Rise & Thrive: Community-Engagement Intervention for Stress and Depression in Youth.

Официальное название

Rise & Thrive: Community-Engagement Intervention to Address Chronic Stress and Prevent Depression in Adolescents and Young Adults

Обзор

American youth and young adults face persistent and chronic stressors, which have contributed to a mental health crisis in the United States. Four in 10 American high school students experience chronic feelings of sadness and hopelessness, 2 in 10 report suicidal ideation, and 1 in 10 attempt suicide. For adolescents and young adults, chronic stress translates to weathering, or wear and tear on the mind and body. Chronic stress in youth contributes to psychological distress, elevated allostatic load, and an elevated risk for chronic diseases and premature death. While the connection between chronic stress and health is well documented, few studies provide evidence on innovative, non-medication strategies to reduce stress and mitigate the consequences of chronic stress on psychological and physiological outcomes. Thus, there is a critical need to rigorously test interventions that prevent the negative influence of chronic stress on mental and physical health, beginning in adolescence. The specific aims of the study are to 1) Determine whether a community-engagement, peer-based behavioral intervention reduces depressive symptoms in adolescents and young adults, 2) Determine whether a community-engagement behavioral intervention lowers allostatic load scores in adolescents and young adults, and 3) Identify factors that help sustain or inhibit community-engagement and intervention effects for adolescents and young adults. To accomplish these aims, the team will conduct a phase II community-engaged, peer group-based, multi-component randomized behavioral clinical trial. We will collect psychological and physiological measures at baseline, then at 6-month intervals for 2 years post-community-engaged, skills training.

Подробное описание

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 (Rise Community Engagement) or control group (Adulting 101: Life Skills Training). Participants assigned to the intervention arm will participate in 5 half-day, peer-based, interactive sessions teaching community engagement principles. Participants will be assigned to the control arm and will participate in 5 half-day interactive sessions teaching life skills training. 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 community engagement 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 community engagement or life skills training.

The proposed project will use a cluster randomized trial, which 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 Rise Together: Community Engagement Intervention
  The "Rise Together" 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 AYAs community engagement and problem-solving skills through peer relationships. Trained facilitators will lead both didactic and interactive sessions on 1) Community Building, 2) Unpacking Stress and Community Needs, 3) Creating SMART Goals, 4) Researching and Refining S
• Поведенческое Adulting 101: Life Skills
  Adulting 101: Life Skills attention control is a 5-day in-person program that will meet the same number of sessions and duration as the experimental intervention. This attention control is based on the "Project Life" program, which was initially developed 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

Первичные конечные точки

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

Вторичные конечные точки (9)

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

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

Список центров уточняется — проверьте первичный протокол.

Публикации

• 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. PMID 32790447
• Hope EC, Gugwor R, Riddick KN, Pender KN. Engaged Against the Machine: Institutional and Cultural Racial Discrimination and Racial Identity as Predictors of Activism Orientation among Black Youth. Am J Community Psychol. 2019 Mar;63(1-2):61-72. doi: 10.1002/ajcp.12303. Epub 2019 Jan 18. PMID 30659621
• Hope EC, Kornbluh M, Hagan M, Davis AL, Alexander A. Validation of the Black Community Activism Orientation Scale with racially and ethnically diverse college students. Am J Community Psychol. 2023 Mar;71(1-2):79-89. doi: 10.1002/ajcp.12633. Epub 2022 Nov 15. PMID 36378747
• Lewis TT, Cogburn CD, Williams DR. Self-reported experiences of discrimination and health: scientific advances, ongoing controversies, and emerging issues. Annu Rev Clin Psychol. 2015;11:407-40. doi: 10.1146/annurev-clinpsy-032814-112728. Epub 2015 Jan 2. PMID 25581238
• Lockwood KG, Marsland AL, Matthews KA, Gianaros PJ. Perceived discrimination and cardiovascular health disparities: a multisystem review and health neuroscience perspective. Ann N Y Acad Sci. 2018 Sep;1428(1):170-207. doi: 10.1111/nyas.13939. Epub 2018 Aug 8. PMID 30088665
• Ong AD, Williams DR, Nwizu U, Gruenewald TL. Everyday unfair treatment and multisystem biological dysregulation in African American adults. Cultur Divers Ethnic Minor Psychol. 2017 Jan;23(1):27-35. doi: 10.1037/cdp0000087. PMID 28045308
• Paradies Y, Ben J, Denson N, Elias A, Priest N, Pieterse A, Gupta A, Kelaher M, Gee G. Racism as a Determinant of Health: A Systematic Review and Meta-Analysis. PLoS One. 2015 Sep 23;10(9):e0138511. doi: 10.1371/journal.pone.0138511. eCollection 2015. PMID 26398658
• Alegria M, Shrout PE, Canino G, Alvarez K, Wang Y, Bird H, Markle SL, Ramos-Olazagasti M, Rivera DV, Cook BL, Musa GJ, Falgas-Bague I, NeMoyer A, Dominique G, Duarte C. The effect of minority status and social context on the development of depression and anxiety: a longitudinal study of Puerto Rican descent youth. World Psychiatry. 2019 Oct;18(3):298-307. doi: 10.1002/wps.20671. PMID 31496076

Идентификаторы

NCT: NCT07554326 · IRB_2024-6683 · 5R01MD017610-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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