The THRIVE Study: Teaching Healthy Regulation in Individuals & Vulnerable Environments
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age11-14
SponsorUniversity of California, Irvine
About this trial
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
Qualifiers
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.
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Garnering Resilience in Traumatized youth and families (GRIT)
- Digital Citizenship Curriculum (DCC)
Treatment groups
210 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of California, Irvine
Lead sponsor
University of California, Los Angeles
Collaborator
University of Illinois at Chicago
Collaborator
National Institute on Drug Abuse (NIDA)
Collaborator
Source ClinicalTrials.gov