Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2025-12-31 @ 1:47 AM
Study NCT ID:
NCT06821035
Status:
RECRUITING
Last Update Posted:
2025-07-18
First Post:
2025-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The THRIVE Study: Teaching Healthy Regulation in Individuals & Vulnerable Environments
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 210}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2028-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-15', 'studyFirstSubmitDate': '2025-01-10', 'studyFirstSubmitQcDate': '2025-02-08', 'lastUpdatePostDateStruct': {'date': '2025-07-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Alcohol, Cannabis & Other Substance Use: CDC Youth Risk Behavior Surveillance System (YRBSS)+ Timeline Followback Method Assessment (TFB)', 'timeFrame': 'Baseline, immediately after the intervention, 6 months post-intervention, 12 months post-intervention', 'description': '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.'}, {'measure': 'Emotional Regulation: Difficulties in Emotional Regulation- Short Form (DERS-SF)', 'timeFrame': 'Baseline, immediately after the intervention, 6 months post-intervention, 12 months post-intervention', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Heart Rate Variability Assessment: EmWave Pro', 'timeFrame': 'Baseline, immediately after the intervention, 12 months post-intervention', 'description': "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."}, {'measure': 'Sleep Quality: The Pittsburgh Sleep Quality Index (PSQI)', 'timeFrame': 'Baseline, immediately after the intervention, 6 months post-intervention, 12 months post-intervention', 'description': '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.'}, {'measure': 'Nutrition: CDC Youth Risk Behavior Surveillance System (YRBSS)', 'timeFrame': 'Baseline, immediately after the intervention, 6 months post-intervention, 12 months post-intervention', 'description': '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.'}, {'measure': 'Physical Activity: CDC Youth Risk Behavior Surveillance System (YRBSS)', 'timeFrame': 'Baseline, immediately after the intervention, 6 months post-intervention, 12 months post-intervention', 'description': '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.'}, {'measure': 'Family Functioning: Family Assessment Device (FAD)', 'timeFrame': 'Baseline, immediately after the intervention, 6 months post-intervention, 12 months post-intervention', 'description': 'The FAD is a 60-item survey that assesses family functioning including problem solving, communication, roles, affective responsiveness, affective involvement, and behavior control. Scores range from 1 to 4 for each response. The higher the overall score, the worse the level of family function. It has reliability at .70 for all subscales except roles.'}, {'measure': 'Psychological Flexibility:', 'timeFrame': 'Baseline, immediately after the intervention, 6 months post-intervention, 12 months post-intervention', 'description': 'The Acceptance and Fusion Questionnaire (AFQ\\_Y8): an 8-item questionnaire developed for youth that examines their psychological inflexibility. It has an internal consistency of .83. Possible total scores range from 0 to 32. A higher total score indicates greater tendency to experience cognitive fusion (i.e. lower psychological flexibility).'}, {'measure': 'Psychological Flexibility:', 'timeFrame': 'Baseline, immediately after the intervention, 6 months post-intervention, 12 months post-intervention', 'description': 'The Acceptance and Action Questionnaire (AAQ-II): a 7-item questionnaire developed for adults to measure their psychological inflexibility and experimental avoidance. It has an internal consistency of .84 and test-retest reliability of .79- .81. Possible total scores range from 7 to 49. Higher total scores on the AAQ-II indicate higher psychological inflexibility, experiential avoidance, and more potential psychological distress. Lower total scores mean more psychological flexibility.'}, {'measure': 'Psychological Stress: Perceived Stress Scale (PSS-10)', 'timeFrame': 'Baseline, immediately after the intervention, 6 months post-intervention, 12 months post-intervention', 'description': "The PSS-10 is a 10-item self-measure of psychological stress. It has two subscales: perceived helplessness \\& lack of self-efficacy. It has a Cronbach's alpha \\>.70 and a test-retest reliability of \\>.70. Total scores range from 0 to 40, with higher scores being indicative of higher levels of perceived stress."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Alcohol and Substance Use Prevention', 'Youth Risk Behaviors', 'Traumatized Youth', 'stress management', 'adolescent'], 'conditions': ['Adverse Childhood Experiences', 'Family Functioning']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'The prevalence of adverse childhood experiences, nationally, by state, and by race or ethnicity - Child Trends. ChildTrends. Accessed August 23, 2023.'}, {'pmid': '33115717', 'type': 'BACKGROUND', 'citation': 'Nelson CA, Scott RD, Bhutta ZA, Harris NB, Danese A, Samara M. Adversity in childhood is linked to mental and physical health throughout life. 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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', 'detailedDescription': "Adverse Childhood Experiences (ACEs) constitute a serious public health issue, impacting almost half of adolescents and over 60% of adults in the United States. High ACEs exposure (i.e., four or more ACEs) may result in self-dysregulation (i.e., challenges managing cognitions, emotions, and behaviors) and lead to early initiation of alcohol and substance use (e.g., self-medication hypothesis) and other biopsychosocial responses, such as cardiometabolic risks (e.g., lowered heart rate variability \\[HRV\\], increased weight and blood pressure, and sleep disturbance), and emotional and/or cognitive dysregulation. Health inequities resulting from self-dysregulation are highest among minoritized and impoverished populations, who experience disproportionately higher exposure to ACEs, and early adolescence is a time in which experimentation