RECRUITING

The THRIVE Study: Teaching Healthy Regulation in Individuals & Vulnerable Environments

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Conditions

Adverse Childhood ExperiencesFamily FunctioningAlcohol and Substance Use PreventionYouth Risk BehaviorsTraumatized Youthstress managementadolescent

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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. * 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

Official Title

Teaching Youth & Families Self-Regulation Skills to Disrupt the Impact of Adverse Childhood Experiences: Preventing Substance Use in Adversity- Impacted Youth

Quick Facts

Study Start:2025-04-01
Study Completion:2028-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06821035

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:11 Years to 14 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * Has access to a smartphone and is willing to download applicable apps (95% of all adolescents have access to a smartphone)
  3. * Youth who are able to speak and read in English
  4. * Has a parent/guardian/primary caregiver (18 years or older) who is English- or Spanish-speaking and willing to participate in the intervention.
  1. * Youth who cannot speak and read in English
  2. * Youth who report any alcohol or cannabis use within the last 14 days
  3. * Youth currently enrolled in another family-based intervention (i.e., family therapy)
  4. * Youth in acute distress who are in immediate need of care (e.g., imminent risk of harm to self or others, active psychosis)
  5. * 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)
  6. * Youth whose parent/guardian/primary caregiver declines participation will be referred to other programs in their community.
  7. * 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.

Contacts and Locations

Study Contact

Dawn T. Bounds, Ph.D.
CONTACT
949-742-7109
boundsd@hs.uci.edu
Jenny Fotang
CONTACT
949-516-1694
jfotang@hs.uci.edu

Principal Investigator

Dawn T. Bounds, Ph.D.
PRINCIPAL_INVESTIGATOR
University of California, Irvine
Norweeta G. Milburn, Ph.D.
STUDY_DIRECTOR
University of California, Los Angeles
Karnik Niranjan, M.D., Ph.D.
STUDY_DIRECTOR
University of California, Los Angeles
Shin Sanghyuk, Ph.D.
STUDY_DIRECTOR
University of California, Irvine

Study Locations (Sites)

The Regents of the University of California, Irvine
Irvine, California, 92697-7600
United States

Collaborators and Investigators

Sponsor: University of California, Irvine

  • Dawn T. Bounds, Ph.D., PRINCIPAL_INVESTIGATOR, University of California, Irvine
  • Norweeta G. Milburn, Ph.D., STUDY_DIRECTOR, University of California, Los Angeles
  • Karnik Niranjan, M.D., Ph.D., STUDY_DIRECTOR, University of California, Los Angeles
  • Shin Sanghyuk, Ph.D., STUDY_DIRECTOR, University of California, Irvine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-01
Study Completion Date2028-08-31

Study Record Updates

Study Start Date2025-04-01
Study Completion Date2028-08-31

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Adverse Childhood Experiences
  • Family Functioning