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
This trial accepts healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Garnering Resilience in Traumatized youth and families (GRIT)
BehavioralDyads 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)
BehavioralDyads 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.
Treatment groups
210 Participants
are divided into 2 treatment groupsGroup A: GRIT InterventionExperimental treatment 1 intervention
Group B: Digital Citizenship CurriculumnActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Alcohol, Cannabis & Other Substance Use: CDC Youth Risk Behavior Surveillance System (YRBSS)+ Timeline Followback Method Assessment (TFB)
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.
Time frame
Baseline, immediately after the intervention, 6 months post-intervention, 12 months post-intervention2
Emotional Regulation: Difficulties in Emotional Regulation- Short Form (DERS-SF)
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.
Time frame
Baseline, immediately after the intervention, 6 months post-intervention, 12 months post-interventionSecondary outcomes
1
Heart Rate Variability Assessment: EmWave Pro
The emWave Pro is a heart rhythm monitoring system that helps to observe an individual's autonomic state. This software provides HRV assessments that can be used in a wide range of applications such as quantifying HRV levels. Using HeartMath's EmWAVE Pro software, every participant will have an HRV assessment conducted that includes a resting HRV assessment (3 minutes), a stress prep (3 minutes), and a 1-minute deep breathing assessment.
Time frame
Baseline, immediately after the intervention, 12 months post-intervention2
Sleep Quality: The Pittsburgh Sleep Quality Index (PSQI)
PSQI is a 19-item questionnaire that assesses seven component scores; subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. The PSQI has an internal reliability of .83 and test-retest reliability of .85 for the global scale. PSQI global scores range from 0 to 21, with higher scores than 5 indicating sleep disturbance.
Time frame
Baseline, immediately after the intervention, 6 months post-intervention, 12 months post-intervention3
Nutrition: CDC Youth Risk Behavior Surveillance System (YRBSS)
The 2025 middle school version of the YRBSS is a national survey that includes 3 diet and weight-related items assessing nutrition that allow for national comparison with other youth.
Time frame
Baseline, immediately after the intervention, 6 months post-intervention, 12 months post-intervention4
Physical Activity: CDC Youth Risk Behavior Surveillance System (YRBSS)
The 2025 middle school version of the YRBSS is a national survey that includes 3 items assessing physical activity that allows national comparison with other youth.
Time frame
Baseline, immediately after the intervention, 6 months post-intervention, 12 months post-interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
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