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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age15-20
SponsorAnn & Robert H Lurie Children's Hospital of Chicago

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

15-20 years old

Identify as Black and/ or Hispanic/Latine

Speak English

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: Rise Together: Community Engagement Intervention ArmExperimental treatment 1 intervention
Group B: Adulting 101: Life SkillsActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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
Time Frame: at baseline and then 0-1-, 6-, 12-, 18-, and 24- months post initial 5-day intervention.
2

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
Time Frame: at baseline and then 6-, 12-, and 24- months post initial 5 day-intervention
3

Blood Pressure

The investigators will measure systolic and diastolic blood pressure (measured in mmHg) using a size-appropriate blood pressure cuff.

Time frame
Time Frame: at baseline and then 6-, 12-, and 24- months post initial 5 day-intervention.
4

Triglycerides

The investigators will measure serum triglycerides (mg/dL) as a component of lipid markers.

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

Secondary outcomes

1

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
Time Frame: at baseline and then 0-1 month, 6-, 12-, 18-, and 24- months post initial 5-day intervention.
2

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
Time Frame: at baseline and then 0-1 month, 6-, 12-, 18-, and 24- months post initial 5-day intervention.
3

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
Time Frame: at baseline and then 6-, 12-, and 24- months post initial 5 day-intervention.
4

C-Reactive Protein

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

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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Ann & Robert H Lurie Children's Hospital of Chicago

Lead sponsor

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Policy Research Associates

Collaborator

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