[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100622746":3},{"organization":4,"armGroups":7,"interventions":29,"overallOfficials":34,"centralContacts":42,"locations":48,"responsibleParty":67,"collaborators":34,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":73,"sex":79,"minAge":34,"maxAge":80,"enrollmentInfo":81,"targetDuration":34,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":34,"overallStatus":51,"whyStopped":34,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"University of Seville","OTHER",[8,14,20,25],{"label":9,"type":10,"description":11,"interventionNames":12},"In-person COPCA® Intervention","EXPERIMENTAL","COPCA®-based intervention focused on caregiver coaching and promotion of infant motor initiative and variability. One weekly in-person session at the family home, up to 45 minutes, for 6 months.",[13],"Other: Coping with and Caring for Infants with Special Needs",{"label":15,"type":16,"description":17,"interventionNames":18},"Online COPCA® Intervention","ACTIVE_COMPARATOR","COPCA®-based intervention delivered via videoconferencing, focused on caregiver coaching and infant motor initiative and variability. One weekly session of up to 45 minutes for 6 months, following an initial in-person assessment.",[19],"Other: Parental Education Program",{"label":21,"type":16,"description":22,"interventionNames":23},"Parental Education Group","Online group-based parental education on motor development and home stimulation, without individualized child intervention. Sessions of 90 minutes every two weeks for 6 months.",[24],"Other: Conventional Pediatric Physiotherapy",{"label":26,"type":16,"description":27,"interventionNames":28},"Conventional Pediatric Physiotherapy","Standard pediatric physiotherapy delivered according to usual clinical practice in Early Intervention services, with therapist-led sessions using structured exercises and movement facilitation techniques.",[13],[30,35,39],{"type":6,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"Coping with and Caring for Infants with Special Needs","COPCA®-based intervention focused on caregiver coaching and promotion of infant motor initiative and variability. Delivered weekly for up to 45 minutes over 6 months, either in person or online after an initial in-person assessment, integrated into daily routines and emphasizing self-exploration.",[26,9],null,{"type":6,"name":36,"description":37,"armGroupLabels":38,"otherNames":34},"Parental Education Program","Online group-based parental education on motor development and home stimulation, delivered in 90-minute sessions every two weeks for 6 months, without individualized child intervention.",[15],{"type":6,"name":26,"description":40,"armGroupLabels":41,"otherNames":34},"Standard pediatric physiotherapy delivered according to routine clinical practice in Early Intervention services. The intervention consists of therapist-led sessions using structured exercises and movement facilitation techniques, with frequency and duration determined by the reference center.",[21],[43],{"name":44,"role":45,"phone":46,"phoneExt":34,"email":47},"Miryam Quintano-Villar, PT","CONTACT","+34 633665237","mquintano@us.es",[49],{"facility":50,"status":51,"city":52,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Escuela Infantil El Nido de los Perdigones","RECRUITING","Seville","41009","Spain","ES",{"type":57,"coordinates":58},"Point",[59,60],-5.97317,37.38283,{"lat":60,"lon":59},[63],{"name":64,"role":45,"phone":65,"phoneExt":34,"email":66},"Elena Pinero-Pinto","+34 655108763","epinero@us.es",{"type":68,"investigatorFullName":69,"investigatorTitle":70,"investigatorAffiliation":5,"oldNameTitle":34,"oldOrganization":34},"PRINCIPAL_INVESTIGATOR","Elena Piñero Pinto","PT, PhD","100622746","effectiveness-of-the-copca-program-in-infants-at-risk-of-neurodevelopmental-disorders-100622746",false,"NCT07387627","Effectiveness of the COPCA Program in Infants at Risk of Neurodevelopmental Disorders","Effectiveness of the Coping With and Caring for Infants With Special Needs Program in Infants at Risk of Neurodevelopmental Disorders. A Comparison With Conventional Pediatric Physiotherapy Models and Parent Training","COPCA","Inclusion Criteria:\n\n* Infants at risk of neurodevelopmental disorders.\n* Participation in pediatric physiotherapy and\u002For Early Intervention programs at the time of study inclusion, regardless of the reference center.\n* Corrected age under 12 months at the time of recruitment.\n\nExclusion Criteria:\n\n* Infants with confirmed neurodevelopmental disorders at the time of inclusion.\n* Presence of additional medical conditions requiring complex medical or surgical interventions that could interfere with participation in the study (e.g., recent or planned surgery).\n* Severe family socio-communicative difficulties that limit participation in coaching sessions (e.g., significant language barriers).","ALL","12 Months",{"count":82,"type":83},40,"ESTIMATED","INTERVENTIONAL",[86],"NA","The purpose of this clinical trial is to evaluate whether the COPCA® program (Coping with and Caring for Infants with Special Needs) is more effective than conventional pediatric physiotherapy and parent education in improving development in infants at risk of neurodevelopmental disorders, as well as empowering their families.\n\nThis study will include infants younger than 12 months of corrected age who are at risk of neurodevelopmental disorders and are currently receiving early intervention or pediatric physiotherapy services, together with their parents or primary caregivers.\n\nThe main questions this study aims to answer are:\n\nDoes the COPCA® program improve motor development and functional abilities in infants at risk of neurodevelopmental disorders more than conventional pediatric physiotherapy or parent education?\n\nDoes the COPCA® program increase family empowerment and improve parents' perception of the care they receive compared with traditional intervention models?\n\nThe researchers will compare outcomes across four study groups:\n\nIn-person COPCA® intervention\n\nOnline COPCA® intervention\n\nParent education group\n\nConventional pediatric physiotherapy group\n\nParticipants will be randomly assigned to one of the four groups. The intervention period will last 6 months, with assessments conducted at the start of the study, during the intervention, and during follow-up.\n\nInfants will take part in age-appropriate daily activities and play situations. Parents or caregivers will actively participate in the intervention sessions and will be supported in learning how to promote their child's development during everyday routines.\n\nThe study will assess infant motor development, functional abilities, overall development, family empowerment, and parents' perception of family-centered care using validated assessment tools and interviews. The results of this study may help improve early intervention strategies for infants at risk of neurodevelopmental disorders and support more family-centered approaches to care.",[89,90],"Neurodevelopmental Disorders","Neurodevelopmental Disorders and Developmental Abnormalities","2026-04-28",{"date":93,"type":94},"2026-04-29","ACTUAL",{"date":96,"type":94},"2026-02-10",{"date":98,"type":83},"2027-06-01",{"name":5,"class":6},1]