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NCT Number: NCT07554326

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

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.

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Key information

Conditions

Depressive Symptoms Allostatic Load Behavior Behavioral Symptoms Depression Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Nutritional and Metabolic Diseases Personal Satisfaction Psychological Well-Being

Age range

15 year–20 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 15-20 years old
  • Identify as Black and/ or Hispanic/Latine
  • Speak English

Exclusion criteria

  • 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

Treatment and study plan

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.

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.

Primary outcomes

  1. Depressive Symptoms

    Time frame: 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.

  2. Metabolic Syndrome

    Time frame: 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

    • 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.)

  3. Blood Pressure

    Time frame: 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.

  4. Triglycerides

    Time frame: 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.

  5. High-density lipoprotein

    Time frame: 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.

  6. Glycosylated hemoglobin

    Time frame: 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.

  7. Glucose

    Time frame: 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.

  8. Insulin

    Time frame: 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.

  9. Waist Circumference

    Time frame: 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.

Secondary outcomes

  1. Perceived Stress

    Time frame: Time Frame: at baseline and then 0-1 month, 6-, 12-, 18-, and 24- months post initial 5-day intervention.

    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.

  2. Anxiety

    Time frame: Time Frame: at baseline and then 0-1 month, 6-, 12-, 18-, and 24- months post initial 5-day intervention.

    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.

  3. Inflammation

    Time frame: Time Frame: at baseline and then 6-, 12-, and 24- months post initial 5 day-intervention.

    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.

  4. C-Reactive Protein

    Time frame: Time Frame: at baseline and then 6-, 12-, and 24- months post initial 5 day-intervention.

    The investigators will measure Hs-CRP (mg/L) as a measure of inflammation.

  5. Interleukin-1βeta

    Time frame: Time Frame: at baseline and then 6-, 12-, and 24- months post initial 5 day-intervention

    The investigators will measure IL-1β (pg/mL) as a measure of inflammation.

  6. Interleukin-6

    Time frame: Time Frame: at baseline and then 6-, 12-, and 24- months post initial 5 day-intervention.

    The investigators will measure IL-6 (pg/mL) as a measure of inflammation.

  7. Interleukin-8

    Time frame: Time Frame: at baseline and then 6-, 12-, and 24- months post initial 5 day-intervention.

    The investigators will measure IL-8 (pg/mL) as a measure of inflammation.

  8. Soluble Urokinase Plasminogen Activator Receptor (suPAR)

    Time frame: Time Frame: at baseline and then 6-, 12-, and 24- months post initial 5 day-intervention.

    The investigators will measure suPAR (pg/mL) as a measure of inflammation.

  9. Tumor Necrosis Factor alpha (TNF-α)

    Time frame: Time Frame: at baseline and then 6-, 12-, and 24- months post initial 5 day-intervention.

    The investigators will measure TNF-α (pg/mL) as a measure of inflammation.

Study contacts

Contact information is provided by the study sponsor or research team.

Akram Ibrahim, MS

CONTACT

[email protected]

312-227-6944

Nia J Heard Garris, MD, MBA, MSc

CONTACT

[email protected]

3122272664

Sponsors and collaborators

Lead sponsor

Ann & Robert H Lurie Children's Hospital of Chicago

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)
  • Policy Research Associates

Registry information

Official study title

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

Acronym: R&T

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Apr 28, 2026
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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