: 10.1037/ort0000547. Epub 2021 Apr 22. PMID 34338546
• Cohen A, Ekwueme PO, Sacotte KA, Bajwa L, Gilpin S, Heard-Garris N. "Melanincholy": A Qualitative Exploration of Youth Media Use, Vicarious Racism, and Perceptions of Health. J Adolesc Health. 2021 Aug;69(2):288-293. doi: 10.1016/j.jadohealth.2020.12.128. Epub 2021 Feb 19. PMID 33612361
• Ballard PJ, Syme SL. Engaging youth in communities: a framework for promoting adolescent and community health. J Epidemiol Community Health. 2016 Feb;70(2):202-6. doi: 10.1136/jech-2015-206110. Epub 2015 Oct 6. PMID 26443541
• Heard-Garris N, Ekwueme PO, Gilpin S, Sacotte KA, Perez-Cardona L, Wong M, Cohen A. Adolescents' Experiences, Emotions, and Coping Strategies Associated With Exposure to Media-Based Vicarious Racism. JAMA Netw Open. 2021 Jun 1;4(6):e2113522. doi: 10.1001/jamanetworkopen.2021.13522. PMID 34129023

Identifiers

NCT: NCT07216326 · IRB 2024-6683 · 1R01MD017610-01A1

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