The THRIVE Study: Teaching Healthy Regulation in Individuals & Vulnerable Environments
Public ClinicalTrials.gov record NCT06821035. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Teaching Youth & Families Self-Regulation Skills to Disrupt the Impact of Adverse Childhood Experiences: Preventing Substance Use in Adversity- Impacted Youth
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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
Study identification
- NCT ID
- NCT06821035
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 210 participants
Conditions and interventions
Conditions
Interventions
- Garnering Resilience in Traumatized youth and families (GRIT) Behavioral
- Digital Citizenship Curriculum (DCC) Behavioral
Behavioral
Eligibility (public fields only)
- Age range
- 11 Years to 14 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 16, 2025
- Primary completion
- Aug 30, 2028
- Completion
- Aug 30, 2028
- Last update posted
- Mar 17, 2026
2025 – 2028
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| The Regents of the University of California, Irvine | Irvine | California | 92697-7600 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06821035, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 17, 2026 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06821035 live on ClinicalTrials.gov.