Ignite Creation Date:
2025-12-24 @ 1:39 PM
Ignite Modification Date:
2026-01-06 @ 2:42 PM
Study NCT ID:
NCT03040895
Status:
COMPLETED
Last Update Posted:
2023-03-28
First Post:
2017-01-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect Evaluation of The International Child Development Programme (ICDP)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 666}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2021-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-24', 'studyFirstSubmitDate': '2017-01-30', 'studyFirstSubmitQcDate': '2017-01-31', 'lastUpdatePostDateStruct': {'date': '2023-03-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Change in parents' reactions to children's emotions. Measurement: Coping With Toddlers'/Children's Negative Emotions Scale (CTNES/CCNES)", 'timeFrame': 'Assessment points: Baseline (just before the intervention), 10-12 weeks after baseline (immediately after the intervention), and 6 months after baseline'}, {'measure': 'Change in positive Involvement with children. Measurement used: Alabama Parenting Questionnaire (APQ)', 'timeFrame': 'Assessment points: Baseline (just before the intervention), 10-12 weeks after baseline (immediately after the intervention), and 6 months after baseline'}, {'measure': 'Change in Parenting self-efficacy. Measurement: Tool to measure Parenting Self Efficacy (TOPSE)', 'timeFrame': 'Assessment points: Baseline (just before the intervention), 10-12 weeks after baseline (immediately after the intervention), and 6 months after baseline'}], 'secondaryOutcomes': [{'measure': 'Change in inter-parental conflict over child rearing issues. Measurement: Parenting Problem Checklist (PPC)', 'timeFrame': 'Assessment points: Baseline (just before the intervention), 10-12 weeks after baseline (immediately after the intervention), and 6 months after baseline'}, {'measure': 'Change in the parent- child relationship. Measurement: Child-parent relationship scale (CPRS)', 'timeFrame': 'Assessment points: Baseline (just before the intervention), 10-12 weeks after baseline (immediately after the intervention), and 6 months after baseline', 'description': 'Closeness and conflicts'}, {'measure': "Change in the child's psychosocial functioning. Measurement:Strength and Difficulties Questionnaire (SDQ)", 'timeFrame': 'Assessment points: Baseline (just before the intervention), 10-12 weeks after baseline (immediately after the intervention), and 6 months after baseline', 'description': 'Emotional symptoms, hyperactivity, conduct problems, peer problems, prosocial behavior'}, {'measure': "Change in the child's quality of life. Measurement: KINDer und Jugendliche zur Erfassung der gesundheitsbezogenen Lebensqualität (KINDL)", 'timeFrame': 'Assessment points: Baseline (just before the intervention), 10-12 weeks after baseline (immediately after the intervention), and 6 months after baseline'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Parenting practices'], 'conditions': ['Parenting', 'Parent-Child Relations', 'Child Development']}, 'descriptionModule': {'briefSummary': "This study evaluate if a parental guidance programme based on the International Child Development Programme (ICDP) offered to the general Norwegian population, has an effect on caregivers, the relationship between caregiver and child, and on children's Development.", 'detailedDescription': "The International Child Development Programme (ICDP) is a psychosocial preventive programme offered to parents and other caregivers. The programme aims to improve parenting practices and thereby child development and well-being. The ICDP is designed to influence and improve the quality of contact and relation between the caregivers, usually parents, and their children through the practical application of eight themes or guidelines for positive interaction. ICDP courses are implemented in a group format and include group discussions, caregiver assignments, and report back through a sequence of eight meetings. The caregiver groups are led by facilitators trained in the ICDP, and with the competence to lead such groups.\n\nThe aim of this study is to evaluate if ICDP has an effect on caregiver's positive involvement and sensitivity to childrens emotions, and on parental self-efficacy. The study will also evaluate the effect of ICDP on caregiver-child relationships, and the children's development and well-being.\n\nThe study will use a stratified cluster randomized control design, and will be implemented in regular clinical practice in Norway.\n\nMore knowledge within this field is important for practitioners as well as policy makers in planning preventive interventions for caregivers ant their children."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Caregivers with children between the age of 0-18 years, from the general Norwegian population\n* Participants must be able to speak and write adequately Norwegian\n\nExclusion Criteria:\n\n* Not having children between 0-18 years\n* Insufficient Norwegian language skills\n* ICDP imposed by resolution in the Fylkesnemnda'}, 'identificationModule': {'nctId': 'NCT03040895', 'acronym': 'ICDP RCT', 'briefTitle': 'Effect Evaluation of The International Child Development Programme (ICDP)', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Norwegian Institute of Public Health'}, 'officialTitle': 'Effect Evaluation of The International Child Development Programme (ICDP)', 'orgStudyIdInfo': {'id': 'Public 360-nr. 16/13557'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ICDP-intervention for caregivers', 'description': 'Group-based ICDP-intervention for caregivers through a sequence of eight meetings. The groups are led by facilitators trained in the ICDP.', 'interventionNames': ['Other: Group-based ICDP-intervention']}, {'type': 'OTHER', 'label': 'Treatment as usual', 'description': 'Participants may use other health services (GP, other interventions) as usual through the data Collection period (6 months). Afther this period, they will have the opportunity to join an ICDP-Group if they still want.', 'interventionNames': ['Other: Treatment as usual']}], 'interventions': [{'name': 'Group-based ICDP-intervention', 'type': 'OTHER', 'description': 'Group-based ICDP-intervention for caregivers through a sequence of eight meetings', 'armGroupLabels': ['ICDP-intervention for caregivers']}, {'name': 'Treatment as usual', 'type': 'OTHER', 'description': 'Treatment as usual through the data collection period (6 months)', 'armGroupLabels': ['Treatment as usual']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'PO Box 4404, N-0403 Oslo', 'city': 'Oslo', 'country': 'Norway', 'facility': 'Norwegian Institute of Public Health', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'overallOfficials': [{'name': 'Gun-Mette B. Røsand, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Norwegian Institute of Public Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Norwegian Institute of Public Health', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Norwegian Directorate for Children, Youth and Family Affairs', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}