Our Voices Matter: Intervention for Depression in Youth

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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
• Поведенческое 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

Первичные конечные точки

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

Вторичные конечные точки (9)

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

Критерии участия

Критерии включения

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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

США · 1 центр

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

Публикации

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• 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
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• 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
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• 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

Идентификаторы

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

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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