[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"adverse-childhood-experiences\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:adverse-childhood-experiences":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,10,0,[8,49,82,106,135,161,191,218,239,274],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100469135","building-resilient-families-100469135",false,"NCT05388864","Building Resilient Families","A Multi-Component Intervention to Strengthen Families With Adverse Childhood Experiences (ACEs)","Inclusion Criteria:\n\n* Ages 3-11\n* Seen for a well-child visit at a participating pediatric clinic\n\nExclusion Criteria:\n\n* \\\u003C 3 years or \\>11 years of age\n* Significant congenital medical problems\n* Previous participation in parenting program (last 12 months)\n* Sibling enrollment in current study",true,"ALL","3 Years","11 Years",{"count":21,"type":22},340,"ESTIMATED","INTERVENTIONAL",[25],"NA","Prior research suggests that it is possible to improve health outcomes in children with ACEs through multi-component interventions. The challenge for most communities is that health and education systems are fragmented and fail to accommodate families based upon different levels of need. This study utilizes cross-sectoral partnerships to mobilize three vectors (pediatricians, community health workers and parenting educators) to optimize the delivery of vital information and resources to a diverse population of families with ACEs. All vectors are trained in an evidence-informed curriculum to strengthen families and build youth resilience. The study design is a randomized controlled trial of 340 families of children between the ages of 3 to 11 who are generally healthy and have recently seen a pediatrician for a well-child visit.\n\nTo evaluate the efficacy of this intervention, pediatric patients are invited to participate in repeat evaluations within 2 weeks, 3 months, 6 months, and 12 months after their well-child visit. The study will evaluate the following: 1) the association between Child-ACE scores and biomarkers of toxic stress at baseline in children age 3-11 years old; 2) whether the intervention reduces toxic stress and child health and psychosocial problems at follow-up for children with ACEs compared to usual well-child care for children with ACEs; and 3) the impact of mediating and moderating variables. These results will demonstrate that for families with ACEs the intervention will decrease toxic stress associated with ACEs, improve health outcomes, and reduce health disparities.",[28],"Adverse Childhood Experiences",[30,31,32,33,34,35],"adverse childhood experiences","pediatrics","prevention","preventive health services","quality improvement","childhood abuse and neglect","RECRUITING","2026-06-05",{"date":39,"type":40},"2026-06-09","ACTUAL",{"date":42,"type":40},"2022-05-24",{"date":44,"type":22},"2028-05",{"name":46,"class":47},"Loma Linda University","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":16,"sex":17,"minAge":56,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":23,"phases":59,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":48},"100534228","evaluating-an-adverse-childhood-experience-targeting-advocate-model-of-a-substance-use-prevention-program-100534228","NCT06236100","Evaluating an Adverse Childhood Experience-Targeting Advocate Model of a Substance Use Prevention Program","Evaluating an Adverse Childhood Experience-Targeting Advocate Model of a Substance Use Prevention Program: A Hybrid Type 1 Effectiveness-Implementation Trial","Inclusion Criteria: To be eligible to participate in this study, a family must meet all of the following criteria:\n\n* Either reside in, or attend SFP meetings, within one of the 36 New Jersey communities with disproportionate levels of ACEs and substance use disorder (SUD) issues that are assigned to either the treatment or control conditions via the study's cluster randomized controlled trial design\n* Meet family eligibility requirements:\n\n  * One or more adult caregivers\n  * One or more adolescents, ages 7 to 17\n* Caregiver provision of signed and dated informed consent form\n* For children, informed assent and parental permission via the informed consent to participate in the study\n* Stated willingness to comply with all study procedures and lifestyle considerations and availability for the duration of the study\n* Willingness to adhere to the regimens of the SFP and FA interventions\n* Access to necessary resources for participating in a technology-based intervention (i.e., computer, smart phone, internet access)\n\nExclusion Criteria: A family who meets