Rise & Thrive: Community-Engagement Intervention for Stress and Depression in Youth. (R&T)

Rise & Thrive: Community-Engagement Intervention to Address Chronic Stress and Prevent Depression in Adolescents and Young Adults

American youth and young adults face persistent and chronic stressors, which have contributed to a mental health crisis in the United States. Four in 10 American high school students experience chronic feelings of sadness and hopelessness, 2 in 10 report suicidal ideation, and 1 in 10 attempt suicide. For adolescents and young adults, chronic stress translates to weathering, or wear and tear on the mind and body. Chronic stress in youth contributes to psychological distress, elevated allostatic load, and an elevated risk for chronic diseases and premature death. While the connection between chronic stress and health is well documented, few studies provide evidence on innovative, non-medication strategies to reduce stress and mitigate the consequences of chronic stress on psychological and physiological outcomes. Thus, there is a critical need to rigorously test interventions that prevent the negative influence of chronic stress on mental and physical health, beginning in adolescence. The specific aims of the study are to 1) Determine whether a community-engagement, peer-based behavioral intervention reduces depressive symptoms in adolescents and young adults, 2) Determine whether a community-engagement behavioral intervention lowers allostatic load scores in adolescents and young adults, and 3) Identify factors that help sustain or inhibit community-engagement and intervention effects for adolescents and young adults. To accomplish these aims, the team will conduct a phase II community-engaged, peer group-based, multi-component randomized behavioral clinical trial. We will collect psychological and physiological measures at baseline, then at 6-month intervals for 2 years post-community-engaged, skills training.

Study Overview

• Status: Not yet recruiting
• Conditions: Metabolic Syndrome; Depressive Symptoms; Allostatic Load
• Intervention / Treatment: Behavioral: Rise Together: Community Engagement Intervention; Behavioral: Adulting 101: Life Skills

Detailed Description

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 (Rise Community Engagement) or control group (Adulting 101: Life Skills Training). Participants assigned to the intervention arm will participate in 5 half-day, peer-based, interactive sessions teaching community engagement principles. Participants will be assigned to the control arm and will participate in 5 half-day interactive sessions teaching life skills training. 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 community engagement 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 community engagement or life skills training.

The proposed project will use a cluster randomized trial, which 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 Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Akram Ibrahim, MS; Phone Number: 312-227-6944; Email: akibrahim@luriechildrens.org
• Study Contact Backup: Name: Nia J Heard Garris, MD, MBA, MSc; Phone Number: 3122272664; Email: nheardgarris@luriechildrens.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. 15-20 years old
2. Identify as Black and/ or Hispanic/Latine
3. Speak English

Exclusion Criteria:

1. Younger than 15 years old, or older than 20 years old
2. Unable to attend the in-person sessions
3. Non-fluent English speaker
4. Do not identify as Black or Hispanic/Latine

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rise Together: Community Engagement Intervention Arm; The "Rise Together" 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 AYAs community engagement and problem-solving skills through peer relationships. Trained facilitators will lead both didactic and interactive sessions on 1) Community Building, 2) Unpacking Stress and Community Needs, 3) Creating SMART Goals, 4) Researching and Refining SMART Goals, 5) Building Your Team, 6) Story Sharing, and 7) Action Planning, focused on community needs and engagement. Participants will learn how to use sources to understand what the community needs (e.g., transportation, healthcare, and education). Participants will analyze policy, develop SMART goals, identify community leaders, and develop plans with peers. Additionally, Rise Together will foster a network of peer support and equip AYAs with community engagement knowledge.	Behavioral: Rise Together: Community Engagement Intervention; The "Rise Together" 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 AYAs community engagement and problem-solving skills through peer relationships. Trained facilitators will lead both didactic and interactive sessions on 1) Community Building, 2) Unpacking Stress and Community Needs, 3) Creating SMART Goals, 4) Researching and Refining SMART Goals, 5) Building Your Team, 6) Story Sharing, and 7) Action Planning, focused on community needs and engagement. Participants will learn how to use sources to understand what the community needs (e.g., transportation, healthcare, and education). Participants will analyze policy, develop SMART goals, identify community leaders, and develop plans with peers. Additionally, Rise Together will foster a network of peer support and equip AYAs with community engagement knowledge.
Active Comparator: Adulting 101: Life Skills; Adulting 101: Life Skills attention control is a 5-day in-person program that will meet the same number of sessions and duration as the experimental intervention. This attention control is based on the "Project Life" program, which was initially developed 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. Participants will learn skills for adulthood and gain experience, developing career and education goals.	Behavioral: Adulting 101: Life Skills; Adulting 101: Life Skills attention control is a 5-day in-person program that will meet the same number of sessions and duration as the experimental intervention. This attention control is based on the "Project Life" program, which was initially developed 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. Participants will learn skills for adulthood and gain experience, developing career and education goals.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.	Time Frame: 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 a 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-intervention
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-intervention.
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-intervention.
High-density lipoprotein	The investigators will measure HDL cholesterol (mg/dL) as a component of lipid markers.	Time Frame: 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.	Time Frame: 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.	Time Frame: 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.	Time Frame: 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.	Time Frame: at baseline and then 6-, 12-, and 24- months post initial 5 day-intervention.

