Depressive SymptomsOVMNCT07216326
Our Voices Matter: Intervention for Depression in Youth
A study testing Racial Justice Activism Intervention ARM in people with Depressive Symptoms and Allostatic Load, run by Ann & Robert H Lurie Children's Hospital of Chicago at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 15 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Depressive Symptoms, Allostatic Load, Metabolic Syndrome
- What is being tested?
- Racial Justice Activism Intervention ARM
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jun 2025to 29 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 15-20 years old
- Identify as Black and/ or Latinx
- Speak English
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
About this study
Official title: Our Voices Matter: Racial Justice Activism Intervention to Address Structural Racism and Prevent Depression in Black and Latinx Youth
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.
Read the 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 (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.
- Conditions
- Depressive Symptoms, Allostatic Load, Metabolic Syndrome
- Being tested
- Racial Justice Activism Intervention ARM, Adulting 101- Control Arm
- Keywords
- mental health, youth intervention, allostatic load, stress, depressive symptoms, depression, metabolic syndrome, prevention, inflammation
- Medical subject headings
- Depression, Metabolic Syndrome, Psychological Well-Being, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Racial Justice Activism Intervention ARMBehavioural
Also called 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 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 ArmBehavioural
Also called Adulting/RJA Control
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."
| Study group | Role | What they receive |
|---|---|---|
| RJA Intervention Arm | Experimental | 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. Receives: Behavioral: Racial Justice Activism Intervention ARM |
| Adulting 101 | Placebo comparator | 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. Receives: Behavioral: Adulting 101- Control Arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at baseline and then 0-1-, 6-, 12-, 18-, and 24- months post initial 5 day-intervention
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
- a count of the number of signs that meet International Diabetes Federation (IDF) criteria, and
- 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.)
Measured: at baseline and then 6-, 12-, and 24- months post initial 5 day-intervention
Blood Pressure
The investigators will measure systolic and diastolic blood pressure (measured in mmHg) using a size-appropriate blood pressure cuff.
Measured: at baseline and then 6-, 12-, and 24- months post initial 5 day-intervention
Triglycerides
The investigators will measure serum triglycerides (mg/dL) as a component of lipid markers.
Measured: at baseline and then 6-, 12-, and 24- months post initial 5 day-intervention
High-density lipoprotein
The investigators will measure HDL cholesterol (mg/dL) as a component of lipid markers.
Measured: at baseline and then 6-, 12-, and 24- months post initial 5 day-intervention
Glycosylated hemoglobin
The investigators will measure HbA1c (mg/dL) as a marker of metabolic health.
Measured: at baseline and then 6-, 12-, and 24- months post initial 5 day-intervention
Glucose
The investigators will measure fasting glucose (mg/dL) as a marker of metabolic health.
Measured: at baseline and then 6-, 12-, and 24- months post initial 5 day-intervention
Insulin
The investigators will measure insulin (U/ML) as a marker of metabolic health.
Measured: at baseline and then 6-, 12-, and 24- months post initial 5 day-intervention
Waist Circumference
The investigators will measure waist circumference (cm) as a marker of metabolic health.
Measured: at baseline and then 6-, 12-, and 24- months post initial 5 day-intervention
Secondary outcomes (9)
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.
Measured: at baseline and then 0-1 month, 6-, 12-, 18-, and 24- months post initial 5 day-intervention
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.
Measured: at baseline and then 0-1 month, 6-, 12-, 18-, and 24- months post initial 5 day-intervention
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.
Measured: at baseline and then 6-, 12-, and 24- months post initial 5 day-intervention
C-Reactive Protein
The investigators will measure Hs-CRP (mg/L) as a measure of inflammation.
Measured: at baseline and then 6-, 12-, and 24- months post initial 5 day-intervention
Interleukin-1βeta
The investigators will measure IL-1β (pg/mL) as measure of inflammation.
Measured: at baseline and then 6-, 12-, and 24- months post initial 5 day-intervention
Interleukin-6
The investigators will measure IL-6 (pg/mL) as a measure of inflammation.
Measured: at baseline and then 6-, 12-, and 24- months post initial 5 day-intervention
Interleukin-8
The investigators will measure IL-8 (pg/mL) as a measure of inflammation.
Measured: at baseline and then 6-, 12-, and 24- months post initial 5 day-intervention
Soluble Urokinase Plasminogen Activator Receptor (suPAR)
The investigators will measure suPAR (pg/mL) as a measure of inflammation.
