Rise & Thrive: Community-Engagement Intervention for Stress and Depression in Youth.

NCT07554326 | Not Yet Recruiting

• 2 other identifiers: IRB_2024-66835R01MD017610-02
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Depressive Symptoms; Allostatic Load; Metabolic Syndrome

Keywords

mental health; youth intervention; allostatic load; stress; depressive symptoms; depression; metabolic syndrome; prevention

Outcome Measures

Primary Outcomes (9)

• 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 1. a count of the number of signs that meet International Diabetes Federation (IDF) criteria, and 2. 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 Outcomes (9)

• 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

Study Arms (2)

Rise Together: Community Engagement Intervention Arm

EXPERIMENTAL

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

Adulting 101: Life Skills

ACTIVE COMPARATOR

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

Interventions

Rise Together: Community Engagement Intervention BEHAVIORAL

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.

Rise Together: Community Engagement Intervention Arm

Adulting 101: Life Skills BEHAVIORAL

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.

Adulting 101: Life Skills

Eligibility Criteria

• Age: 15 Years - 20 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• years old
• Identify as Black and/ or Hispanic/Latine
• Speak English

You may not qualify if:

• 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 Hispanic/Latine

Sponsors & Collaborators

• Ann & Robert H Lurie Children's Hospital of Chicago: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator
• Policy Research Associates: collaborator

Related Publications (24)

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MeSH Terms

Conditions

Depression; Metabolic Syndrome; Psychological Well-Being

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Personal Satisfaction

Study Officials

• Elan C Hope, PhD

  Policy Research Associates

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nia J Heard Garris, MD, MBA, MSc

CONTACT

3122272664; nheardgarris@luriechildrens.org

Akram Ibrahim, MS

CONTACT

312-227-6944; akibrahim@luriechildrens.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2026
• First Posted: April 28, 2026
• Study Start (Estimated): June 9, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 29, 2028
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• 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.
• 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