Rise & Thrive: Community-Engagement Intervention to Address Chronic Stress and Prevent Depression in Adolescents and Young Adults
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 300
- 主要终点
- Depressive Symptoms
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 15 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •15-20 years old
- •Identify as Black and/ or Hispanic/Latine
- •Speak English
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Rise Together: Community Engagement Intervention (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.
干预措施: Adulting 101: Life Skills (Behavioral)
结局指标
主要结局
Depressive Symptoms
时间窗: 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.
Metabolic Syndrome
时间窗: 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 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.)
Blood Pressure
时间窗: 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.
Triglycerides
时间窗: 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.
High-density lipoprotein
时间窗: 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.
Glycosylated hemoglobin
时间窗: 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.
Glucose
时间窗: 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.
Insulin
时间窗: 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.
Waist Circumference
时间窗: 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.
次要结局
- 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)
- Interleukin-6(Time Frame: at baseline and then 6-, 12-, and 24- months post initial 5 day-intervention.)
- Interleukin-8(Time Frame: at baseline and then 6-, 12-, and 24- months post initial 5 day-intervention.)
- Soluble Urokinase Plasminogen Activator Receptor (suPAR)(Time Frame: at baseline and then 6-, 12-, and 24- months post initial 5 day-intervention.)
- Tumor Necrosis Factor alpha (TNF-α)(Time Frame: at baseline and then 6-, 12-, and 24- months post initial 5 day-intervention.)