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RECRUITING NA

The THRIVE Study: Teaching Healthy Regulation in Individuals & Vulnerable Environments

NCT06821035 · View on ClinicalTrials.gov ↗

Study 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

Interventions

  • BEHAVIORAL Garnering Resilience in Traumatized youth and families (GRIT)
  • BEHAVIORAL Digital Citizenship Curriculum (DCC)

Study Locations (1)

California

  • The Regents of the University of California, Irvine — Irvine

Trial Details

FieldValue
Enrollment Target 210 participants
Start Date 2025-04-17
Est. Completion 2028-08-31
Phase NA

Sponsor

University of California, Irvine

353 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06821035

The ClinicalTrials.gov registry entry for NCT06821035 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 210 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, Irvine, which has 353 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Adverse Childhood Experiences appearing as the primary indexed condition, and to 2 interventions — of which Garnering Resilience in Traumatized youth and families (GRIT) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06821035 reports 1 study location spanning 1 distinct geographic area — top geographies include California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06821035 about?

NCT06821035 is a clinical study titled "The THRIVE Study: Teaching Healthy Regulation in Individuals & Vulnerable Environments". 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...

What is the current status of trial NCT06821035?

This trial is currently recruiting. It is a NA study. The enrollment target is 210 participants. The study started on 2025-04-17. Estimated completion is 2028-08-31.

What conditions does trial NCT06821035 study?

This clinical trial studies the following conditions: Adverse Childhood Experiences, Family Functioning. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06821035?

The interventions under investigation include: Garnering Resilience in Traumatized youth and families (GRIT) (BEHAVIORAL), Digital Citizenship Curriculum (DCC) (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06821035?

This trial is sponsored by University of California, Irvine, which has 353 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06821035 being conducted?

This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial