[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Carelon Research\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":102},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,52,80],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":33,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100633373","a-pragmatic-clinical-trial-of-the-we-beat-well-being-education-program-in-adolescent-congenital-heart-disease-we-beat-chd-study-100633373",false,"NCT07525843","A Pragmatic Clinical Trial of the WE BEAT Well-Being Education Program in Adolescent Congenital Heart Disease: WE BEAT CHD Study","PHN WBC","Inclusion Criteria:\n\n* Age 12-17 years old\n* CHD of moderate or severe complexity (Class II\u002FIII, 2018 AHA\u002FACC ACHD, Table 4)\n* English or Spanish language proficiency\n* Receives cardiology care at a PHN or PHN auxiliary site\n* Parent or guardian and participant willing to comply with protocol and provide written\u002Felectronic informed consent and assent\n\nExclusion Criteria:\n\n* CHD of mild or simple complexity (Class I, 2018 AHA\u002FACC ACHD, Table 4)\n* Prior heart transplant to treat CHD\n* Heart disease that is not classified as structural CHD (e.g., connective tissue disease, genetic cardiomyopathy, or acquired heart disease)\n* Cognitive or developmental conditions that limit program participation and\u002For ability to complete self-reported measures as determined by a primary cardiology clinician\n* Suicidality, homicidality, or psychosis in the past 12 months as per medical chart review, clinician report, or eligibility screening\n* Medically unable to participate (e.g., intubated, unable to respond verbally, active delirium)","ALL","12 Years","17 Years",{"count":20,"type":21},390,"ESTIMATED","INTERVENTIONAL",[24],"NA","The goal of this pragmatic clinical trial is to learn if the WE BEAT program, a 5-week group-based online wellbeing and skill-building program, can help teens with congenital heart disease (CHD) improve their ability to handle stress. The main question it aims to answer is if participants who receive the WE BEAT program become more resilient (the ability to bounce back from from tough times or recover from something difficult) and have better quality of life compared to participants who receive usual care. The study also aims to learn if there are connections between participant-reported psychosocial data (such as resilience, feelings about one's life and one's physical, mental, and social wellbeing) and clinical outcomes.\n\nEligible participants who are 12-17-year-old will be in the study for about 6 months and be randomized to receive either the WE BEAT program or usual care. Following completion of the primary WE BEAT intervention at Week 5, intervention arm participants will be randomized to a single-session booster session (occurring at Week 18) vs no booster session. The booster session will be provided in a similar format to the WE BEAT program. A review of all modules\u002Fskills introduced in the program will be provided.\n\nAll participants will complete 4 sets of online surveys and give 3 hair\u002Fsaliva samples at different timepoints. Some participants may volunteer to give optional blood and urine samples.",[27,28,29,30,31,32],"Patient-Reported Outcome Measures (PROMs)","Pragmatic Trial","Adolescent Congenital Heart Disease","Resiliency-building Intervention","Resilience, Psychological","Telemedicine-Based Education",[34,35,36,37,38],"WE BEAT","Well-Being Education Program","Adolescent CHD","Pragmatic Clinical Trial","Telemedicine","RECRUITING","2026-06-18",{"date":42,"type":43},"2026-06-22","ACTUAL",{"date":45,"type":43},"2026-04-20",{"date":47,"type":21},"2029-06",{"name":49,"class":50},"Carelon Research","OTHER",14,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":16,"minAge":58,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":22,"phases":61,"briefSummary":62,"conditions":63,"keywords":65,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},"100639006","bond-direct-breastfeeding-to-enhance-maternal-and-infant-health-in-congenital-heart-disease-100639006","NCT07582848","BOND: Direct Breastfeeding to Enhance Maternal and Infant Health in Congenital Heart Disease","Both mothers and infants are study participants.\n\nInclusion criteria:\n\n1. Pregnant individual carrying a fetus diagnosed with CHD or biological mother of an infant diagnosed with CHD in the neonatal period.\n2. Fetus or newborn with CHD anticipated to require cardiac surgery or transcatheter intervention in the first 30 days of life.\n3. Admission to the ICU (either CICU or NICU) at participating center in 1st week of life and for whom cardiac surgical or transcatheter intervention is anticipated in the first 30 days of life.