NCT06821035 · University of California, Irvine
The THRIVE Study: Teaching Healthy Regulation in Individuals & Vulnerable Environments
What this study is about
The goal of this 2-treatment group$1 randomly assigned 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.
View original scientific description
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.
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.
Primary outcome measures
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
The YRBSS is a multiple-choice survey that collects health behavior history, including questions about alcohol and cannabis use. Youth who report any substance use in the last 30 days on the YRBS will complete the Timeline Followback Method Assessment (TFB) for the last 30 days. The TFB is used to assess recent marijuana, cigarette, alcohol and other drug use. The 14-item self-administered TFB asks respondents to retrospectively estimate their daily drug over a designated period of time, from 7 days to 2 years prior to the administration date. The TFB can be used to obtain a variety of quantitative estimates of substance use, including change in substance use. Predictive validity, concordance of the TFB with other measures of drug use and strong convergence among the TFB, urine assays, self-report and collateral parent and sibling reports have been demonstrated among white and minoritized adolescents.
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
The DERS-SF is an 18-item abbreviated version of the original, 36-item DERS questionnaire. It measures emotion regulation ability based on 6 subscales: strategies, non-acceptance, impulse, goals, awareness, and clarity. All subscales on the DERS-SF are highly correlated with the original DERS, with correlations ranging from .91 -.98. Each of the DERS-SF subscales have a Cronbach α\> .70 (ranging from .79 to .91). Total scores range from 18 to 90, with higher total score on the DERS-SF indicating greater difficulties in emotion regulation.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Irvine, California
Collaborators
University of California, Los Angeles, University of Illinois at Chicago, National Institute on Drug Abuse (NIDA)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 18, 2026 · Source of record for eligibility and locations