The THRIVE Study: Teaching Healthy Regulation in Individuals & Vulnerable Environments (NCT06821035)
Teaching Youth & Families Self-Regulation Skills to Disrupt the Impact of Adverse Childhood Experiences: Preventing Substance Use in Adversity- Impacted Youth
🩺 Plain-English Summary (8th-Grade Level)
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 join: Review the eligibility criteria below.
Location: The Regents of the University of California, Irvine — Irvine, California
Age range: 11 Years to 14 Years
🧪 Interventions in This Study
- Garnering Resilience in Traumatized youth and families (GRIT) (BEHAVIORAL)
- Digital Citizenship Curriculum (DCC) (BEHAVIORAL)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- The Regents of the University of California, Irvine — Irvine, California
📞 Contact the Study Coordinator
Phone: (949) 742-7109
Email: boundsd@hs.uci.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Adverse Childhood Experiences
- Playing Playfully to Overcome Adversity — Fairfield, Connecticut
- Childhood Trauma, Exercise, and Cognition — Austin, Texas
- ACEs, SIRT1, and Premature Vascular Aging in Humans — Iowa City, Iowa
- Building Resilient Families — Loma Linda, California
- Neurobehavioral Mechanisms Linking Childhood Adversity to Increased Risk for Smoking — Durham, North Carolina
Explore by condition: All Adverse Childhood Experiences clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.