[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100638156":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":42,"centralContacts":46,"locations":54,"responsibleParty":71,"collaborators":74,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":86,"sex":87,"minAge":88,"maxAge":10,"enrollmentInfo":89,"targetDuration":10,"studyType":92,"phases":10,"briefSummary":93,"conditions":94,"keywords":99,"overallStatus":57,"whyStopped":10,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"University of Texas Southwestern Medical Center","OTHER",[8,16,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Group A - Parent with Bipolar Disorder",null,"Parents (age 18 or older) who have ever been diagnosed with bipolar disorder and have a biological child between the ages of 7-21",[13,14,15],"Other: Co-design Workshop (Observational Procedure)","Other: Alpha Testing (Observational Procedure)","Other: Beta Testing (Observational Procedure)",{"label":17,"type":10,"description":18,"interventionNames":19},"Group B - Adult Caregiver","Caregivers (age 18 or older) who are primarily responsible for a child between the ages of 7-21 whose biological parent has a lifetime diagnosis of bipolar disorder",[13,14,15],{"label":21,"type":10,"description":22,"interventionNames":23},"Group C - At-Risk Youth","Youth (ages 7-21) without bipolar disorder, but has at least 1 biological parent with a lifetime diagnosis of bipolar disorder",[13,14,15,24],"Other: Youth Screening Pathway & Brief Follow-Up Interview (Observational Procedure)",[26,30,34,38],{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":10},"Co-design Workshop (Observational Procedure)","Participants in the workshop will help to co-design decision aid prototypes (short video and FAQ document) focused on early mental health screening for youth with one or more biological parents impacted by BD.",[9,17,21],{"type":6,"name":31,"description":32,"armGroupLabels":33,"otherNames":10},"Alpha Testing (Observational Procedure)","Participants will provide feedback on the initial version of the patient decision aid (short video and FAQ document).",[9,17,21],{"type":6,"name":35,"description":36,"armGroupLabels":37,"otherNames":10},"Beta Testing (Observational Procedure)","Participants will provide feedback on the refined version of the patient decision aid (short video and FAQ document).",[9,17,21],{"type":6,"name":39,"description":40,"armGroupLabels":41,"otherNames":10},"Youth Screening Pathway & Brief Follow-Up Interview (Observational Procedure)","Youth participants will take screening surveys for early bipolar risk detection.",[21],[43],{"name":44,"affiliation":5,"role":45},"Karabi Nandy, PhD","PRINCIPAL_INVESTIGATOR",[47,52],{"name":48,"role":49,"phone":50,"phoneExt":10,"email":51},"Karabi Nandy, Ph.D.","CONTACT","214-648-4490","FOCUSBipolar@UTSouthwestern.edu",{"name":48,"role":49,"phone":53,"phoneExt":10,"email":51},"214-648-9551",[55],{"facility":56,"status":57,"city":58,"state":59,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"UT Southwestern Medical Center","RECRUITING","Dallas","Texas","75390","United States","US",{"type":64,"coordinates":65},"Point",[66,67],-96.80667,32.78306,{"lat":67,"lon":66},[70],{"name":48,"role":49,"phone":53,"phoneExt":10,"email":51},{"type":45,"investigatorFullName":72,"investigatorTitle":73,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Karabi Nandy","Professor of Biostatistics & Psychiatry",[75],{"name":76,"class":77},"The Texas Child Mental Health Care Consortium (TCMHCC)","UNKNOWN","100638156","focus-bipolar-families-opening-conversations-for-understanding-signs-100638156",false,"NCT07622927","FOCUS Bipolar: Families Opening Conversations for Understanding Signs","A Data-Driven Approach to Early Mental Health Screening in Offspring of Parents With Bipolar Disorder","FOCUS Bipolar","Inclusion Criteria for Group A - Parent with Bipolar Disorder:\n\n1. Age: 18 years or older.\n2. Confirmation of a lifetime Bipolar I or II diagnosis\n3. Parent status: Has at least one biological child aged 7-21 years.\n4. Capacity and willingness to consent: Able and willing to provide informed consent.\n5. Study participation: Able to comply with study procedures (e.g., co-design sessions, interviews, assessments).\n6. Language: Able to read, speak, and understand English.\n\nInclusion Criteria for Group B - Adult Caregiver:\n\n1. Age: 18 years or older.\n2. Caregiver status: The adult primarily responsible for the daily care and\u002For medical decisions for ≥ 6 months for a child aged 7-21 years whose biological parent has a lifetime, clinician-confirmed diagnosis of Bipolar I or II disorder.\n3. Capacity and willingness to consent: Able and willing to provide informed consent.\n4. Study participation: Able to comply with study procedures (e.g., co-design sessions, interviews, assessments).\n5. Language: Able to read, speak, and understand English.\n\nInclusion Criteria for Group C - At-Risk Youth:\n\n1. Age:\n\n   1. Phase 1 (co-design) and Phase 2A (alpha testing): 13-18 years\n   2. Phase 2B (beta testing): 13-18 years\n   3. Phase 3 (screening): 7-21 years\n2. Diagnosis status: Must not have a current diagnosis of Bipolar I or II disorder.\n3. Parental diagnosis: Has at least 1 biological parent with a lifetime, clinician-confirmed Bipolar I or II diagnosis (as defined in Groups A and B).\n4. Consent\u002FAssent:\n\n   1. For youth aged 18-21: Able and willing to provide informed consent (verbal)\n   2. For youth aged 7-21: Parent\u002Fguardian\u002FLAR able and willing to provide informed consent (verbal) and youth able to provide assent (verbal)\n5. Participant ability: Able and willing to participate in study activities (e.g., co-design discussions, questionnaires, or screening assessments.\n6. Language: English sufficient to comprehend study procedures and materials.\n\nCriteria for Exclusion of Participants\n\nA potential participant will NOT be eligible for participation in this study if any of the following criteria are met:\n\n1. Unable to provide informed consent due to cognitive impairment or language barriers\n2. Experiencing acute psychiatric instability at enrollment (e.g., acute psychosis or acute suicidality without stabilization)\n3. Has a medical or psychiatric condition that, in the judgment of the Principal Investigator or study clinician, would place undue risk on the individual or interfere with standard clinical care",true,"ALL","7 Years",{"count":90,"type":91},200,"ESTIMATED","OBSERVATIONAL","Bipolar disorder often runs in families, but early symptoms in youth can go unrecognized for years. This project evaluates a structured, family-centered approach to informed screening for youth ages 7-21 who have a biological parent with bipolar disorder.\n\nThe main questions addressed by this project are:\n\nWhether a co-designed video decision aid improves caregiver understanding of bipolar disorder genetic risk and supports informed decisions about youth screening.\n\nWhether remote mental health screening tools are feasible and acceptable for youth with familial risk for bipolar disorder.\n\nWhether screening results can be used to identify early risk patterns and inform tailored follow-up recommendations.\n\nParticipants may be involved in one or more study activities, including co-design of educational decision-aid content, feedback on decision-aid prototypes, beta testing of the decision aid, and remote youth mental health screening. The study does not assign treatment and does not change existing clinical care or clinic routines.",[95,96,97,98],"Bipolar Disorder (BD)","Bipolar Disorder I or II","Bipolar Disorder Family Members","Screening Tool",[100,101,102,103],"bipolar disorder","bipolar I","bipolar II","bipolar disorder screening","2026-05-27",{"date":106,"type":107},"2026-06-03","ACTUAL",{"date":109,"type":107},"2026-03-11",{"date":111,"type":91},"2027-07-31",{"name":5,"class":6},1]