any of the following criteria will be excluded from participation in this study:\n\n* Caregiver has previously completed SFP with one or more children, ages 7 to 17\n* Intellectual disabilities (i.e., cognitive impairments that would prohibit the completion of the SFP curriculum or data collection instruments)\n* Language difficulties (caregivers and children must read and understand spoken English)","7 Years",{"count":58,"type":22},360,[25],"Primary Objective: Conduct a rigorous evaluation of a prevention-based intervention designed to mitigate the harms of adverse childhood experiences (ACEs) exposure and prevent future ACEs, substance use, and overdose within 36 communities experiencing a disproportionate burden of substance use and ACEs.\n\nThe study has three aims: (1) use a cluster randomized controlled trial to test effectiveness of the Strengthening Families Program (SFP) + Family Advocate (FA) intervention on substance use, overdose, and ACEs in 18 communities compared with SFP-only in 18 communities; (2) conduct a robust process evaluation informed by the Consolidated Framework for Implementation Research (CFIR) to explore implementation barriers and facilitators; and (3) conduct a cost evaluation to accurately estimate the costs required to implement SFP and SFP+FA and assess the cost-effectiveness of SFP+FA relative to SFP alone. Findings will provide a roadmap about the best ways to help disproportionately affected communities prevent substance use, overdose, and ACEs.",[62,28],"Substance-Related Disorders",[28,64,65,66,67,68,69,70,71,72],"Strengthening Families Program","Family Advocate","Community-level interventions","Hybrid Type 1 Design","Mixed-Method Evaluation","Effectiveness Trial","Cluster Randomized Controlled Trial","Process Evaluation","Cost Evaluation","2026-04-29",{"date":75,"type":40},"2026-05-05",{"date":77,"type":40},"2023-11-29",{"date":79,"type":22},"2027-09-29",{"name":81,"class":47},"RTI International",{"id":83,"slug":84,"hasResults":11,"nctId":85,"briefTitle":86,"officialTitle":86,"acronym":4,"eligibilityCriteria":87,"healthyVolunteers":16,"sex":17,"minAge":88,"maxAge":89,"enrollmentInfo":90,"targetDuration":4,"studyType":23,"phases":92,"briefSummary":94,"conditions":95,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":48},"100490387","early-phase-1-neurobehavioral-mechanisms-linking-childhood-adversity-to-increased-risk-for-smoking-100490387","NCT05665465","Neurobehavioral Mechanisms Linking Childhood Adversity to Increased Risk for Smoking","Inclusion Criteria:\n\n1. generally healthy\n2. 18-21 years of age\n3. never smoked a full cigarette or used an equivalent amount of other nicotine or tobacco products\n4. no tobacco exposure in the past 3 years\n5. expired air CO level ≤ 3 ppm\n6. corroboration of non-smoking status from 2 collateral reporters\n7. breath alcohol value = 0.000\n\nExclusion Criteria:\n\n1. use of illegal drugs as measured by urine drug screen\n2. reported history of illicit drug use \\> 10 times lifetime\n3. lifetime history of alcohol use disorder\n4. binge drinking \\> 5 times per month over the past 3 months\n5. history of serious mental illness including bipolar or psychotic disorders\n6. significant medical or unstable psychiatric disorders\n7. systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg\n8. heart rate ≥ 100 bpm\n9. use of psychoactive medications (e.g., antidepressants, opioid analgesics, etc.) in the past 6 months\n10. presence of conditions that would make fMRI unsafe (e.g., pacemaker)\n11. brain abnormality (including but not limited to stroke, brain tumor, and seizure disorder)\n12. history of serious traumatic brain injury\n13. claustrophobia\n14. lack of firm resolve to refrain from cigarette, e-cigarette or other tobacco use in the coming year\n15. pregnant, trying to become pregnant, or breastfeeding\n16. inability to understand written and\u002For spoken English language\n17. inability to attend all experimental sessions","18 Years","21 Years",{"count":91,"type":22},150,[93],"EARLY_PHASE1","The purpose of this study is to evaluate how certain childhood experiences influences brain function and responses to nicotine exposure in a group of nonsmoking young adults. The investigators assess responses to nicotine exposure by giving participants a small amount of nicotine or placebo, and then asking them to answer questionnaires. The investigational drugs used in this study are a nicotine nasal spray (i.e., Nicotrol) and\u002For a nasal spray placebo (made of common kitchen ingredients, including a very tiny amount of pepper extract also called capsaicin). The investigators