Our Voices Matter: Intervention for Depression in Youth

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 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.

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-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."

Depressive Symptoms

Time frame: 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

Time frame: 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

Time frame: 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.

Triglycerides

Time frame: 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

Time frame: 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.

Glycosylated hemoglobin

Time frame: 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.

Glucose

Time frame: 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.

Insulin

Time frame: 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

Time frame: 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.

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.