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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01MD017610-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
| Policy Research Associates | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Racial Justice Activism Intervention ARM | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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
| 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. | at baseline and then 6-, 12-, and 24- months post initial 5 day-intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | at baseline and then 0-1 month, 6-, 12-, 18-, and 24- months post initial 5 day-intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nia Heard-Garris, MD, MBA, MSc | Contact | 3122272664 | nheardgarris@luriechildrens.org | |
| Akram Ibrahim, MS | Contact | 312-227-6944 | akibrahim@luriechildrens.org |
| Name | Affiliation | Role |
|---|---|---|
| Elan C Hope, PhD | Policy Research Associates | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ann & Robert H. Lurie Children's Hospital of Chicago | Recruiting | Chicago | Illinois | 60611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33914581 | Background | 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. | |
| 34419231 | Background | Volpe 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. |
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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.
Research data will be made publicly available through posting on open websites, presentations, and peer-reviewed publications (in some cases after an embargo period not to exceed one year). Inventions appropriate for commercialization will be protected via intellectual property (IP) filings, commercialized, and provided to society as products or services by or through the Innovation and New Ventures Office, NU's technology transfer office. Innovation and New Ventures Office manages NU's invention disclosure, assessment, patenting, and marketing processes. NU is committed to the free exchange of data and resources and for the rapid commercialization of biomedical inventions for the benefit of the public, consistent with the terms of the Bayh-Dole Act. NU's commercialization practices to date have maximized the public benefit of inventions arising from federal funding by providing useful, commercially relevant, and available products and services.
Data and resource sharing is an essential to the study activities. The team will share the data and resources generated by this project by making our findings, intervention materials and protocols (e.g., training materials, manuals, etc.), available to the following communities:
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| ID | Term |
|---|---|
| D003863 | Depression |
| D024821 | Metabolic Syndrome |
| D000092862 | Psychological Well-Being |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
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|
| Adulting 101- Control Arm | Behavioral | 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." |
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| Triglycerides | The investigators will measure serum triglycerides (mg/dL) as a component of lipid markers. | 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. | 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. | 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. | 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. | 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. | at baseline and then 6-, 12-, 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | at baseline and then 6-, 12-, and 24- months post initial 5 day-intervention |
| 29255040 | Background | Gaydosh 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. |
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| D044882 |
| Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D010549 | Personal Satisfaction |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |