[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659027":3},{"organization":4,"outcomesModule":7,"designInfo":28,"detailedDescription":35,"studyPopulation":27,"armGroups":36,"interventions":47,"overallOfficials":27,"centralContacts":53,"locations":59,"responsibleParty":76,"collaborators":27,"id":79,"slug":80,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":81,"sex":86,"minAge":87,"maxAge":27,"enrollmentInfo":88,"targetDuration":27,"studyType":91,"phases":92,"briefSummary":94,"conditions":95,"keywords":97,"overallStatus":102,"whyStopped":27,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"Stanford University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":27},[9,13],{"measure":10,"description":11,"timeFrame":12},"Adolescent diabetes-related quality of life","The Type 1 Diabetes and Life (T1DAL) survey is a 23-item scale with a teen version (ages 12-17) and a young adult version (ages 18-25) that capture quality of life related to living with diabetes (for those who turn 18 during the study).","From Baseline (post enrollment) to 12-month post-baseline",{"measure":14,"description":15,"timeFrame":16},"Percent time-in-range (TIR)","TIR is strongly linked to risk of health complications and offers valuable insights beyond hemoglobin A1c, particularly.13 Percent time spent in target range (70-180mg\u002FdL) will be calculated based on continuous glucose monitoring (CGM) data captured in a 14-day window. At least 10 days of data will be required within the 14-day window to be included in analyses.","From baseline (post enrollment) to 12-month post-baseline",[18,21,24],{"measure":19,"description":20,"timeFrame":16},"Hemoglobin A1c","HbA1c results will be gathered based on at-home test kits provided and analyzed by University of Minnesota.",{"measure":22,"description":23,"timeFrame":16},"Adolescent diabetes distress","The Problem Areas in Diabetes questionnaire (PAID) is a 20-item scale of emotional responses related to diabetes distress among adolescents.",{"measure":25,"description":26,"timeFrame":12},"Parent diabetes distress","The Parent Diabetes Distress Scale (P-DDS) is a 20-item measure of diabetes related distress among parents of teens with diabetes.",null,{"allocation":29,"interventionModel":30,"interventionModelDescription":31,"primaryPurpose":32,"observationalModel":27,"timePerspective":27,"maskingInfo":33},"RANDOMIZED","CROSSOVER","Participants will be randomized 1:1 to either the intervention condition (offered the intervention immediately post-baseline) or the waitlisted control condition (offered the intervention after completing the 6-month follow-up).","TREATMENT",{"masking":34,"maskingDescription":27,"whoMasked":27},"NONE","The proposed study is a nationwide randomized controlled trial with 200 adolescents ages 12-17 living with type 1 diabetes for at least six months who are US residents and their parents. Participants will be randomized 1:1 to either the intervention condition (offered the intervention immediately post-baseline) or the waitlisted control condition (offered the intervention after completing the 6-month follow-up). The primary outcome endpoint will be 3-month post-baseline, based on prior findings. This cross-over design will support recruitment and retention and offer all participants the opportunity to receive this empirically supported program, while maintaining an experimental comparison group. The revised intervention includes eight 30-minute weekly sessions to be delivered to each parent-adolescent dyad by a trained interventionist. Didactic and interactive content targets parental monitoring, involvement strategies, collaborative problem-solving, and communication across six sessions with two glycemic sessions that focus on glucose monitoring, data interpretation, and strategies to increase\u002Foptimize technology use. Data will be gathered via adolescent and parent report, continuous glucose monitoring (CGM) and other device data, and at-home HbA1c test kits. We will assess intervention outcomes, differential intervention responses, and key drivers of change.",[37,43],{"label":38,"type":39,"description":40,"interventionNames":41},"Intervention","EXPERIMENTAL","Offered the intervention immediately after Baseline data collection",[42],"Behavioral: Insul-In This Together",{"label":44,"type":6,"description":45,"interventionNames":46},"Waitlisted Control","Offered the intervention after 6-Month Post-Baseline data collection",[42],[48],{"type":49,"name":50,"description":51,"armGroupLabels":52,"otherNames":27},"BEHAVIORAL","Insul-In This Together","The \"Insul-In This Together\" intervention consists of eight weekly 30-minute sessions. Each adolescent-parent dyad (an adolescent with corresponding parent\u002Fcaregiver) meets remotely with an interventionist (not in groups). The structure of adolescents and parents receiving the intervention as a single dyad (not in groups) offers space to discuss sensitive topics and flexibility to accommodate variability in families' schedules. Intervention content targets diabetes-related parental monitoring, involvement, and conflict with a focus on communication and problem-solving skills. Diabetes technology use is addressed related to shared goals, expectations, and communication based on each family's current use.",[38,44],[54],{"name":55,"role":56,"phone":57,"phoneExt":27,"email":58},"Jessie J Wong, PhD","CONTACT","6507361517","wongjj@stanford.edu",[60],{"facility":5,"status":27,"city":61,"state":62,"zip":63,"country":64,"countryCode":65,"cosmosGeoPoint":66,"geoPoint":71,"contacts":72},"Palo Alto","California","94305","United States","US",{"type":67,"coordinates":68},"Point",[69,70],-122.14302,37.44188,{"lat":70,"lon":69},[73,74],{"name":55,"role":56,"phone":57,"phoneExt":27,"email":58},{"name":55,"role":75,"phone":27,"phoneExt":27,"email":27},"PRINCIPAL_INVESTIGATOR",{"type":75,"investigatorFullName":77,"investigatorTitle":78,"investigatorAffiliation":5,"oldNameTitle":27,"oldOrganization":27},"Jessie Wong","Clinical Associate Professor, Pediatrics","100659027","insul-in-this-together-leveraging-family-support-and-diabetes-technology-for-adolescents-living-with-type-1-diabetes-100659027",false,"NCT07856836","Insul-In This Together: Leveraging Family Support and Diabetes Technology for Adolescents Living With Type 1 Diabetes","IITT","Inclusion Criteria:\n\n* For adolescent participants: ages 12-17, diagnosed with type 1 diabetes for at least 6 months, US resident, English proficiency, and resides with the participating parent\u002Fcaregiver.\n* For parent participants: residing with eligible and participating adolescent, US resident, and English proficiency.\n\nExclusion Criteria:\n\n* Severe or pervasive physical or mental health condition that would limit participation in data collection or the intervention (e.g., pervasive developmental delays).","FEMALE","12 Years",{"count":89,"type":90},200,"ESTIMATED","INTERVENTIONAL",[93],"NA","The goal of this clinical trial is to learn if the \"Insul-In This Together\" family program works to improve outcomes for adolescents living with type 1 diabetes. It will also learn about how the program influences diabetes-related factors, including parenting. The main questions it aims to answer are:\n\nDoes this program improve glycemic (blood glucose) outcomes? Does this program improve adolescent quality of life related to diabetes? Researchers will offer the program to all participating families, with one group receiving the program right after enrollment and another group receiving the program 6 months later.\n\nAdolescent and parent participants will:\n\nAttend 8 weekly 30-minute videoconference sessions with an interventionist Complete online surveys, share diabetes device data, and conduct at-home A1c tests 3-5 times over a 12-month period",[96],"Diabetes Type 1",[98,99,100,101],"Type 1 Diabetes","Adolescents","Parents","Diabetes Technology","NOT_YET_RECRUITING","2026-09-28",{"date":105,"type":106},"2026-10-05","ACTUAL",{"date":108,"type":90},"2028-01",{"date":110,"type":90},"2032-06",{"name":5,"class":6},1]