Measured: at baseline and then 6-, 12-, and 24- months post initial 5 day-intervention
Tumor Necrosis Factor alpha (TNF-α)
The investigators will measure TNF-α (pg/mL) as a measure of inflammation.
Measured: at baseline and then 6-, 12-, and 24- months post initial 5 day-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2025
- Study start6 Jun 2025
- Primary completion1 Dec 2028 (estimated)
- Study completion29 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for Depressive SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD), Policy Research Associates
- Responsible party
- Principal investigator, Nia Heard-Garris, Ann & Robert H Lurie Children's Hospital of Chicago
- Investigators
- Elan C Hope, PhD, Principal investigator, Policy Research Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07216326
- Sponsor's protocol ID
- IRB 2024-6683
- Other IDs
- 1R01MD017610-01A1
- Acronym
- OVM
- Status last verified
- Jun 2026
- First submitted
- 9 Dec 2024
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Northwestern Univ. (NU) and Lurie Children's (LCH) are committed to the open and timely dissemination of all research outcomes through the development of repositories and databases, posting of data on open websites, presentations, and through publications as soon as is feasible after peer review. Team will assure the confidentiality of all human subjects' data and will adhere to all HIPAA rules to ensure compliance with human subject confidentiality requirements. Collaborators will ensure that any data obtained as a part of the awarded grant will be made available to collaborators and to the general research community through databases and public repositories and by publishing in printed or electronic form as soon as practically possible after the data have been obtained and peer-reviewed. Team agrees to publish all data derived from this award in a timely fashion and to make those data freely available via web postings whenever possible. All data will be made available after 1 year.
Publications
Pinedo A, Durkee MI, Diemer MA, Hope EC. Disentangling longitudinal trajectories of racial discrimination and critical action among Black and Latinx college students: What role do peers play? Cultur Divers Ethnic Minor Psychol. 2021 Jul;27(3):546-557. doi: 10.1037/cdp0000434. Epub 2021 Apr 29.
PubMed 33914581Volpe 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.
PubMed 34419231Gaydosh L, Schorpp KM, Chen E, Miller GE, Harris KM. College completion predicts lower depression but higher metabolic syndrome among disadvantaged minorities in young adulthood. Proc Natl Acad Sci U S A. 2018 Jan 2;115(1):109-114. doi: 10.1073/pnas.1714616114. Epub 2017 Dec 18.
PubMed 29255040Volpe VV, Lee DB, Hoggard LS, Rahal D. Racial Discrimination and Acute Physiological Responses Among Black Young Adults: The Role of Racial Identity. J Adolesc Health. 2019 Feb;64(2):179-185. doi: 10.1016/j.jadohealth.2018.09.004. Epub 2018 Nov 6.
PubMed 30409752Hope 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.
PubMed 34338546Cohen 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.
PubMed 33612361Ballard PJ, Syme SL. Engaging youth in communities: a framework for promoting adolescent and community health. J Epidemiol Community Health. 2016 Feb;70(2):202-6. doi: 10.1136/jech-2015-206110. Epub 2015 Oct 6.
PubMed 26443541Heard-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.
PubMed 34129023Hope EC, Velez G, Offidani-Bertrand C, Keels M, Durkee MI. Political activism and mental health among Black and Latinx college students. Cultur Divers Ethnic Minor Psychol. 2018 Jan;24(1):26-39. doi: 10.1037/cdp0000144. Epub 2017 Jun 26.
PubMed 28650179Banales J, Aldana A, Richards-Schuster K, Flanagan CA, Diemer MA, Rowley SJ. Youth anti-racism action: Contributions of youth perceptions of school racial messages and critical consciousness. J Community Psychol. 2021 Nov;49(8):3079-3100. doi: 10.1002/jcop.22266. Epub 2019 Nov 6.
PubMed 31691984Lee DB, Peckins MK, Heinze JE, Miller AL, Assari S, Zimmerman MA. Psychological pathways from racial discrimination to cortisol in African American males and females. J Behav Med. 2018 Apr;41(2):208-220. doi: 10.1007/s10865-017-9887-2. Epub 2017 Sep 23.
PubMed 28942527Hill LK, Hoggard LS, Richmond AS, Gray DL, Williams DP, Thayer JF. Examining the association between perceived discrimination and heart rate variability in African Americans. Cultur Divers Ethnic Minor Psychol. 2017 Jan;23(1):5-14. doi: 10.1037/cdp0000076.
