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

Part of paid clinical trials in Irvine, California.

Sponsor
University of California, Irvine
Study ID
NCT06821035
Status
Recruiting
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Conditions

  • Adverse Childhood Experiences
  • Family Functioning

Eligibility Criteria

Sex
ALL
Age
11 Years - 14 Years
Healthy Volunteers
Accepted

Interventions

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

Study Details

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 Dates

Start date
Apr 17, 2025
Status verified
Mar 2026
Primary completion
Aug 31, 2028
Completion
Aug 31, 2028

Study Design

Enrollment
210 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: GRIT Intervention
  • Active Comparator: Digital Citizenship Curriculumn

Primary Outcome Measure

Alcohol, Cannabis & Other Substance Use: CDC Youth Risk Behavior Surveillance System (YRBSS)+ Timeline Followback Method Assessment (TFB) [ Time Frame: Baseline, immediately after the intervention, 6 months post-intervention, 12 months post-intervention ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The Regents of the University of California, IrvineIrvineCalifornia92697-7600
Madison Spiva
[email protected]
9498247688
Dawn T. Bounds, Ph.D. (PRINCIPAL_INVESTIGATOR)

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By research site
The Regents of the University of California, Irvine· Irvine, CA

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