The THRIVE Study: Teaching Healthy Regulation in Individuals & Vulnerable Environments (NCT06821035) | Clinical Trial Compass
RecruitingNot Applicable
The THRIVE Study: Teaching Healthy Regulation in Individuals & Vulnerable Environments
United States210 participantsStarted 2025-04-17
Plain-language summary
The goal of this 2-arm randomized control trial is to determine the impact of a community health worker delivered coaching intervention, GRIT, on preventing the early initiation of regular use of alcohol and cannabis among adversity-impacted adolescents ages 11-14 who do not regularly use alcohol or cannabis at baseline. The specific aims include:
* Aim 1. Examine the effect of GRIT on preventing the early initiation of regular alcohol and cannabis use over time.
* Aim 2. Examine the role of youth and caregiver self-regulation in mediating the effect of GRIT on adolescent rates of alcohol and cannabis use.
Researchers will compare participants who are randomized to the GRIT intervention to an active control group, receiving a Digital Citizenship Curriculum, to see if those who participate in GRIT experience greater improvements in self-regulation and lower cardiometabolic risks.
Participants will:
* Be randomized to either receive the GRIT intervention (experimental group) or the Digital Citizenship Curriculum (active control group)
* Complete 3 in-person visits at baseline, post-intervention, and 12-month post intervention
* Complete HRV assessments using emWave Pro Plus and survey assessments on REDCap during in-person visits.
* Participate in six 60-minute sessions conducted over 8 weeks via Zoom with an assigned community-health worker
* Be invited to complete a booster session at 6-months post-intervention
* Complete online measures at baseline, post-intervention, 6-month, and 12-month post-intervention
Who can participate
Age range
11 Years – 14 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Youth ages 11-14 years who score in the High-Risk category (i.e., 4 or more ACEs) on the ACEs and Toxic Stress Risk Assessment Algorithm
* Has access to a smartphone and is willing to download applicable apps (95% of all adolescents have access to a smartphone)
* Youth who are able to speak and read in English
* Has a parent/guardian/primary caregiver (18 years or older) who is English- or Spanish-speaking and willing to participate in the intervention.
Exclusion Criteria:
* Youth who cannot speak and read in English
* Youth who report any alcohol or cannabis use within the last 14 days
* Youth currently enrolled in another family-based intervention (i.e., family therapy)
* Youth in acute distress who are in immediate need of care (e.g., imminent risk of harm to self or others, active psychosis)
* Youth who report their caregivers' home environment is unsafe to return to, have been deemed unsafe, or require supervised visits by the Department of Children and Family Services (DCFS)
* Youth whose parent/guardian/primary caregiver declines participation will be referred to other programs in their community.
* Due to drug experimentation being common in adolescence, our interest in preventing the early initiation of regular use of alcohol and cannabis use, and youth who regularly use substances requiring a different intervention, we will enroll youth who initially report recent cannabis use but later report no use within the last two weeks and have a conf…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Alcohol, Cannabis & Other Substance Use: CDC Youth Risk Behavior Surveillance System (YRBSS)+ Timeline Followback Method Assessment (TFB)
Timeframe: Baseline, immediately after the intervention, 6 months post-intervention, 12 months post-intervention
2
Emotional Regulation: Difficulties in Emotional Regulation- Short Form (DERS-SF)
Timeframe: Baseline, immediately after the intervention, 6 months post-intervention, 12 months post-intervention