assess brain function through function magnetic resonance imaging (fMRI), which is a noninvasive procedure that uses a magnetic field to take pictures of your brain while you are performing certain tasks. This study will help us to learn more about why some childhood experiences (adverse childhood experiences, or ACEs) contribute to increased risk for smoking and other substance use.",[28,96],"Nicotine Dependence, Cigarettes","2026-04-01",{"date":99,"type":40},"2026-04-02",{"date":101,"type":40},"2024-01-19",{"date":103,"type":22},"2027-05-31",{"name":105,"class":47},"Duke University",{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":4,"eligibilityCriteria":112,"healthyVolunteers":16,"sex":17,"minAge":19,"maxAge":113,"enrollmentInfo":114,"targetDuration":4,"studyType":23,"phases":116,"briefSummary":117,"conditions":118,"keywords":120,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":48},"100579187","the-thrive-study-teaching-healthy-regulation-in-individuals--vulnerable-environments-100579187","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.","14 Years",{"count":115,"type":22},210,[25],"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",[28,119],"Family Functioning",[121,122,123,124,125],"Alcohol and Substance Use Prevention","Youth Risk Behaviors","Traumatized Youth","stress management","adolescent","2026-03-16",{"date":128,"type":40},"2026-03-18",{"date":130,"type":40},"2025-04-17",{"date":132,"type":22},"2028-08-31",{"name":134,"class":47},"University of California, Irvine",{"id":136,"slug":137,"hasResults":11,"nctId":138,"briefTitle":139,"officialTitle":139,"acronym":4,"eligibilityCriteria":140,"healthyVolunteers":11,"sex":141,"minAge":88,"maxAge":142,"enrollmentInfo":143,"targetDuration":4,"studyType":23,"phases":145,"briefSummary":146,"conditions":147,"keywords":150,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":48},"100468253","early-life-exposures-among-children-with-sickle-cell-disease-100468253","NCT05377372","Early Life Exposures Among Children With Sickle Cell Disease","Inclusion Criteria:\n\n* mother of infant with sickle cell disease\n* resides within the city of Birmingham, Alabama or in close proximity\n\nExclusion Criteria:\n\n* prescribed teratogenic medications\n* no\u002Flimited internet access","FEMALE","50 Years",{"count":144,"type":22},20,[25],"This study is being conducted to determine the relationship between early childhood exposures, such as Adverse Childhood Experiences, Social Determinants of Health and nutrition\u002Fbreastfeeding, among children with sickle cell disease, and behavioral interventions aimed to reshape psychological resilience and lifestyle factors towards positive health outcomes.",[148,28,149],"Sickle Cell Disease","Breastfeeding",[151,28,149],"Sickle cell disease","2026-02-05",{"date":154,"type":40},"2026-02-09",{"date":156,"type":40},"2026-02-01",{"date":158,"type":22},"2027-12-31",{"name":160,"class":47},"University of Alabama at Birmingham",{"id":162,"slug":163,"hasResults":11,"nctId":164,"briefTitle":165,"officialTitle":166,"acronym":4,"eligibilityCriteria":167,"healthyVolunteers":16,"sex":17,"minAge":88,"maxAge":168,"enrollmentInfo":169,"targetDuration":4,"studyType":23,"phases":171,"briefSummary":172,"conditions":173,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":182,"lastUpdatePostDateStruct":183,"startDateStruct":185,"completionDateStruct":187,"leadSponsor":189,"locationsCount":48},"100550996","the-iowa-aces-and-sleep-cohort-and-manipulating-sleep-in-young-adults-with-aces-studies-100550996","NCT06454344","The Iowa ACEs and Sleep Cohort and Manipulating Sleep in Young Adults With ACEs Studies","Associations of Adverse Childhood Experiences, Sleep Disruption, and Vascular Dysfunction in Young Adults: The Iowa ACEs and Sleep Cohort and Manipulating Sleep in Young Adults With ACEs Studies","AIM 1\n\nInclusion Criteria:\n\n1. 18-29 years of age\n2. SBP \\\u003C129 and DBP \\\u003C90 mmHg\n3. Body Mass Index \\> 18.5 kg\u002Fm2 and \\\u003C35 kg\u002Fm2\n4. Willing to complete in-home sleep studies\n\nExclusion Criteria:\n\n1. Currently undergoing treatment for a sleep disorder or diagnosed with restless leg syndrome, hypersomnia, parasomnia or narcolepsy, or obstructive sleep apnea\n2. Currently performing overnight shift work\n3. Lifetime history of any psychiatric disorder with psychotic features or bipolar disorder, currently undergoing treatment for substance-induced mood disorder\n4. Endorsed suicidal ideation as indicated by a Moderate or High risk determination on the Columbia Suicide Risk Protocol\n5. Diagnosed neurological disorder or illness affecting the