Ignite Creation Date:
2025-12-25 @ 2:58 AM
Ignite Modification Date:
2026-03-02 @ 8:03 PM
Study NCT ID:
NCT01466933
Status:
COMPLETED
Last Update Posted:
2013-07-18
First Post:
2011-11-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Responsive Parenting Program for Infants in Rural Bangladesh
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002657', 'term': 'Child Development'}], 'ancestors': [{'id': 'D006803', 'term': 'Human Development'}, {'id': 'D048788', 'term': 'Growth and Development'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 474}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-07-16', 'studyFirstSubmitDate': '2011-11-04', 'studyFirstSubmitQcDate': '2011-11-04', 'lastUpdatePostDateStruct': {'date': '2013-07-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-11-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bayley scales of infant development', 'timeFrame': '12 months', 'description': 'Cognitive, receptive language and expressive language items will be administered to the child and scored as pass/fail with a total score calculated for each subtest and the total.'}], 'secondaryOutcomes': [{'measure': 'HOME Inventory', 'timeFrame': '12 months', 'description': '45 items assessing through observation and interview opportunities for stimulation in the home.'}, {'measure': 'Mother-Child picture talk', 'timeFrame': '12 months', 'description': "Mothers' responsive talk while looking at pictures with her child."}, {'measure': 'Dietary diversity', 'timeFrame': '12 months', 'description': 'Number out of 7 categories of food, based on Mothers recall foods fed to their child over a 24-hour period.'}, {'measure': 'Child development knowledge of mother', 'timeFrame': '12 months', 'description': 'Mothers report the age when they expect children to start acquiring 10 psychosocial skills, e.g. recognize its mother.'}, {'measure': 'height for age', 'timeFrame': '12 months', 'description': 'height for age z score is derived from the current WHO growth standards'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['parenting intervention', 'child development', 'low and middle income countries'], 'conditions': ['Child Development']}, 'descriptionModule': {'briefSummary': 'Children of mothers in the intervention parenting program are expected to show benefits over the standard care control group in terms of better cognitive/language development, less recent illness, and better height for age. The mothers assigned to the intervention parenting program are expected to evidence higher levels of home stimulation, better health prevention, and better dietary diversity, along with more accurate knowledge of child development.', 'detailedDescription': 'There are actually two intervention groups: in one the program is delivered by trained peer educators from the village, and in the other the program is delivered by trained government personnel.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Months', 'minimumAge': '6 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* mother has a child 6 to 14 months of age\n* mother willing to learn about child care\n\nExclusion Criteria:\n\n* not severely disabled'}, 'identificationModule': {'nctId': 'NCT01466933', 'briefTitle': 'Responsive Parenting Program for Infants in Rural Bangladesh', 'organization': {'class': 'OTHER', 'fullName': 'McGill University'}, 'officialTitle': 'Design, Implementation and Evaluation of a Parent Support/Counselling Program With a Focus on Responsive Stimulation for Infants and Young Children in Rural Bangladesh', 'orgStudyIdInfo': {'id': 'REB#420-0510'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Community-based', 'description': 'Community trained peer educator delivers parenting sessions to mothers in the village on a monthly basis', 'interventionNames': ['Behavioral: Responsive parenting']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Government-based', 'description': 'Government community health workers, trained, deliver the intervention to mothers in the village', 'interventionNames': ['Behavioral: Child Development']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Mothers receive the standard care which is a visit from the health worker'}], 'interventions': [{'name': 'Responsive parenting', 'type': 'BEHAVIORAL', 'description': "On a monthly basis, mothers meet with the peer educator to learn about ways to provide a hygienic environment (hand-washing), proper diverse diet (family foods, breast milk), play materials and conversation to stimulation their child's cognitive and language development. Mothers practice with their child and are coached by the peer educator.", 'armGroupLabels': ['Community-based']}, {'name': 'Child Development', 'type': 'BEHAVIORAL', 'description': "On a monthly basis, mothers meet with the government worker to learn about ways to provide a hygienic environment (hand-washing), proper diverse diet (family foods, breast milk), play materials and conversation to stimulation their child's cognitive and language development.", 'armGroupLabels': ['Government-based']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kushtia', 'country': 'Bangladesh', 'facility': 'Save the Children district office', 'geoPoint': {'lat': 23.9028, 'lon': 89.11943}}], 'overallOfficials': [{'name': 'Frances Aboud, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'McGill University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'McGill University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Save the Children', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Frances Aboud', 'investigatorAffiliation': 'McGill University'}}}}