Ignite Creation Date:
2025-12-24 @ 7:30 PM
Ignite Modification Date:
2025-12-29 @ 11:33 AM
Study NCT ID:
NCT01826903
Status:
COMPLETED
Last Update Posted:
2015-04-20
First Post:
2013-03-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Perinatal Depression Treatment and Child Development
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 964}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-17', 'studyFirstSubmitDate': '2013-03-26', 'studyFirstSubmitQcDate': '2013-04-04', 'lastUpdatePostDateStruct': {'date': '2015-04-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-04-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Estimate of general intelligence', 'timeFrame': 'Re-enrollment visit, approximately 7 years post-intervention'}, {'measure': 'Measures of executive functions', 'timeFrame': 'Re-enrollment visit, approximately 7 years post-intervention', 'description': 'Working memory, cognitive flexibility, inhibitory control, and sustained attention will be measured by standard tests of cognitive functioning.'}, {'measure': 'Level of literacy and numeracy', 'timeFrame': 'Re-enrollment visit, approximately 7 years post-intervention'}, {'measure': 'Presence of behavioral and emotional problems (socio-emotional development)', 'timeFrame': 'Re-enrollment visit, approximately 7 years post-intervention'}], 'secondaryOutcomes': [{'measure': 'Height-for-age', 'timeFrame': 'Re-enrollment visit, approximately 7 years post-intervention'}, {'measure': 'Weight-for-age', 'timeFrame': 'Re-enrollment visit, approximately 7 years post-intervention'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Depression', 'Cognitive Behavior Therapy', 'Child Development'], 'conditions': ['Depression']}, 'referencesModule': {'references': [{'pmid': '18790313', 'type': 'BACKGROUND', 'citation': 'Rahman A, Malik A, Sikander S, Roberts C, Creed F. Cognitive behaviour therapy-based intervention by community health workers for mothers with depression and their infants in rural Pakistan: a cluster-randomised controlled trial. Lancet. 2008 Sep 13;372(9642):902-9. doi: 10.1016/S0140-6736(08)61400-2.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine whether the successful perinatal depression intervention among mothers (Thinking Healthy Programme, THP) has led to improved developmental outcomes in the children 6 years later. Economic and human resources aspects of the intervention will also be evaluated to determine overall societal benefits from investment in such a program, feasibility of scaling up the intervention and its sustainability in the long-term. The primary hypothesis is that children of mothers who participated in the THP will have better cognitive outcomes and socio-emotional functioning when compared to children of mothers randomized to the control group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '7 Years', 'minimumAge': '6 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study population includes children of women who participated in the Thinking Healthy Programme and children of women who were eligible for participation in the Thinking Healthy Programme but who screened negative for depression at the time.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* children of women who were eligible to participate in the Thinking Healthy Programme\n\nExclusion Criteria:\n\n* developmental disability, visual or hearing impairment'}, 'identificationModule': {'nctId': 'NCT01826903', 'briefTitle': 'Perinatal Depression Treatment and Child Development', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Perinatal Depression Treatment and Child Development: A Follow-Up of the Thinking Healthy Programme', 'orgStudyIdInfo': {'id': 'Pro00034166'}, 'secondaryIdInfos': [{'id': 'Saving Brains #0058', 'type': 'OTHER_GRANT', 'domain': 'Grand Challenges Canada'}, {'id': 'ISRCTN65316374', 'type': 'REGISTRY', 'domain': 'International Standard Randomised Controlled Trial Number'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'depressed mother/child dyad - intervention'}, {'label': 'depressed mother/child dyad - no intervention'}, {'label': 'non-depressed mother/child dyad'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Islamabad', 'country': 'Pakistan', 'facility': 'Human Development Research Foundation', 'geoPoint': {'lat': 33.72148, 'lon': 73.04329}}], 'overallOfficials': [{'name': 'Joanna Maselko, ScD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}, {'name': 'Siham Sikander, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Human Development Research Foundation, Pakistan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Human Development Research Foundation, Pakistan', 'class': 'OTHER'}, {'name': 'Grand Challenges Canada', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}