NCT06821035 The THRIVE Study: Teaching Healthy Regulation in Individuals & Vulnerable Environments
| NCT ID | NCT06821035 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of California, Irvine |
| Condition | Adverse Childhood Experiences |
| Study Type | INTERVENTIONAL |
| Enrollment | 210 participants |
| Start Date | 2025-04-17 |
| Primary Completion | 2028-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 210 participants in total. It began in 2025-04-17 with a primary completion date of 2028-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Eligibility Criteria
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.
Contact & Investigator
Dawn T. Bounds, Ph.D.
PRINCIPAL INVESTIGATOR
University of California, Irvine
Frequently Asked Questions
Who can join the NCT06821035 clinical trial?
This trial is open to participants of all sexes, aged 11 Years or older, up to 14 Years, studying Adverse Childhood Experiences. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06821035 currently recruiting?
Yes, NCT06821035 is actively recruiting participants. Contact the research team at boundsd@hs.uci.edu for enrollment information.
Where is the NCT06821035 trial being conducted?
This trial is being conducted at Irvine, United States.
Who is sponsoring the NCT06821035 clinical trial?
NCT06821035 is sponsored by University of California, Irvine. The principal investigator is Dawn T. Bounds, Ph.D. at University of California, Irvine. The trial plans to enroll 210 participants.