Actively Recruiting

Phase Not Applicable
Age: 11Years - 14Years
All Genders
Healthy Volunteers
NCT06821035

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

Led by University of California, Irvine · Updated on 2026-03-18

210

Participants Needed

1

Research Sites

176 weeks

Total Duration

On this page

Sponsors

U

University of California, Irvine

Lead Sponsor

U

University of California, Los Angeles

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 11Years - 14Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Youth ages 11 to 14 years who have four or more adverse childhood experiences (ACEs)
  • Has access to a smartphone and is willing to download apps
  • Youth can speak and read English
  • Has a parent or primary caregiver aged 18 or older who speaks English or Spanish and is willing to participate
Not Eligible

You will not qualify if you...

  • Youth who cannot speak and read English
  • Youth who have used alcohol or cannabis in the past 14 days
  • Youth enrolled in another family-based intervention such as family therapy
  • Youth in acute distress needing immediate care (e.g., risk of harm, active psychosis)
  • Youth whose home environment is unsafe or requires supervised visits by child services
  • Youth whose caregiver declines participation
  • Youth who report recent cannabis use but do not use within the last two weeks and have a negative urine drug test

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

The Regents of the University of California, Irvine

Irvine, California, United States, 92697-7600

Actively Recruiting

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Research Team

D

Dawn T. Bounds, Ph.D.

CONTACT

J

Jenny Fotang

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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