Recruiting

Observational StudyThe THRIVE Study: Teaching Healthy Regulation in Individuals & Vulnerable Environments

Sponsor:

UCLA

Code:

NCT06821035

Conditions

Adverse Childhood Experiences

Family Functioning

Eligibility Criteria

Sex: All

Age: 11 - 14

Healthy Volunteers: Accepted

Interventions

Garnering Resilience in Traumatized youth and families (GRIT)

Digital Citizenship Curriculum (DCC)

Study Details

Brief 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

Study ID

NCT06821035

Start date

Apr 17, 2025

Status verified date

Mar, 2026

Completion date

Aug 31, 2028

Anticipated

Primary completion date

Aug 31, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 11 - 14

Healthy Volunteers: Accepted

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Study Design

Enrollment

210 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: GRIT Intervention

active comparator: Digital Citizenship Curriculumn

Interventions

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.

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.

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 ]
Emotional Regulation: Difficulties in Emotional Regulation- Short Form (DERS-SF) [ Time Frame: Baseline, immediately after the intervention, 6 months post-intervention, 12 months post-intervention ]

Central Contacts and Locations

Central contacts

Dawn T. Bounds, Ph.D.

949-742-7109 boundsd@hs.uci.edu

Jenny Fotang

949-516-1694 jfotang@hs.uci.edu

Locations

The Regents of the University of California, Irvine

Recruiting

Irvine, California, United States, 92697-7600

Contacts

Madison Spiva

9498247688 mspiva@uci.edu

Principal Investigator:

Dawn T. Bounds, Ph.D.

More Information

Sponsor

University of California, Irvine

Last update posted

Mar 18, 2026

Last verified

Mar, 2026

Keywords

Alcohol and Substance Use Prevention
Youth Risk Behaviors
Traumatized Youth
stress management
adolescent

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, Irvine on 2026-03-18.