Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2025-12-25 @ 7:54 PM
Study NCT ID:
NCT06197035
Status:
RECRUITING
Last Update Posted:
2024-04-01
First Post:
2023-12-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Coping With and Caring for Infants With Special Needs Intervention in Down Syndrome Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004314', 'term': 'Down Syndrome'}], 'ancestors': [{'id': 'D008607', 'term': 'Intellectual Disability'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D000015', 'term': 'Abnormalities, Multiple'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D025063', 'term': 'Chromosome Disorders'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000097813', 'term': 'Coping Skills'}], 'ancestors': [{'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Two intervention groups, a group with COPCA intervention and a group with standard physiotherapy'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-10-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-28', 'studyFirstSubmitDate': '2023-12-25', 'studyFirstSubmitQcDate': '2023-12-25', 'lastUpdatePostDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Motor Development', 'timeFrame': '3-6-18 months.', 'description': 'INFANT MOTOR PROFILE Results achieved between the 10% and 90% percentiles indicate adequate motor development. Results between the 5% and 10% percentiles indicate a risk for delays or problems in gross motor development.'}], 'secondaryOutcomes': [{'measure': 'Family empowerment', 'timeFrame': '3-6-18 months', 'description': "Family Empowerment Scale\n\nThere are 28 items to be answered by the family with these options:\n\n1= Strongly Agree' 2= Agree' 3= Disagree' 4= Strongly Disagree. The higher the score, the greater the empowerment."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Down Syndrome', 'Family', 'Physical Disability']}, 'descriptionModule': {'briefSummary': "The objective is to compare the impact of standard infant physical therapy and the family-centered program, Coping with and Caring for Infants with Special Needs (COPCA), on infants born with Down syndrome. This is a randomized controlled trial that will be carried out in the patients' homes and outpatient settings in Spain between January 2024 and March 2024. An evaluation battery will be used that includes child and family outcomes and video analysis of therapy sessions.\n\nThe Infant Motor profile will be the primary outcome instrument."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '18 Months', 'minimumAge': '1 Month', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Babies with Down syndrome\n* Families involved in Pediatric Physical Therapy\n\nExclusion Criteria:\n\n* Other associated developmental disorders\n* To not speak Spanish\n* Do not sign informed consent'}, 'identificationModule': {'nctId': 'NCT06197035', 'briefTitle': 'The Coping With and Caring for Infants With Special Needs Intervention in Down Syndrome Infants', 'organization': {'class': 'OTHER', 'fullName': 'University of Seville'}, 'officialTitle': 'Coping and Caring for Families With Babies With Down Syndrome. A Family-centered Intervention', 'orgStudyIdInfo': {'id': 'USeville-EPINTO'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'COPCA (Coping With and Caring for Infants With Special Needs) Intervention', 'description': "The intervention will be delivered by COPCA coaches who follow the programme's theoretical and practical principles. Caregivers learnt how to stimulate their infant's development by challenging their motor behaviour with trial and error experiences.\n\nThis aim to empower the caregivers' competencies to stimulate the infant's daily development, by increasing their motor repertoire.\n\nand enhancing their capacity to adapt movements to situations.", 'interventionNames': ['Procedure: Coping With and Caring for Infants With Special Needs']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard physiotherapy', 'description': 'Standard care will be based on what paediatric physiotherapists generally assume to be useful to promote the development of infants with special needs. Standard care is heterogeneous and eclectic, uses parent training and often includes components of neurodevelopmental treatment with hands-on techniques.', 'interventionNames': ['Procedure: Standard Physiotherapy']}], 'interventions': [{'name': 'Coping With and Caring for Infants With Special Needs', 'type': 'PROCEDURE', 'description': "The early intervention programme for infants and young children focuses on the active inclusion of the whole family. The coaching of parents is a central component. Parents learn how they can independently and optimally support their child's development as part of the child's everyday life. The programme was developed at the beginning of the 2000s in the Netherlands by child physiotherapist Tineke Dirks and professor of developmental neurology Mijna Hadders-Algra.", 'armGroupLabels': ['COPCA (Coping With and Caring for Infants With Special Needs) Intervention']}, {'name': 'Standard Physiotherapy', 'type': 'PROCEDURE', 'description': 'Pediatric physiotherapy techniques aimed at improving the development of the baby and young child from manual therapy tools, or baby management.', 'armGroupLabels': ['Standard physiotherapy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seville', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Piñero Pinto, PhD', 'role': 'CONTACT', 'email': 'epinero@us.es', 'phone': '+34655108763'}], 'facility': 'University of Seville', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}], 'centralContacts': [{'name': 'Elena Pinero-Pinto, PhD', 'role': 'CONTACT', 'email': 'epinero@us.es', 'phone': '+34655108763'}], 'overallOfficials': [{'name': 'Elena Pinero-Pinto, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Seville'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'In 6 months', 'ipdSharing': 'YES', 'description': 'The publication of the results of this research is planned.', 'accessCriteria': 'Asking t the investigator'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Seville', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Elena Piñero Pinto', 'investigatorAffiliation': 'University of Seville'}}}}