with alcohol and drugs occurs. Although not all adolescents who experiment with drugs are later diagnosed with a substance use disorder, those who engage early (i.e., before the age of 14) and regularly are at greater risk. Youth with four or more ACEs may experience a unique type of adversity characterized by chronic, unpredictable stress shaping their perception of and responses to stress. However certain strategies, called Shift and Persist, can mitigate these exposures where one shifts their attention from adverse experiences to future-directed behaviors (e.g., healthy habit adoption, stress management), resulting in improved self-regulation and lower cardiometabolic risks. GRIT is a community health worker (CHW)-delivered psychoeducational health coaching intervention that promotes coping with high exposure to ACEs to regulate the stress response using self-regulation techniques and the development of healthy habits recommended by the California Surgeon General (e.g., supportive relationships, quality sleep, physical activity). We propose conducting a 2-arm Randomized Controlled Trial (RCT) (GRIT vs an active control \\[i.e., digital citizenship\\]) with 210 adolescent-caregiver dyads to determine GRIT's impact 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 will: Aim 1. Examine the effect of GRIT on preventing the early initiation of regular alcohol and cannabis use over time. H1: Adolescents enrolled in GRIT will have lower rates of regular alcohol and/or cannabis use at post-intervention, 6-, and 12-month follow-ups compared to adolescents in the active control group. 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. H2: Youth and caregiver self-regulation will mediate youth initiation of regular alcohol and cannabis use. This community-based study seeks to establish efficacy for a brief, accessible secondary prevention program. Once efficacy is established and the mechanism of action is identified, larger confirmatory efficacy studies and effectiveness trials using innovative approaches (i.e. multi-family groups and social media) in additional settings offer the opportunity to scale and decrease the research-to-practice gap for adversity-impacted youth."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '11 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "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/guardian/primary 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/guardian/primary 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."}, 'identificationModule': {'nctId': 'NCT06821035', 'briefTitle': 'The THRIVE Study: Teaching Healthy Regulation in Individuals & Vulnerable Environments', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Irvine'}, 'officialTitle': 'Teaching Youth & Families Self-Regulation Skills to Disrupt the Impact of Adverse Childhood Experiences: Preventing Substance Use in Adversity- Impacted Youth', 'orgStudyIdInfo': {'id': '4821'}, 'secondaryIdInfos': [{'id': '1R01DA060784-01', 'link': 'https://reporter.nih.gov/quickSearch/1R01DA060784-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GRIT Intervention', 'interventionNames': ['Behavioral: Garnering Resilience in Traumatized youth and families (GRIT)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Digital Citizenship Curriculumn', 'interventionNames': ['Behavioral: Digital Citizenship Curriculum (DCC)']}], 'interventions': [{'name': 'Garnering Resilience in Traumatized youth and families (GRIT)', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['GRIT Intervention']}, {'name': 'Digital Citizenship Curriculum (DCC)', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Digital Citizenship Curriculumn']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92697-7600', 'city': 'Irvine', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Madison Spiva', 'role': 'CONTACT', 'email': 'mspiva@uci.edu', 'phone': '9498247688'}, {'name': 'Dawn T. Bounds, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The Regents of the University of California, Irvine', 'geoPoint': {'lat': 33.66946, 'lon': -117.82311}}], 'centralContacts': [{'name': 'Dawn T. Bounds, Ph.D.', 'role': 'CONTACT', 'email': 'boundsd@hs.uci.edu', 'phone': '949-742-7109'}, {'name': 'Jenny Fotang', 'role': 'CONTACT', 'email': 'jfotang@hs.uci.edu', 'phone': '949-516-1694'}], 'overallOfficials': [{'name': 'Dawn T. Bounds, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Irvine'}, {'name': 'Norweeta G. Milburn, Ph.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of California, Los Angeles'}, {'name': 'Karnik Niranjan, M.D., Ph.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of California, Los Angeles'}, {'name': 'Shin Sanghyuk, Ph.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of California, Irvine'}]}, 'ipdSharingStatementModule': {'timeFrame': 'At the time of publication or within 1 year of study completion.', 'ipdSharing': 'YES', 'description': "Data will be preserved using the National Addiction \\& HIV Data Archive Program (NAHDAP) repository within the Inter-university Consortium for Political and Social Research (ICPSR) platform. To protect participant privacy and confidentiality, shared data will be de-identified using participant ID's to designate each unique individual instead of names. Dates will be randomly shifted using REDCap. Data will be accompanied by detailed metadata to help ease of use. A DOI (Digital Object Identifier) will be assigned to our dataset, ensuring easy access and citation in future research.", 'accessCriteria': 'Data access will be restricted to individuals and institutions with clearly developed public health research objectives and mechanisms in place to oversee ethical use of the data. The restricted access process within NAHDAP will be used for this purpose.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Irvine', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of California, Los Angeles', 'class': 'OTHER'}, {'name': 'University of Illinois at Chicago', 'class': 'OTHER'}, {'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Dawn Therese Bounds', 'investigatorAffiliation': 'University of California, Irvine'}}}}