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

Recruiting now · Not applicable

Conditions studied: Adverse Childhood Experiences, Family Functioning

In brief

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

Key facts

Study ID

NCT06821035

Run by

University of California, Irvine

People needed

210

Starts

2025-04-17

Expected to finish

2028-08-31

Last updated by the study team

2026-03-18

Who can join

Age: 11 and older, up to 14. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Youth ages 11-14 years who score in the High-Risk category (i.e., 4 or more ACEs) on the ACEs and Toxic Stress Risk Assessment Algorithm
• Has access to a smartphone and is willing to download applicable apps (95% of all adolescents have access to a smartphone)
• Youth who are able to speak and read in English
• Has a parent/guardian/primary caregiver (18 years or older) who is English- or Spanish-speaking and willing to participate in the intervention.

You may not qualify if…

• Youth who cannot speak and read in English
• Youth who report any alcohol or cannabis use within the last 14 days
• Youth currently enrolled in another family-based intervention (i.e., family therapy)
• Youth in acute distress who are in immediate need of care (e.g., imminent risk of harm to self or others, active psychosis)
• Youth who report their caregivers' home environment is unsafe to return to, have been deemed unsafe, or require supervised visits by the Department of Children and Family Services (DCFS)
• Youth whose parent/guardian/primary caregiver declines participation will be referred to other programs in their community.
• Due to drug experimentation being common in adolescence, our interest in preventing the early initiation of regular use of alcohol and cannabis use, and youth who regularly use substances requiring a different intervention, we will enroll youth who initially report recent cannabis use but later report no use within the last two weeks and have a confirmatory negative urine drug screening.

Where it is running

• The Regents of the University of California, Irvine — Irvine, California, United States (enrolling)

Full record on ClinicalTrials.gov

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