central nervous system\n6. Diagnosed acute or chronic autoimmune disease or chronic inflammatory condition\n7. Current or previous cancer diagnosis\n8. History of moderate or severe traumatic brain injury\n9. Current or previous history of CBT-I treatment or sleep restriction or cognitive restructuring therapy for sleep\n10. History of cardiometabolic disease (e.g., ischemic heart disease, coronary artery disease, stroke, chronic kidney disease, diabetes mellitus), pulmonary disease, or renal disease\n11. Current or recent (within past month) use of anti-hypertensive (including clonidine), lipid lowering, glucose- controlling, or prescription anti-inflammatory medications\n12. Current or recent (within past month) opiates, benzodiazepine or benzodiazepine receptor agonists, or trazodone\n13. Recent changes to or unstable treatment (changes within last 6 mo.) with prescription medications\n14. Currently smoking or using nicotine\n15. Current use of hormone therapy\n16. Current heavy alcohol use, as defined as binge drinking on 5 or more days in the last month, or consuming more than 7 (women) or 14 (men) drinks per week in the last month (per NIAAA definition)\n17. Current or recent (within the last 6 mo.) illicit drug use disorder as indicated by a score of 3 or greater on the Drug Abuse Screening Test (DAST-10)\n18. Current or recent (within 6 mo.) pregnancy OR current or recent breastfeeding (within 3 mo.) OR children under the age of 2 years old in the home\n19. Currently completing greater than 300 minutes of moderate intensity, or greater than 150 minutes of vigorous intensity physical activity, or an equal combination per week\n20. Unstable housing\n\nAIM 2\n\nInclusion Criteria:\n\n1. 18-29 years of age\n2. SBP \\\u003C129 and DBP \\\u003C90 mmHg\n3. Body Mass Index \\> 18.5 kg\u002Fm2 and \\\u003C35 kg\u002Fm2\n4. Willing to complete in-home sleep studies\n5. \\>= 3 Adverse Childhood Experiences\n6. PSQI Global Score \\>5\n7. Sleep Efficiency Score \\\u003C90%\n\nExclusion Criteria:\n\n1. Currently undergoing treatment for a sleep disorder or diagnosed with restless leg syndrome, hypersomnia, parasomnia or narcolepsy, or obstructive sleep apnea\n2. Currently performing overnight shift work\n3. Lifetime history of any psychiatric disorder with psychotic features or bipolar disorder, currently undergoing treatment for substance-induced mood disorder\n4. Endorsed suicidal ideation as indicated by a Moderate or High risk determination on the Columbia Suicide Risk Protocol\n5. Diagnosed neurological disorder or illness affecting the central nervous system\n6. Diagnosed acute or chronic autoimmune disease or chronic inflammatory condition\n7. Current or previous cancer diagnosis\n8. History of moderate or severe traumatic brain injury\n9. Current or previous history of CBT-I treatment or sleep restriction or cognitive restructuring therapy for sleep\n10. History of cardiometabolic disease (e.g., ischemic heart disease, coronary artery disease, stroke, chronic kidney disease, diabetes mellitus), pulmonary disease, or renal disease\n11. Current or recent (within past month) use of anti-hypertensive (including clonidine), lipid lowering, glucose- controlling, or prescription anti-inflammatory medications\n12. Current or recent (within past month) opiates, benzodiazepine or benzodiazepine receptor agonists, or trazodone\n13. Recent changes to or unstable treatment (changes within last 6 mo.) with prescription medications\n14. Currently smoking or using nicotine\n15. Current use of hormone therapy\n16. Current heavy alcohol use, as defined as binge drinking on 5 or more days in the last month, or consuming more than 7 (women) or 14 (men) drinks per week in the last month (per NIAAA definition)\n17. Current or recent (within the last 6 mo.) illicit drug use disorder as indicated by a score of 3 or greater on the Drug Abuse Screening Test (DAST-10)\n18. Current or recent (within 6 mo.) pregnancy OR current or recent breastfeeding (within 3 mo.) OR children under the age of 2 years old in the home\n19. Currently completing greater than 300 minutes of moderate intensity, or greater than 150 minutes of vigorous intensity physical activity, or an equal combination per week\n20. Unstable housing\n21. Likely Obstructive Sleep Apnea, as indicated by an apnea-hypopnea index (AHI) \\>= 15 events\u002Fhour or persistent hypoxemia, as indicated by an arterial oxygen saturation \\\u003C= 88% for \\>5 minutes per night.","29 Years",{"count":170,"type":22},70,[25],"The overall purpose of this study is to understand the role of disrupted sleep in the association of exposure to early life adversity (adverse childhood experiences (ACEs)) with vascular endothelial (dys)function.