Our Voices Matter: Intervention for Depression in Youth
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age15-20
SponsorAnn & Robert H Lurie Children's Hospital of Chicago
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
15-20 years old
Identify as Black and/ or Latinx
Speak English
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Racial Justice Activism Intervention ARM
BehavioralThe "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.
Adulting 101- Control Arm
BehavioralAdulting 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."
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: RJA Intervention ArmExperimental treatment 1 intervention
Group B: Adulting 101Placebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Depressive Symptoms
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.
Time frame
at baseline and then 0-1-, 6-, 12-, 18-, and 24- months post initial 5 day-intervention2
Metabolic Syndrome
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.)
Time frame
at baseline and then 6-, 12-, and 24- months post initial 5 day-intervention3
Blood Pressure
The investigators will measure systolic and diastolic blood pressure (measured in mmHg) using a size-appropriate blood pressure cuff.
Time frame
at baseline and then 6-, 12-, and 24- months post initial 5 day-intervention4
Triglycerides
The investigators will measure serum triglycerides (mg/dL) as a component of lipid markers.
Time frame
at baseline and then 6-, 12-, and 24- months post initial 5 day-interventionSecondary outcomes
1
Perceived Stress
The investigators will use the Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Short Form on psychological stress experiences to enhance rigor and reproducibility. This tool has acceptable reliability and validity in AYAs. The scoring range is 4-20, with higher scores indicating greater stress severity.
Time frame
at baseline and then 0-1 month, 6-, 12-, 18-, and 24- months post initial 5 day-intervention2
Anxiety
Anxiety will be measured using the Generalized Anxiety Disorder Questionnaire-7 (GAD-7). The GAD-7 has been validated with our study population and is used in clinical practice with an MCID of 4 points on the GAD-7 total score. The scoring is as follows: 0-4: Minimal anxiety, 5-9: Mild anxiety,10-14: Moderate anxiety, and 15-21: Severe anxiety.
Time frame
at baseline and then 0-1 month, 6-, 12-, 18-, and 24- months post initial 5 day-intervention3
Inflammation
The investigators will use biomarkers from inflammatory/immune systems (e.g., Hs-CRP (mg/L), IL-1β (pg/mL), IL-6 (pg/mL), IL-8 (pg/mL), suPAR (pg/mL), and TNF-α (pg/mL). The investigators plan to measure an inflammation score, by standardizing values each biomarker into a z-score, then sum the z-scores to arrive at one reported inflammation score.
Time frame
at baseline and then 6-, 12-, and 24- months post initial 5 day-intervention4
C-Reactive Protein
The investigators will measure Hs-CRP (mg/L) as a measure of inflammation.
Time frame
at baseline and then 6-, 12-, and 24- months post initial 5 day-interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Ann & Robert H Lurie Children's Hospital of Chicago
Lead sponsor
National Institute on Minority Health and Health Disparities (NIMHD)
Collaborator
Policy Research Associates
Collaborator
Source ClinicalTrials.gov