\n4. Willing to comply with protocol and provide written informed consent\n\nExclusion Criteria:\n\n1. Mother, fetal, or infant medical condition determined by a treating clinician to be contraindicative to study participation.\n2. Mother with a severe, untreated psychiatric condition, substance use disorder, or other circumstances that, in the opinion of the investigator, would interfere with engagement with study tasks or safe participation in the trial.\n3. Mother with a moderate to severe intellectual disability or is otherwise unable to provide informed consent.\n4. Infant birthweight \\\u003C3rd percentile for gestational age\n5. Infant gestational age \\\u003C 36 weeks\n6. Infant with known genetic disorder likely to impact breastfeeding, such as trisomy 21 or cleft palate\n7. Medical condition or congenital anomaly that precludes safe direct breastfeeding for the infant as determined by investigator","18 Years",{"count":60,"type":21},266,[24],"The primary objective of this study is to enhance the rates of direct breast feeding (DBF) among infants with congenital heart disease (CHD), and to gain insights into the implications of DBF on key metrics of child and parent well-being. A multicenter parallel cluster platform design will be employed. The intervention will be a multifaceted approach to enhance direct breastfeeding. Participating sites will be randomized into either intervention (strategies to enhance direct breastfeeding) or conventional care.",[64],"Congenital Heart Disease (CHD)",[66,67,68,69],"Direct breastfeeding","CHD","Infant neurodevelopment","Maternal Mental Health","NOT_YET_RECRUITING","2026-05-06",{"date":73,"type":43},"2026-05-13",{"date":75,"type":21},"2026-04",{"date":77,"type":21},"2030-06",{"name":49,"class":50},8,{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":4,"eligibilityCriteria":86,"healthyVolunteers":11,"sex":16,"minAge":58,"maxAge":4,"enrollmentInfo":87,"targetDuration":4,"studyType":22,"phases":89,"briefSummary":90,"conditions":91,"keywords":92,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":97,"startDateStruct":98,"completionDateStruct":99,"leadSponsor":100,"locationsCount":101},"100639472","prenatally-initiated-psychological-intervention-for-mothers-of-infants-with-congenital-heart-disease-chd-100639472","NCT07582861","Prenatally-initiated Psychological Intervention for Mothers of Infants With Congenital Heart Disease (CHD)","BOND HeartGPS: A Longitudinal Randomized Controlled Trial Examining the Maternal and Infant Effects of a Prenatally-initiated Psychological Intervention for Mothers of Infants With Congenital Heart Disease (CHD)","Both mothers and infants are study participants.\n\nInclusion Criteria:\n\n1. Pregnant individual carrying a fetus diagnosed with CHD or biological mother of an infant diagnosed with CHD in the neonatal period.\n2. Fetus or newborn with CHD anticipated to require cardiac surgery or transcatheter intervention in the first 30 days of life.\n3. CHD diagnosis received between 16.0 and 30.0 weeks gestation.\n4. Singleton pregnancy.\n5. Pregnant mother is planning to continue the pregnancy and pursue surgical or transcatheter intervention for the infant.\n\n5\\. Pregnant mother is able to participate and complete study assessments in English or Spanish.\n\nExclusion Criteria:\n\n1. Mother, fetal, or infant medical condition determined by a treating clinician to be contraindicative to study participation.\n2. Mother with a severe, untreated psychiatric condition, substance use disorder, or other circumstances that, in the opinion of the investigator, would interfere with engagement with study tasks or safe participation in the trial.\n3. Mother with a moderate to severe intellectual disability or is otherwise unable to provide informed consent.\n4. Postnatal diagnosis of CHD.\n5. Fetus with a comorbid condition with a predictable and major impact on neurodevelopment (e.g., Trisomy 21, DiGeorge syndrome).\n6. Pregnant individual is aged \\\u003C18 years.\n7. Pregnant individual is carrying a surrogate pregnancy.\n8. Consented mother completes \\\u003C70% of survey questions at first (baseline) assessment.",{"count":88,"type":21},210,[24],"This is a two-arm, prospective, longitudinal, randomized controlled trial (RCT) that will compare usual care to usual care plus a prenatally initiated, virtually administered psychological intervention, called HeartGPS.",[64],[93,67,94,95,96],"HeartGPS","intervention","Parent mental health","Neurodevelopment",{"date":73,"type":43},{"date":75,"type":21},{"date":77,"type":21},{"name":49,"class":50},17,""]