\n\nIn Aim 1 (The Iowa ACEs and Sleep Cohort Study), the investigators will utilize a cross-sectional cohort design with a state-of-the-art translational approach. Participants will be recruited to objectively characterize the degree to which lower sleep quality and quantity contribute to ACEs-related endothelial dysfunction, inflammation, and oxidative stress in young adults using:\n\n1. rigorous at home sleep monitoring using 7-nights of wrist actigraphy and 2 nights of home-based polysomnography to objectively measure sleep quality (sleep efficiency, wakefulness after sleep onset and sleep depth), and total sleep duration,\n2. in vivo assessment of endothelial function via flow-mediated dilation testing, and\n3. in vitro determination of endothelial cell inflammation and oxidative stress from biopsied endothelial cells. This study to achieve this Aim.\n\nIn Aim 2, approximately 70 eligible participants from Aim 1 (The Iowa ACEs and Sleep Cohort Study) will then be randomized to either a 6-week behavioral sleep intervention (cognitive behavioral therapy for insomnia) or a wait-list control to determine the mechanistic contribution of sleep disruption to vascular dysfunction in young adults with moderate-to-high exposure to adverse childhood experiences (ACEs). Following the intervention, participants will again complete:\n\n1. rigorous at home sleep monitoring using 7-nights of wrist actigraphy and 2 nights of home-based polysomnography to objectively measure sleep quality (sleep efficiency, wakefulness after sleep onset and sleep depth), and total sleep duration,\n2. in vivo assessment of endothelial function via flow-mediated dilation testing, and\n3. in vitro determination of endothelial cell inflammation and oxidative stress from biopsied endothelial cells.",[28,174,175,176,177,178,179,180,181],"Vascular Dilatation","Sleep","Sleep Disturbance","Psychosocial Stressor","Psychological Trauma","Endothelial Dysfunction","Inflammation","Oxidative Stress","2025-12-05",{"date":184,"type":40},"2025-12-11",{"date":186,"type":40},"2024-05-01",{"date":188,"type":22},"2028-10-31",{"name":190,"class":47},"Nathaniel Jenkins",{"id":192,"slug":193,"hasResults":11,"nctId":194,"briefTitle":195,"officialTitle":196,"acronym":4,"eligibilityCriteria":197,"healthyVolunteers":16,"sex":17,"minAge":19,"maxAge":198,"enrollmentInfo":199,"targetDuration":4,"studyType":201,"phases":4,"briefSummary":202,"conditions":203,"keywords":207,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":210,"startDateStruct":212,"completionDateStruct":214,"leadSponsor":216,"locationsCount":48},"100527865","school-violence-exposure-as-an-adverse-childhood-experience-100527865","NCT06153316","School Violence Exposure as an Adverse Childhood Experience","School Violence Exposure as an Adverse Childhood Experience: a Nationwide Study of K- 12 School Responses to Violence and Their Impact on Youth Mental Health and Educational Outcomes","School-level Inclusion criteria:\n\nFor a school to be considered for participation, it should meet all the following criteria:\n\n1. The school must consent to participate in the study.\n2. Gun shooting incident\n\n   * For exposure schools: Must have experienced a gun shooting incident between 1\u002F1\u002F2015-12\u002F31\u002F2022 .\n   * For non-exposure schools: there should not have been a gun shooting incident between 1\u002F1\u002F2011-12\u002F31\u002F2022.\n3. Must have the student population of interest that is middle through grade 12, and-\n\n   * For exposure schools: At least one grade that experienced the shooting should still be studying at the school.\n   * For non-exposure schools: must have the same grade levels as the pair-matched case school and none of them should have been exposed to any gun shooting incident at that school.\n4. Must be a public school.\n\n   * All non-public schools (e.g., private, charter, parochial schools) and schools outside of the middle-12 range (e.g. daycares, only elementary, preschools, and universities) are not eligible for the study.\n\nIndividual-level Inclusion Criteria:\n\nPrincipals: Must be the current Principal of the participating school. Teachers: Must be a current teacher at the participating school. Students: Must be a current student at the participating school studying in grades 6-12.","65 Years",{"count":200,"type":22},2500,"OBSERVATIONAL","This study hypothesize that school safety strategies may contribute to poor mental health and distress among various school populations and proposes the following research questions to be answered through this study:\n\n1. Is there a significant difference in the prevalence of mental health outcomes, perceived school safety, and academic engagement between early adolescent and adolescent students (grades 6 - 12) at schools that have experienced a school shooting and those that have not?