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NCT06821035 · ClinicalTrials.gov registry record · NA
The THRIVE Study: Teaching Healthy Regulation in Individuals & Vulnerable Environments
A NA study of Adverse Childhood Experiences and Family Functioning, sponsored by University of California, Irvine.
- Recruiting
- Registry status
- NA
- Development phase
- 210
- Enrollment target
- 1
- Study location
NCT06821035: Recruiting NA study of Adverse Childhood Experiences and Family Functioning, sponsored by University of California, Irvine.
NCT06821035 is a NA study of Adverse Childhood Experiences and Family Functioning that is actively recruiting participants, run by University of California, Irvine. The registered enrollment target is 210 participants, below the 314-participant average among 13 other Adverse Childhood Experiences trials with a reported enrollment target (33% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06821035, a NA study of Adverse Childhood Experiences and Family Functioning, is actively recruiting participants, sponsored by University of California, Irvine.
- RECRUITING
- Registry status
- NA
- Development phase
- 210 participants
- Enrollment target
- 1
- Study location
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
Primary Outcome
The YRBSS is a multiple-choice survey that collects health behavior history, including questions about alcohol and cannabis use. Youth who report any substance use in the last 30 days on the YRBS will complete the Timeline Followback Method Assessment (TFB) for the last 30 days. The TFB is used to assess recent marijuana, cigarette, alcohol and other drug use. The 14-item self-administered TFB asks respondents to retrospectively estimate their daily drug over a designated period of time, from 7
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 210 participants |
| Start Date | 2025-04-17 |
| Est. Completion | 2028-08-31 |
| Phase | NA |
What NCT06821035 shows while recruiting
NCT06821035 is an interventional study that assigns participants to a tested intervention. The registered 210 participants enrollment target is mid-sized for trials with a published cap, below the 314-participant average among 13 other Adverse Childhood Experiences trials with a reported enrollment target (33% lower).
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.
NCT06821035 reports a single indexed study location in California.
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.
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).
Who is sponsoring clinical trial NCT06821035?
This trial is sponsored by University of California, Irvine, which has 368 total clinical trials registered on ClinicalTrials.gov.
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.
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Where NCT06821035's enrollment target sits among peer trials
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participants (enrollment target), bucketed by value
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