Secondary Outcome Measures

Outcome Measure	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.	Time Frame: 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.	Time Frame: 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.	Time Frame: 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.	Time Frame: 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 a measure of inflammation.	Time Frame: 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.	Time Frame: 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.	Time Frame: 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.	Time Frame: 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.	Time Frame: at baseline and then 6-, 12-, and 24- months post initial 5 day-intervention.

Collaborators and Investigators

• Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD); Policy Research Associates
• Investigators: Principal Investigator: Elan C Hope, PhD, Policy Research Associates

Publications and helpful links

General Publications

• Paradies Y, Ben J, Denson N, Elias A, Priest N, Pieterse A, Gupta A, Kelaher M, Gee G. Racism as a Determinant of Health: A Systematic Review and Meta-Analysis. PLoS One. 2015 Sep 23;10(9):e0138511. doi: 10.1371/journal.pone.0138511. eCollection 2015.
• Lewis TT, Cogburn CD, Williams DR. Self-reported experiences of discrimination and health: scientific advances, ongoing controversies, and emerging issues. Annu Rev Clin Psychol. 2015;11:407-40. doi: 10.1146/annurev-clinpsy-032814-112728. Epub 2015 Jan 2.
• Ong AD, Williams DR, Nwizu U, Gruenewald TL. Everyday unfair treatment and multisystem biological dysregulation in African American adults. Cultur Divers Ethnic Minor Psychol. 2017 Jan;23(1):27-35. doi: 10.1037/cdp0000087.
• 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.
• 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.
• 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.
• Volpe 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.
• Hope 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.
• Cohen 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.
• Ballard 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.
• Heard-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.
• Hope 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.
• Banales 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.
• Lee 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.
• Hill 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.
• Chae 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.
• Adam 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.
• Hicken 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.
• Turan B, Foltz C, Cavanagh JF, Wallace BA, Cullen M, Rosenberg EL, Jennings PA, Ekman P, Kemeny ME. Anticipatory sensitization to repeated stressors: the role of initial cortisol reactivity and meditation/emotion skills training. Psychoneuroendocrinology. 2015 Feb;52:229-38. doi: 10.1016/j.psyneuen.2014.11.014. Epub 2014 Nov 22.
• Alegria M, Shrout PE, Canino G, Alvarez K, Wang Y, Bird H, Markle SL, Ramos-Olazagasti M, Rivera DV, Cook BL, Musa GJ, Falgas-Bague I, NeMoyer A, Dominique G, Duarte C. The effect of minority status and social context on the development of depression and anxiety: a longitudinal study of Puerto Rican descent youth. World Psychiatry. 2019 Oct;18(3):298-307. doi: 10.1002/wps.20671.
• Lockwood KG, Marsland AL, Matthews KA, Gianaros PJ. Perceived discrimination and cardiovascular health disparities: a multisystem review and health neuroscience perspective. Ann N Y Acad Sci. 2018 Sep;1428(1):170-207. doi: 10.1111/nyas.13939. Epub 2018 Aug 8.
• Hope EC, Kornbluh M, Hagan M, Davis AL, Alexander A. Validation of the Black Community Activism Orientation Scale with racially and ethnically diverse college students. Am J Community Psychol. 2023 Mar;71(1-2):79-89. doi: 10.1002/ajcp.12633. Epub 2022 Nov 15.
• Hope EC, Gugwor R, Riddick KN, Pender KN. Engaged Against the Machine: Institutional and Cultural Racial Discrimination and Racial Identity as Predictors of Activism Orientation among Black Youth. Am J Community Psychol. 2019 Mar;63(1-2):61-72. doi: 10.1002/ajcp.12303. Epub 2019 Jan 18.
• Hope EC, Cryer-Coupet QR, Stokes MN. Race-related stress, racial identity, and activism among young Black men: A person-centered approach. Dev Psychol. 2020 Aug;56(8):1484-1495. doi: 10.1037/dev0000836.

Study record dates

Study Major Dates

• Study Start (Estimated): June 9, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 29, 2028

Study Registration Dates

• First Submitted: April 21, 2026
• First Submitted That Met QC Criteria: April 21, 2026
• First Posted (Actual): April 28, 2026

Study Record Updates

• Last Update Posted (Actual): April 28, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: depression; mental health; prevention; stress; metabolic syndrome; depressive symptoms; allostatic load; youth intervention
• Additional Relevant MeSH Terms: Metabolic Diseases; Behavioral Symptoms; Glucose Metabolism Disorders; Insulin Resistance; Hyperinsulinism; Behavior; Nutritional and Metabolic Diseases; Personal Satisfaction; Depression; Metabolic Syndrome; Psychological Well-Being
• Other Study ID Numbers: IRB_2024-6683; 5R01MD017610-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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
• IPD Sharing Time Frame: 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.

IPD Sharing Access Criteria

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:

1. Scientists interested in developing, implementing, and testing activism as an approach to reduce the health risks associated with structural racism, particularly among adolescent and young adult populations. Data and resource sharing with this community will encourage dialogue about the nuances of activism as a youth health intervention, implementation, and evaluation research in youthfocused community settings.
2. Practitioners, clinicians, youth educators, administrators, and other decision-makers, so our findings may be used to inform youth civic education and advocacy programming;
3. The community at large, so adolescents, young adults, and their caregivers and educators can use our findings

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No