\n2. Are existing interventions to promote school safety and security associated with poor mental health outcomes among students and school staff?\n3. Does the strength of this association between school safety interventions and mental health outcomes differ among students and teachers in those schools who have experienced a school shooting versus among students and teachers in those schools who never experienced a school shooting? And, among our sample of students, are these associations moderated by their ACE history? Participants will be asked to self-report data on their mental health and wellness, and perceived school safety through a survey.\n\nResearchers will compare the surveys from the participants from exposure schools (those who experienced a gun shooting incident) with surveys from the participants from non-exposure schools (those who have not experienced a gun shooting incident)",[204,28,205,206],"Mental Health Outcomes","Perceived School Safety","Educational Outcomes",[208],"School gun violence, School safety, mental health, ACEs","2025-09-09",{"date":211,"type":40},"2025-09-16",{"date":213,"type":40},"2024-04-26",{"date":215,"type":22},"2025-12",{"name":217,"class":47},"Teachers College, Columbia University",{"id":219,"slug":220,"hasResults":11,"nctId":221,"briefTitle":222,"officialTitle":223,"acronym":4,"eligibilityCriteria":224,"healthyVolunteers":16,"sex":17,"minAge":88,"maxAge":225,"enrollmentInfo":226,"targetDuration":4,"studyType":23,"phases":228,"briefSummary":229,"conditions":230,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":231,"lastUpdatePostDateStruct":232,"startDateStruct":234,"completionDateStruct":236,"leadSponsor":238,"locationsCount":48},"100598581","aces-sirt1-and-premature-vascular-aging-in-humans-100598581","NCT07073352","ACEs, SIRT1, and Premature Vascular Aging in Humans","Adverse Childhood Experiences and Premature Vascular Aging in Humans: The Role of SIRT1","Inclusion Criteria:\n\n* 18 - 30 years\n* ACE score of 0 OR ≥4 (Aim 1); ACE score ≥4 (Aim 2)\n\nExclusion Criteria:\n\n* Resting arterial blood pressure \\>140\u002F90 mmHg\n* BMI ≥30 kg\u002Fm2 and\u002For weight unstable (\\>2.27 kg change) last 6 month\n* Cardiovascular, metabolic, or pulmonary disease\n* Cardiovascular or metabolic prescription drug use\n* Vasoactive antidepressant drug use (SSRIs and clonidine)\n* Currently pregnant or breastfeeding\n* Heavy alcohol consumption (AUDIT screening)\n* Use of illicit drugs\n* Current tobacco use\n* Regular vigorous (\\>6 MET s) aerobic exercise (\\>4 bouts\u002Fweek, \\>30 min\u002Fbout)\n* Dietary supplementation with antioxidants or habitual use of NSAIDs","30 Years",{"count":227,"type":22},30,[25],"Adverse childhood experiences (ACEs) are directly related to cardiovascular morbidity and mortality, and impaired vascular endothelial function (VEF) is an independent predictor of future cardiovascular disease (CVD) risk \\[1, 2\\]. Previous work from our lab (IRB 202010095) and others \\[3\\] demonstrates impaired VEF in young adults with prior exposure to ACEs even in the absence of clinical CVD risk factors. Sirtuin 1 (SIRT1) is a class III histone deacetylase (HDAC) that plays a role in regulating vascular homeostasis and reductions in SIRT1 are associated with age-related endothelial dysfunction \\[4\\]. We have shown that ACEs-related impairments in VEF are accompanied by reductions in SIRT1 \\[5\\]. However, the mechanisms by which ACE exposure promotes VEF remain unknown. The goal of this project is to establish proof of concept that alterations in vascular SIRT1 expression and activity mediate premature vascular aging in individuals with \\>=4 ACEs compared to those with 0 ACEs and that, because NAD+ is an essential substrate for SIRT1, increasing NAD+ bioavailability will restore VEF in those with \\>=4 ACEs.\n\nThus, we will use a robust translational approach coupling in vivo and in vitro measures of endothelial function, inflammation, oxidative stress, and SIRT1 expression and activity in young adults with (n=30-35) versus without (n=30-35) ACE exposure in a cross-sectional study, and during a randomized controlled trial employing a novel 4-week nicotinamide riboside (NR) supplementation approach to increase SIRT1 activity by increasing cellular NAD+ in ACE+ (n=15\u002Fgroup) to accomplish the following specific aims:\n\n1. Determine the mechanisms by which ACE exposure alters the regulation of VEF by SIRT1. We hypothesize that compared to those without ACEs (ACE-), ACE+ will have (H1a) elevated endothelial oxidative stress and inflammation, (H1b) accompanied by reduced endothelial SIRT1 expression and increased p66SHC expression and acetylation of p65 and p53, (H1c) in association with lower VEF.