Our Voices Matter: Racial Justice Activism Intervention to Address Structural Racism and Prevent Depression in Black and Latinx Youth
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Glucose
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 15 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •15-20 years old
- •Identify as Black and/ or Latinx
- •Speak English
排除标准
- •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
研究组 & 干预措施
RJA 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 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.
干预措施: Racial Justice Activism Intervention ARM (Behavioral)
Adulting 101
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.
干预措施: Adulting 101- Control Arm (Behavioral)
结局指标
主要结局
Glucose
时间窗: at baseline and then 6-, 12-, and 24- months post initial 5 day-intervention
The investigators will measure fasting glucose (mg/dL) as a marker of metabolic health.
Depressive Symptoms
时间窗: at baseline and then 0-1-, 6-, 12-, 18-, and 24- months post initial 5 day-intervention
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.
Metabolic Syndrome
时间窗: at baseline and then 6-, 12-, and 24- months post initial 5 day-intervention
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.)
Blood Pressure
时间窗: at baseline and then 6-, 12-, and 24- months post initial 5 day-intervention
The investigators will measure systolic and diastolic blood pressure (measured in mmHg) using a size-appropriate blood pressure cuff.
Glycosylated hemoglobin
时间窗: at baseline and then 6-, 12-, and 24- months post initial 5 day-intervention
The investigators will measure HbA1c (mg/dL) as a marker of metabolic health.
Triglycerides
时间窗: at baseline and then 6-, 12-, and 24- months post initial 5 day-intervention
The investigators will measure serum triglycerides (mg/dL) as a component of lipid markers.
High-density lipoprotein
时间窗: at baseline and then 6-, 12-, and 24- months post initial 5 day-intervention
The investigators will measure HDL cholesterol (mg/dL) as a component of lipid markers.
Insulin
时间窗: at baseline and then 6-, 12-, and 24- months post initial 5 day-intervention
The investigators will measure insulin (U/ML) as a marker of metabolic health.
Waist Circumference
时间窗: at baseline and then 6-, 12-, and 24- months post initial 5 day-intervention
The investigators will measure waist circumference (cm) as a marker of metabolic health.
次要结局
- 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)
- Interleukin-6(at baseline and then 6-, 12-, and 24- months post initial 5 day-intervention)
- Interleukin-8(at baseline and then 6-, 12-, and 24- months post initial 5 day-intervention)
- Soluble Urokinase Plasminogen Activator Receptor (suPAR)(at baseline and then 6-, 12-, and 24- months post initial 5 day-intervention)
- Tumor Necrosis Factor alpha (TNF-α)(at baseline and then 6-, 12-, and 24- months post initial 5 day-intervention)
研究者
Nia Heard-Garris
Assistant Professor of Pediatrics
Ann & Robert H Lurie Children's Hospital of Chicago