PubMed 28045306Chae DH, Nuru-Jeter AM, Adler NE, Brody GH, Lin J, Blackburn EH, Epel ES. Discrimination, racial bias, and telomere length in African-American men. Am J Prev Med. 2014 Feb;46(2):103-11. doi: 10.1016/j.amepre.2013.10.020.
PubMed 24439343Adam EK, Heissel JA, Zeiders KH, Richeson JA, Ross EC, Ehrlich KB, Levy DJ, Kemeny M, Brodish AB, Malanchuk O, Peck SC, Fuller-Rowell TE, Eccles JS. Developmental histories of perceived racial discrimination and diurnal cortisol profiles in adulthood: A 20-year prospective study. Psychoneuroendocrinology. 2015 Dec;62:279-91. doi: 10.1016/j.psyneuen.2015.08.018. Epub 2015 Aug 28.
PubMed 26352481Hicken MT, Lee H, Ailshire J, Burgard SA, Williams DR. "Every shut eye, ain't sleep": The role of racism-related vigilance in racial/ethnic disparities in sleep difficulty. Race Soc Probl. 2013 Jun 1;5(2):100-112. doi: 10.1007/s12552-013-9095-9.
PubMed 23894254
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Our Voices Matter: Racial Justice Activism Intervention to Address Structural Racism and Prevent Depression in Black and Latinx Youth
- ClinicalTrials.gov ID
- NCT07216326
- Acronym / sponsor ID
- OVM / IRB 2024-6683
- Conditions
- Depressive Symptoms, Allostatic Load, Metabolic Syndrome
- Keywords
- mental health, youth intervention, allostatic load, stress, depressive symptoms, depression, metabolic syndrome, prevention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of ChicagoUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD), Policy Research Associates
- Study start
- 6 Jun 2025 (actual)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 29 Dec 2028 (estimated)
- First posted
- 14 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 (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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RJA Intervention Arm | Experimental | Behavioral: Racial Justice Activism Intervention ARMThe "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. |
| Adulting 101 | Placebo comparator | Behavioral: Adulting 101- Control ArmAdulting 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. |
Who may qualify
- Ages
- 15 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 15-20 years old
- Identify as Black and/ or Latinx
- Speak English
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Racial Justice Activism Intervention ARMAlso: RJA Intervention ARMThe "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. | Behavioural | RJA Intervention Arm |
| Adulting 101- Control ArmAlso: Adulting/RJA ControlAdulting 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." | Behavioural | Adulting 101 |
Primary outcome
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.
9 secondary outcomes
Perceived Stress
Time frame: at baseline and then 0-1 month, 6-, 12-, 18-, and 24- months post initial 5 day-intervention
Anxiety
Time frame: at baseline and then 0-1 month, 6-, 12-, 18-, and 24- months post initial 5 day-intervention
Inflammation
Time frame: at baseline and then 6-, 12-, and 24- months post initial 5 day-intervention
C-Reactive Protein
Time frame: at baseline and then 6-, 12-, and 24- months post initial 5 day-intervention
Interleukin-1βeta
Time frame: at baseline and then 6-, 12-, and 24- months post initial 5 day-intervention
Interleukin-6
Time frame: at baseline and then 6-, 12-, and 24- months post initial 5 day-intervention
Interleukin-8
Time frame: at baseline and then 6-, 12-, and 24- months post initial 5 day-intervention
Soluble Urokinase Plasminogen Activator Receptor (suPAR)
Time frame: at baseline and then 6-, 12-, and 24- months post initial 5 day-intervention
Tumor Necrosis Factor alpha (TNF-α)
Time frame: at baseline and then 6-, 12-, and 24- months post initial 5 day-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Background: PubMed 33914581Pinedo A, Durkee MI, Diemer MA, Hope EC. Disentangling longitudinal trajectories of racial discrimination and critical action among Black and Latinx college students: What role do peers play? Cultur Divers Ethnic Minor Psychol. 2021 Jul;27(3):546-557. doi: 10.1037/cdp0000434. Epub 2021 Apr 29.
- Background: PubMed 34419231Volpe 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.
- Background: PubMed 29255040Gaydosh L, Schorpp KM, Chen E, Miller GE, Harris KM. College completion predicts lower depression but higher metabolic syndrome among disadvantaged minorities in young adulthood. Proc Natl Acad Sci U S A. 2018 Jan 2;115(1):109-114. doi: 10.1073/pnas.1714616114. Epub 2017 Dec 18.