\n2. Determine how targeting SIRT1 by increasing NAD+ bioavailability affects VEF in young adults with ACEs. We hypothesize that systemic NR supplementation will (H2a) augment cellular SIRT1 activity and (H2b) improve VEF in ACE+.\n\n\\[1\\] Felitti, V.J., Anda, R.F., Nordenberg, D., Williamson, D.F., Spitz, A.M., Edwards, V., Koss, M.P., \\& Marks, J.S. (1998). Relationship of childhood abuse and household dysfunction to many of the leading causes of death in adults: The adverse childhood experiences (ace) study. American Journal of Preventive Medicine, 14(4), 245-258. https:\u002F\u002Fdoi.org\u002F10.1016\u002FS0749-3797(98)00017-8. \\[2\\] Jenkins, N.D.M., \\& Robinson, A.T. (2022). How do adverse childhood experiences get under the skin to promote cardiovascular disease? A focus on vascular health. Function (Oxf), 3(4), zqac032. PMC9279110. 10.1093\u002Ffunction\u002Fzqac032. \\[3\\] Rodriguez-Miguelez, P., Looney, J., Blackburn, M., Thomas, J., Pollock, J.S., \\& Harris, R.A. (2022). The link between childhood adversity and cardiovascular disease risk: Role of cerebral and systemic vasculature. Function. 10.1093\u002Ffunction\u002Fzqac029. \\[4\\] Thompson, A. M., Wagner, R., \\& Rzucidlo, E. M. (2014). Age-related loss of SirT1 expression results in dysregulated human vascular smooth muscle cell function. American Journal of Physiology-Heart and Circulatory Physiology, 307(4), H533-H541. \\[5\\] Jenkins, N.D.M., Rogers, E.M., Banks, N.F., Tomko, P.M., Sciarrillo, C.M., Emerson, S.R., Taylor, A., \\& Teague, T.K. (2021). Childhood psychosocial stress is linked with impaired vascular endothelial function, lower sirt1, and oxidative stress in young adulthood. Am J Physiol Heart Circ Physiol, 321(3), H532-H541. PMC8461842. 10.1152\u002Fajpheart.00123.2021",[28,179],"2025-07-09",{"date":233,"type":40},"2025-07-18",{"date":235,"type":40},"2025-03-27",{"date":237,"type":22},"2027-06-30",{"name":190,"class":47},{"id":240,"slug":241,"hasResults":11,"nctId":242,"briefTitle":243,"officialTitle":244,"acronym":4,"eligibilityCriteria":245,"healthyVolunteers":11,"sex":17,"minAge":88,"maxAge":4,"enrollmentInfo":246,"targetDuration":4,"studyType":23,"phases":248,"briefSummary":249,"conditions":250,"keywords":255,"overallStatus":264,"whyStopped":4,"lastUpdateSubmitDate":265,"lastUpdatePostDateStruct":266,"startDateStruct":268,"completionDateStruct":270,"leadSponsor":272,"locationsCount":48},"100595520","effects-of-online-mindfulness-therapy-on-pain-and-stress-in-adults-with-chronic-migraine-and-adverse-childhood-experiences-100595520","NCT07033520","Effects of Online Mindfulness Therapy on Pain and Stress in Adults With Chronic Migraine and Adverse Childhood Experiences","Effects of Online Mindfulness-Based Cognitive Therapy on Pain, Stress-Related Symptoms, and Functionality in Adults With Chronic Migraine and Adverse Childhood Experiences at the International Hospital of Colombia","Inclusion Criteria:\n\n* Male and female patients aged 18 years or older with a diagnosis of chronic migraine according to the International Classification of Headache Disorders (ICHD-3), based on diagnostic criteria updated through 2018.\n* Willingness to participate in online sessions from 6:00 PM to 8:00 PM on the scheduled day of the intervention.\n* Male and female patients with a score of 4 or higher on the Adverse Childhood Experiences Questionnaire.\n* Patients who provide informed consent.\n\nExclusion Criteria:\n\n* Visual, auditory, cognitive, or functional limitations that prevent understanding of therapeutic activities or the ability to perform home tasks.\n* Presence of systemic inflammatory disorders, including rheumatic and autoimmune diseases.\n* Active malignancy.\n* Pregnancy or breastfeeding at the time of the study.\n* Pre-existing neurological conditions (e.g., epilepsy, neuromuscular disorders, metabolic diseases, among others).\n* Central nervous system tumors.