Students Rising Above: Offsetting the Health and Mental Health Costs of Resilience

BEHAVIORAL

STRIVE

The STRIVE intervention will include all activities and BREATHE skill training components of L2B with content framed within the needs of high achieving college-bound students who can benefit from health promoting practices to offset the costs of resilience. The intervention will include twelve 60-minute group sessions, with two sessions on each of the six core themes. Each session will include an opening mindful movement, short didactic presentation of the topic or theme of that week, group activities that illustrate the theme, guided discussion about the activity, and in-session group mindfulness meditation practice.

BEHAVIORAL

Study Skills

The sessions will focus on goal setting (4 sessions), organization and time management (3 sessions), and study skills for reading comprehension, writing papers, note-taking, and test-taking (4 sessions). Parallel to the final L2B session, the last meeting will include activities to share and reflect on how students plan to incorporate and sustain new skills.

Change in Internalizing Symptoms over time

Time frame: Collected at baseline, Mid-Assessment (Week 6), Post-Assessment (Week 13), and 12 month follow up

The Depression, Anxiety, Stress Scales (DASS) is a set of three self-report scales designed to measure the negative emotional states of depression, anxiety, and stress. The research team will assess a change in internalizing symptoms at different timepoints. For example, from Baseline to mid-assessment, mid-assessment to post-assessment, baseline to post-assessment, and baseline to 12-month follow up. The minimum score is 0 and the maximum score is 21. Higher scores indicate greater severity of negative emotional symptoms.

Change in Physical Health Complaints over time on the PROMIS scale

Time frame: Collected at baseline, Mid-Assessment (Week 6), Post-Assessment (Week 13), and 12 month follow up

Utilized Two-item Patient Reported Outcomes Measurement and Information System (PROMIS) global physical and mental health scale to measure participant self-reported health. The research team will assess a change in self-reported health at different timepoints. For example, from Baseline to mid-assessment, mid-assessment to post-assessment, baseline to post-assessment, and baseline to 12-month follow up. The overall score is the sum of the two items, the minimum score is 2 and the maximum score is 10. Higher scores reflect better self-reported health.

Change in Physical Health Complaints over time on the CSSI-8

Time frame: Collected at baseline, Mid-Assessment (Week 6), Post-Assessment (Week 13), and 12 month follow up

Utilized the Children's Somatic Symptoms Inventory (CSSI-8) which measures the extent to which youth are bothered by various nonspecific somatic symptoms. The research team will assess a change in internalizing symptoms at different timepoints. For example, from Baseline to mid-assessment, mid-assessment to post-assessment, baseline to post-assessment, and baseline to 12-month follow up. The minimum score is 0 and the maximum score is 32. Higher scores indicate greater somatic distress.

Change in Hair Cortisol over time

Time frame: Collected at baseline, post-assessment (13 weeks), and 12 month follow up

The research team will collect hair samples to measure hair cortisol (picograms per milligram). The research team will assess a change in hair cortisol at different timepoints. For example, from Baseline to post-assessment, post-assessment to 12-month follow up, and baseline to 12-month follow up.

Change in Hair Dehydroepiandrosterone (DHEA) over time

Time frame: Collected at baseline, post-assessment (13 weeks), and 12 month follow up

The research team will collect hair samples to measure hair dehydroepiandrosterone (DHEA) (picograms per milligram). The research team will assess a change in hair DHEA at different timepoints. For example, from Baseline to post-assessment, post-assessment to 12-month follow up, and baseline to 12-month follow up.

Change in Saliva Inflammatory Marker over time

Time frame: Collected at baseline, Post-Assessment (13-weeks), and 12 month follow up

The research team will collect saliva samples from research participants. Interleukin-6 (Il-6) will be assayed from saliva. IL-6 is expressed as pg/ml (picograms per milliliter). The research team will assess a change salivary inflammation levels at different timepoints. For example, from Baseline to post-assessment, post-assessment to 12-month follow up, and baseline to 12-month follow up.

Change in Hip-to-waist ratio

Time frame: Collected at baseline, post-assessment (13 weeks), and 12 month follow up

The research team will collect hip and waist measurements in centimeters (cm). The research team will assess a change in hip-to-waist ratio at different timepoints. For example, from Baseline to post-assessment, post-assessment to 12-month follow up, and baseline to 12-month follow up.

Change in Resting Blood pressure (systolic and diastolic) mmHg (millimeters of mercury)

Time frame: Collected at baseline, post-assessment (13 weeks), and 12 month follow up

The research team will collect resting blood pressure (systolic and diabolic) mmHg (millimeters of mercury). The research team will assess a change in resting blood pressure at different timepoints. For example, from Baseline to post-assessment, post-assessment to 12-month follow up, and baseline to 12-month follow up.

Change in Resting Respiratory Sinus Arrhythmia bpm (beats per minute)

Time frame: Collected at baseline, post-assessment (13 weeks), and 12 month follow up

The research team will collect resting respiratory sinus Arrhythmia bpm. The research team will assess a change in resting respiratory sinus arrhythmia at different timepoints. For example, from Baseline to post-assessment, post-assessment to 12-month follow up, and baseline to 12-month follow up.

Change in Body Mass Index (BMI) Percentile

Time frame: Collected at baseline, post-assessment (13 weeks), and 12 month follow up

The research team will collect weight in kilograms and height in meter to calculate the BMI percentile. Once the BMI is calculated (calculated based on weight in kilograms divided by height in meters), it will be compared to children of the same sex and age. The research team will assess a change in BMI percentiles at different timepoints. For example, from Baseline to post-assessment, post-assessment to 12-month follow up, and baseline to 12-month follow up.

Change in Allostatic Load over time

Time frame: Collected at baseline, Post-Assessment (13-weeks), and 12 month follow up

To calculate allostatic load for each of the indicators (i.e., hair cortisol, hair dehydroepiandrosterone (DHEA), saliva interleukin-6 (Il-6), hip-to-waist ratio, resting blood pressure, Resting Respiratory Sinus Arrhythmia (RSA), and body mass index percentile), participants who score in the 75th percentile will receive a 1, with the exception of RSA and DHEA, where participants will receive a 1 for scores 25th percentile or below. Participants sores will then be summed. Allostatic load scores then could possible range from 0 -6. Higher scores reflect greater allostatic load. The research team will assess a change in allostatic load at different timepoints. For example, from Baseline to post-assessment, post-assessment to 12-month follow up, and baseline to 12-month follow up.

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.