RecruitingNot ApplicableNCT06821035

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

Teaching Youth & Families Self-Regulation Skills to Disrupt the Impact of Adverse Childhood Experiences: Preventing Substance Use in Adversity- Impacted Youth


Sponsor

University of California, Irvine

Enrollment

210 participants

Start Date

Apr 17, 2025

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 11 YearsMax Age: 14 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a behavioral approach called Digital Citizenship Curriculum (DCC) and a behavioral approach called Garnering Resilience in Traumatized youth and families (GRIT) for people with adverse childhood experiences and family functioning. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALGarnering Resilience in Traumatized youth and families (GRIT)

Dyads randomly assigned to Garnering Resilience in Traumatized youth and families (GRIT) will receive a community health worker delivered psychoeducational intervention that includes 6 weekly sessions focused on: 1) supportive health coaching to garner resilience via psychoeducation and the promotion of buffering protective factors in both youth and caregivers and 2) facilitating self-regulation using heart rate variability (HRV) biofeedback.

BEHAVIORALDigital Citizenship Curriculum (DCC)

Dyads randomly assigned to DCC will receive a community health worker-delivered, school grade-specific intervention that includes 6 weekly sessions focused on helping youth navigate the complexities of living in a digital world.


Locations(1)

The Regents of the University of California, Irvine

Irvine, California, United States

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NCT06821035


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