[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100608455":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":35,"locations":26,"responsibleParty":44,"collaborators":47,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":58,"sex":64,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":26,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":76,"overallStatus":83,"whyStopped":26,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":26},{"fullName":5,"class":6},"ISPA - Instituto Universitario de Ciencias Psicologicas, Sociais e da Vida","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"REDCHIP Intervention Group","EXPERIMENTAL","REDCHIP intervention group will receive 10 telehealth group sessions. CBT strategies are utilized to increase parents' awareness of any maladaptive thoughts and behaviors they may have related to FH (e.g., fear associated with in target glucose levels, reducing insulin to maintain higher glucose levels) and help them to adopt more adaptive coping skills. REDCHiP also includes content to improve participant's parenting skills and some T1D education to promote parents' knowledge and skills related to managing their young child's T1D",[13],"Behavioral: REDCHiP",{"label":15,"type":16,"description":17,"interventionNames":18},"Treatment As Usual Control Group","ACTIVE_COMPARATOR","These participants will receive the usual treatment provided during their medical appointments",[19],"Other: Treatment As Usual Control Group",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BEHAVIORAL","REDCHiP","REDCHIP comprises 10 telehealth group sessions for parents of young children with T1D, is grounded in Cognitive Behavioral Therapy (CBT) principles, and is designed to address parents FH, and their avoidant coping behaviors related to FH. Sessions also focus on strengthening parents' coping strategies associated with T1D management and helping them to reduce feelings of diabetes distress.",[9],null,{"type":6,"name":15,"description":28,"armGroupLabels":29,"otherNames":26},"Participants will receive their treatment as usual in medical appointments",[15],[31],{"name":32,"affiliation":33,"role":34},"Vasco V Costa, MD","William James Center for Research (ISPA)","PRINCIPAL_INVESTIGATOR",[36,40],{"name":32,"role":37,"phone":38,"phoneExt":26,"email":39},"CONTACT","+351929374601","vcosta@ispa.pt",{"name":41,"role":37,"phone":42,"phoneExt":26,"email":43},"Vasco Costa","929374601","26054@alunos.ispa.pt",{"type":34,"investigatorFullName":45,"investigatorTitle":46,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Vasco Vicente Costa","Principal Investigator",[48,50,52,54],{"name":49,"class":6},"Hospital de Santa Maria, Portugal",{"name":51,"class":6},"Centro Hospitalar de Lisboa Central",{"name":53,"class":6},"Fundação para a Ciência e a Tecnologia",{"name":55,"class":6},"Nemours Children's Clinic","100608455","adaptation-of-redchip-intervention-for-the-portuguese-context-100608455",false,"NCT07201779","Adaptation of REDCHIP Intervention for the Portuguese Context","Reducing Emotional Distress for Childhood Hypoglycemia in Parents (REDCHiP) -A Feasibility Randomized Controlled Trial in the Portuguese Context","REDCHIP","Inclusion Criteria:\n\n1. Primary caregivers must have a young child aged ≤ 8 years with a confirmed diagnosis of T1D for at least three months;\n2. Young children must be using either an continuous subcutaneous insulin infusion (CSII) or multiple daily insulin injections (MDI) and continuous glucose monitoring (CGM) for daily T1D treatment;\n3. Parents must have internet access and a computer, tablet or smartphone that connects to the internet.\n\nExclusion Criteria:\n\n1. Parents with severe psychiatric diagnosis;\n2. Families of children with another severe chronic condition (e.g., chronic kidney disease and Crohn's disease);\n3. Parents who are not fluent in Portuguese.","ALL","1 Year","8 Years",{"count":68,"type":69},44,"ESTIMATED","INTERVENTIONAL",[72],"NA","The present Feasibility Randomized Controlled Trial (FRCT) aims to assess the acceptability and effectiveness of REDCHiP intervention, targeting parents of young children with T1D, followed in two major Portuguese hospitals. The objective of this trial is to evaluate (1) acceptability and feasibility by evaluating recruitment and retention rates, attendance throughout the sessions, and responses to parent satisfaction; (2) effectiveness by analyzing changes in parents' FH, diabetes distress (DD), emotional regulation (ER), resilient coping skills (RC), and anxiety and depression as well as changes in child glycemic outcomes (HbA1c, GMI, TBR, TIR, TAR) at three time points among participants allocated on intervention versus Treatment As Usual (TAU) group. Finally, (3) the investigators aim to qualitatively evaluate participant´s experiences and feedback regarding the REDHIP intervention through interviews.",[75],"Type 1 Diabetes",[23,77,78,79,80,81,75,82],"Portuguese Context","Protocol","Psychological Interventions","Parents","Young Children","Telehealth","NOT_YET_RECRUITING","2025-09-30",{"date":86,"type":87},"2025-10-01","ACTUAL",{"date":89,"type":69},"2026-04",{"date":91,"type":69},"2026-12",{"name":5,"class":6}]