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

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

Conditions

• Adverse Childhood Experiences
• Family Functioning

Interventions

BEHAVIORAL

Garnering 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.

BEHAVIORAL

Digital 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.

Sponsors & Collaborators

• University of California, Los Angeles

  collaborator OTHER

• University of Illinois at Chicago

  collaborator OTHER

• National Institute on Drug Abuse (NIDA)

  collaborator NIH

• University of California, Irvine

  lead OTHER

Principal Investigators

• Dawn T. Bounds, Ph.D. · University of California, Irvine

• Norweeta G. Milburn, Ph.D. · University of California, Los Angeles

• Karnik Niranjan, M.D., Ph.D. · University of California, Los Angeles

• Shin Sanghyuk, Ph.D. · University of California, Irvine

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

11 Years

Max Age

14 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-04-17

Primary Completion

2028-08-31

Completion

2028-08-31

Countries

• United States

Study Locations