[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100579187":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":41,"locations":50,"responsibleParty":71,"collaborators":74,"id":81,"slug":82,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":11,"eligibilityCriteria":87,"healthyVolunteers":88,"sex":89,"minAge":90,"maxAge":91,"enrollmentInfo":92,"targetDuration":11,"studyType":95,"phases":96,"briefSummary":98,"conditions":99,"keywords":102,"overallStatus":53,"whyStopped":11,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},{"fullName":5,"class":6},"University of California, Irvine","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"GRIT Intervention","EXPERIMENTAL",null,[13],"Behavioral: Garnering Resilience in Traumatized youth and families (GRIT)",{"label":15,"type":16,"description":11,"interventionNames":17},"Digital Citizenship Curriculumn","ACTIVE_COMPARATOR",[18],"Behavioral: Digital Citizenship Curriculum (DCC)",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"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.",[9],{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":11},"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.",[15],[30,33,37,39],{"name":31,"affiliation":5,"role":32},"Dawn T. Bounds, Ph.D.","PRINCIPAL_INVESTIGATOR",{"name":34,"affiliation":35,"role":36},"Norweeta G. Milburn, Ph.D.","University of California, Los Angeles","STUDY_DIRECTOR",{"name":38,"affiliation":35,"role":36},"Karnik Niranjan, M.D., Ph.D.",{"name":40,"affiliation":5,"role":36},"Shin Sanghyuk, Ph.D.",[42,46],{"name":31,"role":43,"phone":44,"phoneExt":11,"email":45},"CONTACT","949-742-7109","boundsd@hs.uci.edu",{"name":47,"role":43,"phone":48,"phoneExt":11,"email":49},"Jenny Fotang","949-516-1694","jfotang@hs.uci.edu",[51],{"facility":52,"status":53,"city":54,"state":55,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"The Regents of the University of California, Irvine","RECRUITING","Irvine","California","92697-7600","United States","US",{"type":60,"coordinates":61},"Point",[62,63],-117.82311,33.66946,{"lat":63,"lon":62},[66,70],{"name":67,"role":43,"phone":68,"phoneExt":11,"email":69},"Madison Spiva","9498247688","mspiva@uci.edu",{"name":31,"role":32,"phone":11,"phoneExt":11,"email":11},{"type":32,"investigatorFullName":72,"investigatorTitle":73,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"Dawn Therese Bounds","Associate Professor",[75,76,78],{"name":35,"class":6},{"name":77,"class":6},"University of Illinois at Chicago",{"name":79,"class":80},"National Institute on Drug Abuse (NIDA)","NIH","100579187","the-thrive-study-teaching-healthy-regulation-in-individuals--vulnerable-environments-100579187",false,"NCT06821035","The THRIVE Study: Teaching Healthy Regulation in Individuals & Vulnerable Environments","Teaching Youth & Families Self-Regulation Skills to Disrupt the Impact of Adverse Childhood Experiences: Preventing Substance Use in Adversity- Impacted Youth","Inclusion Criteria:\n\n* 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\n* Has access to a smartphone and is willing to download applicable apps (95% of all adolescents have access to a smartphone)\n* Youth who are able to speak and read in English\n* Has a parent\u002Fguardian\u002Fprimary caregiver (18 years or older) who is English- or Spanish-speaking and willing to participate in the intervention.\n\nExclusion Criteria:\n\n* Youth who cannot speak and read in English\n* Youth who report any alcohol or cannabis use within the last 14 days\n* Youth currently enrolled in another family-based intervention (i.e., family therapy)\n* Youth in acute distress who are in immediate need of care (e.g., imminent risk of harm to self or others, active psychosis)\n* 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)\n* Youth whose parent\u002Fguardian\u002Fprimary caregiver declines participation will be referred to other programs in their community.\n* 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.",true,"ALL","11 Years","14 Years",{"count":93,"type":94},210,"ESTIMATED","INTERVENTIONAL",[97],"NA","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:\n\n* Aim 1. Examine the effect of GRIT on preventing the early initiation of regular alcohol and cannabis use over time.\n* 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.\n\nResearchers 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.\n\nParticipants will:\n\n* Be randomized to either receive the GRIT intervention (experimental group) or the Digital Citizenship Curriculum (active control group)\n* Complete 3 in-person visits at baseline, post-intervention, and 12-month post intervention\n* Complete HRV assessments using emWave Pro Plus and survey assessments on REDCap during in-person visits.\n* Participate in six 60-minute sessions conducted over 8 weeks via Zoom with an assigned community-health worker\n* Be invited to complete a booster session at 6-months post-intervention\n* Complete online measures at baseline, post-intervention, 6-month, and 12-month post-intervention",[100,101],"Adverse Childhood Experiences","Family Functioning",[103,104,105,106,107],"Alcohol and Substance Use Prevention","Youth Risk Behaviors","Traumatized Youth","stress management","adolescent","2026-03-16",{"date":110,"type":111},"2026-03-18","ACTUAL",{"date":113,"type":111},"2025-04-17",{"date":115,"type":94},"2028-08-31",{"name":5,"class":6},1]