- Background: PubMed 30409752Volpe VV, Lee DB, Hoggard LS, Rahal D. Racial Discrimination and Acute Physiological Responses Among Black Young Adults: The Role of Racial Identity. J Adolesc Health. 2019 Feb;64(2):179-185. doi: 10.1016/j.jadohealth.2018.09.004. Epub 2018 Nov 6.
- Background: PubMed 34338546Hope 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.
- Background: PubMed 33612361Cohen 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.
- Background: PubMed 26443541Ballard PJ, Syme SL. Engaging youth in communities: a framework for promoting adolescent and community health. J Epidemiol Community Health. 2016 Feb;70(2):202-6. doi: 10.1136/jech-2015-206110. Epub 2015 Oct 6.
- Background: PubMed 34129023Heard-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.
- Background: PubMed 28650179Hope EC, Velez G, Offidani-Bertrand C, Keels M, Durkee MI. Political activism and mental health among Black and Latinx college students. Cultur Divers Ethnic Minor Psychol. 2018 Jan;24(1):26-39. doi: 10.1037/cdp0000144. Epub 2017 Jun 26.
- Background: PubMed 31691984Banales J, Aldana A, Richards-Schuster K, Flanagan CA, Diemer MA, Rowley SJ. Youth anti-racism action: Contributions of youth perceptions of school racial messages and critical consciousness. J Community Psychol. 2021 Nov;49(8):3079-3100. doi: 10.1002/jcop.22266. Epub 2019 Nov 6.
- Background: PubMed 28942527Lee DB, Peckins MK, Heinze JE, Miller AL, Assari S, Zimmerman MA. Psychological pathways from racial discrimination to cortisol in African American males and females. J Behav Med. 2018 Apr;41(2):208-220. doi: 10.1007/s10865-017-9887-2. Epub 2017 Sep 23.
- Background: PubMed 28045306Hill LK, Hoggard LS, Richmond AS, Gray DL, Williams DP, Thayer JF. Examining the association between perceived discrimination and heart rate variability in African Americans. Cultur Divers Ethnic Minor Psychol. 2017 Jan;23(1):5-14. doi: 10.1037/cdp0000076.
- Individual participant dataSharing planned: Yes. Northwestern Univ. (NU) and Lurie Children's (LCH) are committed to the open and timely dissemination of all research outcomes through the development of repositories and databases, posting of data on open websites, presentations, and through publications as soon as is feasible after peer review. Team will assure the confidentiality of all human subjects' data and will adhere to all HIPAA rules to ensure compliance with human subject confidentiality requirements. Collaborators will ensure that any data obtained as a part of the awarded grant will be made available to collaborators and to the general research community through databases and public repositories and by publishing in printed or electronic form as soon as practically possible after the data have been obtained and peer-reviewed. Team agrees to publish all data derived from this award in a timely fashion and to make those data freely available via web postings whenever possible. All data will be made available after 1 year.
Related trials for Depressive Symptoms
RecruitingPhase 2
Psilocybin-assisted Therapy for Comorbid Major Depressive Disorder and Alcohol Use Disorder
Major Depressive Disorder (MDD), Alcohol Use Disorder (AUD)
RecruitingPhase 1
Neuropharmacologic Imaging and Biomarker Assessments of Response to Acute and Repeated-Dosed Ketamine Infusions in Major Depressive Disorder
Healthy Volunteer, Major Depressive Disorder
RecruitingPhase 1
Effects of Intranasal Oxytocin in Patients With Arginine-vasopressin Deficiency
Vasopressin Deficiency
Recruiting
Psychopharmacotherapy for Depressive Patients
Major Depressive Disorder
RecruitingObservational study
Characterization and Treatment of Adolescent Depression
Depression
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elan C Hope, PhD principal investigator
Policy Research Associates
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Racial Justice Activism Intervention ARM in people with Depressive Symptoms and Allostatic Load, run by Ann & Robert H Lurie Children's Hospital of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nia Heard-Garris, MD, MBA, MSc (3122272664, nheardgarris@luriechildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depressive Symptoms (time frame: at baseline and then 0-1-, 6-, 12-, 18-, and 24- months post initial 5 day-intervention). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07216326, which also lists 30 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.