\n* Diagnosis of terminal illnesses that prevent follow-up over time.",{"count":247,"type":22},60,[25],"This study aims to evaluate the effectiveness of an online Mindfulness-Based Cognitive Therapy (MBCT) program in reducing pain, stress-related symptoms, and improving functionality in adults with chronic migraine and a history of adverse childhood experiences (ACE). Participants will be randomly assigned to either the MBCT intervention group or a control group. The intervention is delivered entirely online over eight weeks. The study hypothesizes that MBCT will result in significant improvements in pain perception and stress-related symptoms compared to the control condition.",[251,28,252,253,254],"Chronic Migraine","Depression","Anxiety","Headache Disorders",[256,257,258,259,260,261,262,263],"Mindfulness-Based Cognitive Therapy","MBCT","Trauma","Pain","Headache","Online Psychological Intervention","Migraine","Stress-Related Disorders","NOT_YET_RECRUITING","2025-06-23",{"date":267,"type":40},"2025-06-26",{"date":269,"type":22},"2025-07-01",{"date":271,"type":22},"2025-11-20",{"name":273,"class":47},"Fundación Cardiovascular de Colombia",{"id":275,"slug":276,"hasResults":11,"nctId":277,"briefTitle":278,"officialTitle":279,"acronym":4,"eligibilityCriteria":280,"healthyVolunteers":16,"sex":17,"minAge":88,"maxAge":4,"enrollmentInfo":281,"targetDuration":4,"studyType":23,"phases":282,"briefSummary":283,"conditions":284,"keywords":4,"overallStatus":264,"whyStopped":4,"lastUpdateSubmitDate":285,"lastUpdatePostDateStruct":286,"startDateStruct":288,"completionDateStruct":290,"leadSponsor":292,"locationsCount":294},"100552768","the-accept-study-improving-the-process-of-disclosing-adverse-childhood-experiences-in-community-mental-health-100552768","NCT06477380","The ACCEPT Study: Improving the Process of Disclosing Adverse Childhood Experiences in Community Mental Health","The ACCEPT Study. Developing a Complex Intervention to Improve the Process of Disclosing Adverse Childhood Experience (ACEs) for Service Users and Staff: an Experience-based Co-design Study","Inclusion Criteria:\n\nService users\u002Fsurvivors participants\n\n* be age 18 or over\n* have capacity to consent in research\n* self-reported lived experience of ACEs - defined by the ACE-IQ (WHO, 2018)\n* past or current service user of NHS community mental health services in England\n\nClinical staff participants:\n\n* NHS practitioners who currently or previously worked as a front line allied health professional in a community mental health team\n* employed by Sussex Partnership Foundation Trust\n* have capacity to consent to participate in research\n* be aged 18 or over\n\nExclusion Criteria:\n\nService user\u002Fsurvivor participants\n\n\\- People who have never received support from NHS community mental health services\n\nClinicians\n\n* Staff who have never worked in NHS community mental health services\n* Medics",{"count":144,"type":22},[25],"Experiences of abuse, neglect, domestic violence, severe bullying and community violence in childhood are very common among people who use mental health services. These often have serious and long lasting impacts on people's mental health.When a person decides to disclose or talk about these traumatic experiences it can help healing. However, mental health staff often lack confidence and organisational support to ask about childhood traumatic events and struggle to know how to respond to disclosures or how best to offer follow up support.\n\nA research method called experience-based co-design will be used to find different ways of supporting staff to safely have conversations about childhood trauma with service users. Experience-based co-design involves;\n\n1. Exploring experiences of service users' and staff through in-depth interviewing, observations and group discussions;\n2. Creating a short film of service users' experiences which helps staff and service users work together to identify areas for improvement and explore potential solutions;\n3. Staff and service users working together in teams to develop the ideas into actionable changes to service delivery\n\nThe co-designed intervention could include:\n\n* A training package for community mental health team staff\n* A toolkit for clinicians to help them to safely talk about childhood trauma with service users.\n* Changes to the physical environment to make it feel safer\n* A reflective practice group for staff\n\nAnticipated impacts:\n\nFor service users: Improved experience of disclosing ACEs; improved access to trauma treatment; improved therapeutic relationships; improved mental health outcomes.\n\nFor staff: Improved confidence and competence to sensitively explore ACEs; improved compassion; greater job satisfaction",[28],"2024-06-21",{"date":287,"type":40},"2024-06-27",{"date":289,"type":22},"2024-06",{"date":291,"type":22},"2026-08",{"name":293,"class":47},"King's College London",2]