Recruiting

Community-Engagement Intervention

Sponsor:

Ann & Robert H Lurie Children's Hospital of Chicago

Code:

NCT07554326

Conditions

Depressive Symptoms

Allostatic Load

Metabolic Syndrome

Eligibility Criteria

Sex: All

Age: 15 - 20

Healthy Volunteers: Accepted

Interventions

Rise Together: Community Engagement Intervention

Adulting 101: Life Skills

Study Details

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

Study ID

NCT07554326

Start date

May 25, 2026

Status verified date

Oct, 2026

Completion date

Dec 29, 2029

Anticipated

Primary completion date

Dec 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 15 - 20

Healthy Volunteers: Accepted

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 Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

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.

Primary outcome measure

  • Depressive Symptoms [ Time Frame: Time Frame: at baseline and then 0-1-, 6-, 12-, 18-, and 24- months post initial 5-day intervention. ]
  • Metabolic Syndrome [ Time Frame: Time Frame: at baseline and then 6-, 12-, and 24- months post initial 5 day-intervention ]
  • Blood Pressure [ Time Frame: Time Frame: at baseline and then 6-, 12-, and 24- months post initial 5 day-intervention. ]
  • Triglycerides [ Time Frame: Time Frame: at baseline and then 6-, 12-, and 24- months post initial 5 day-intervention. ]
  • High-density lipoprotein [ Time Frame: Time Frame: at baseline and then 6-, 12-, and 24- months post initial 5 day-intervention. ]
  • Glycosylated hemoglobin [ Time Frame: Time Frame: at baseline and then 6-, 12-, and 24- months post initial 5 day-intervention. ]
  • Glucose [ Time Frame: Time Frame: at baseline and then 6-, 12-, and 24- months post initial 5 day-intervention. ]
  • Insulin [ Time Frame: Time Frame: at baseline and then 6-, 12-, and 24- months post initial 5 day-intervention. ]
  • Waist Circumference [ Time Frame: Time Frame: at baseline and then 6-, 12-, and 24- months post initial 5 day-intervention. ]

Central Contacts and Locations

Central contacts

Locations

Ann & Robert H. Lurie Children's Hospital of Chicago

Recruiting

Chicago, Illinois, United States, 60611

Contacts

More Information

Sponsor

Ann & Robert H Lurie Children's Hospital of Chicago

Last update posted

Oct 21, 2026

Last verified

Oct, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-22. This information was provided to ClinicalTrials.gov by Ann & Robert H Lurie Children's Hospital of Chicago on 2026-10-21. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.