[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100557720":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":29,"locations":35,"responsibleParty":56,"collaborators":25,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":25,"eligibilityCriteria":66,"healthyVolunteers":62,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":25,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":79,"overallStatus":37,"whyStopped":25,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"University of Haifa","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Dyadic CAT-based Intervention","EXPERIMENTAL","This arm (n=30) will include dyadic CAT-based intervention only.",[13],"Behavioral: Dyadic CAT-based Intervention",{"label":15,"type":16,"description":17,"interventionNames":18},"Psycho-Educational Parent Counseling","ACTIVE_COMPARATOR","This arm (n=30) will include psycho-educational parent counseling only.",[19],"Behavioral: Psycho-Educational Parent Counseling",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"BEHAVIORAL","The experimental dyadic CAT-based intervention will promote mutual sensorimotor play, pretend play, songs, and games among the mother-child dyads while encouraging flexibility, creativity, and enjoyment. This intervention will involve eight weekly 45-minute sessions in the families' homes and will be conducted by trained creative art therapists. The dyadic CAT-based intervention will follow a manualized protocol presenting the goals, principles, and proposed activities for the intervention sessions. It will provide instructions for maintaining intervention fidelity, while allowing flexibility to tailor the meetings to each dyad's strengths and needs. The dyadic CAT-based intervention meetings will be recorded using video camera.",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"This intervention will involve only mothers and will be conducted by trained parent counselors with experience in working with IDD. This intervention will involve eight weekly 45-minute sessions performed online via Zoom. The psycho-educational parent counseling will follow a protocol presenting the goals, principles, and central issues in parenting a child with IDD to improve the parent-child relationship and address concerns and difficulties related to the child's diagnosis, development, and behavior. It will provide general instructions for maintaining study validity and replication, while allowing flexibility to tailor the intervention to each family's needs.",[15],[30],{"name":31,"role":32,"phone":33,"phoneExt":25,"email":34},"Tal-Chen Rabinowitch, PhD","CONTACT","972-51-2722144","talchenr@gmail.com",[36],{"facility":5,"status":37,"city":38,"state":25,"zip":25,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"RECRUITING","Haifa","Israel","IL",{"type":42,"coordinates":43},"Point",[44,45],34.99928,32.81303,{"lat":45,"lon":44},[48,52],{"name":49,"role":32,"phone":50,"phoneExt":25,"email":51},"Rita Abramov, MA","972-50-2596231","rita.abramov@gmail.com",{"name":53,"role":32,"phone":54,"phoneExt":25,"email":55},"Amitai Stern, MA","972-58-6286235","amitaistern1@gmail.com",{"type":57,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Tal-Chen Rabinowitch","Principal Investigator","100557720","dyadic-creative-arts-therapies-based-intervention-for-children-with-intellectual-and-developmental-disabilities-100557720",false,"NCT06541782","Dyadic Creative Arts Therapies-based Intervention for Children With Intellectual and Developmental Disabilities","Effectiveness of Dyadic Creative Arts Therapies (CAT)-Based Intervention for Improvement of Mother-Child Relationship in Children With Intellectual and Developmental Disabilities: A Mixed Methods RCT","Inclusion Criteria:\n\n* Children between the age of 3-7\n* Children with a prior diagnosis of IDD, or studying in special education nursery schools for children with developmental delays\n* The children's mothers\n\nExclusion Criteria:\n\n* Children with additional primary diagnosis of autism spectrum disorder or cerebral palsy\n* Children with additional diagnosis of severe physical disability or serious movement limitations\n* Children with additional diagnosis of sensory disorders such as blindness or deafness","ALL","3 Years","7 Years",{"count":71,"type":72},60,"ESTIMATED","INTERVENTIONAL",[75],"NA","Background: Interactions between parents and children with intellectual and developmental disabilities (IDD) tend to be directive and didactic lacking in playfulness and enjoyment. Recent research has shown that parents of children with IDD who engage in more playful, creative, and enjoyable interactions tend to foster more positive relationships with their children. Early interventions have been shown to enhance parent-child interactions and promote cognitive and socio-emotional development in children with IDD.\n\nObjectives: This mixed-methods randomized controlled trial (RCT) study aims to develop a manualized dyadic Creative-Art-Therapies (CAT)-based intervention for children with IDD and their mothers and assess and explore its effects on the quality of the mother-child interaction and relationship.\n\nMethods: This mixed-methods RCT will investigate and compare two conditions: experimental dyadic CAT-based intervention for children with IDD and their mothers and control psycho-educational counseling intended for mothers only. The sample will consist of sixty dyads of children with IDD between the ages of 3-7 and their mothers, who will be randomly assigned either to experimental or control condition. The experimental group (n=30) will receive 8 weekly individual dyadic CAT-based intervention meetings at their homes and involve both the child and the mother, and the control group (n=30) will receive 8 weekly individual psycho-educational counseling meetings online via Zoom and involve the mother only.",[78],"Intellectual Disabilities Global Developmental Delay",[80,81,82,83,84,85],"Music and Play Intervention","Dyadic Intervention","Children with Intellectual and Developmental Disabilities","Playfulness","Parental Playfulness","Mother-Child Relationship","2024-08-06",{"date":88,"type":89},"2024-08-07","ACTUAL",{"date":91,"type":89},"2024-02-22",{"date":93,"type":72},"2026-12",{"name":5,"class":6},1]