Ignite Creation Date:
2025-12-24 @ 5:47 PM
Ignite Modification Date:
2026-02-01 @ 4:22 PM
Study NCT ID:
NCT02279368
Status:
COMPLETED
Last Update Posted:
2014-10-31
First Post:
2014-10-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nursing Led Interdisciplinary Intervention in Prevention of Girl Child Mortality and Maltreatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D005196', 'term': 'Family Therapy'}], 'ancestors': [{'id': 'D011615', 'term': 'Psychotherapy, Group'}, {'id': 'D012960', 'term': 'Socioenvironmental Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 134}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-30', 'studyFirstSubmitDate': '2014-10-28', 'studyFirstSubmitQcDate': '2014-10-30', 'lastUpdatePostDateStruct': {'date': '2014-10-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-10-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Child survival rate (reported incidences of injuries and emergencies)', 'timeFrame': 'Upto six weeks reported incidences of injuries and emergencies'}], 'primaryOutcomes': [{'measure': 'Mother-infant interaction (Parent/Caregiver Involvement Scale)', 'timeFrame': 'Change from Baseline in Parent/Caregiver Involvement Scale at 6 weeks'}], 'secondaryOutcomes': [{'measure': 'Abuse and neglect outcomes (reported incidences of abuse and maltreatment)', 'timeFrame': 'Upto six weeks reported incidences of abuse and maltreatment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Abuse Neglect Social', 'Deprivation, Maltreatment Syndrome (Infant or Child)']}, 'descriptionModule': {'briefSummary': "In Northern India, skewed sex ratios, female feticide and higher child mortality rates for girls have become serious concern. The female child mortality as a result of son preference have increased during the last several decades. Since families cannot know the sex of the fetus due to Indian government policies, they now 'neglect' girl child to ensure there are few survivors. Survival chances of second and third daughters are plunging neglecting healthcare and nutrition has become tool for death as 'good riddance'."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Families having girl child before\n* High risk families with high expectation of having son\n\nExclusion Criteria:\n\n* Families having son before\n* Relocation and moving out of town during study period\n* Not ready to consent for intervention'}, 'identificationModule': {'nctId': 'NCT02279368', 'briefTitle': 'Nursing Led Interdisciplinary Intervention in Prevention of Girl Child Mortality and Maltreatment', 'organization': {'class': 'INDUSTRY', 'fullName': 'Adwin Life Care'}, 'officialTitle': 'Nursing Led Interdisciplinary Intervention in Prevention of Girl Child Mortality and Maltreatment: Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'Adwin006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Group', 'description': 'Nurses delivered the supportive intervention along with family counselling from last term of pregnancy through three months and then were followed till the first birthday of the child.', 'interventionNames': ['Behavioral: Family Counselling and safeguarding']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Control group families were followed in usual care.'}], 'interventions': [{'name': 'Family Counselling and safeguarding', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Intervention Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Mahesāna', 'state': 'Gujarat', 'country': 'India', 'facility': 'Sonal Foundation', 'geoPoint': {'lat': 23.59864, 'lon': 72.38472}}, {'city': 'Satnāli', 'state': 'Haryana', 'country': 'India', 'facility': 'Khatri educational trust', 'geoPoint': {'lat': 28.37627, 'lon': 75.96397}}, {'zip': '302019', 'city': 'Jhunjhunūn', 'state': 'Rajasthan', 'country': 'India', 'facility': 'GyanSanjeevani', 'geoPoint': {'lat': 28.12559, 'lon': 75.39797}}], 'overallOfficials': [{'name': 'Alpesh Barot, MA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sonal Foundation, India'}, {'name': 'Valerie Murray, MA', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Macmillan Research Group'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Adwin Life Care', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Sonal Foundation, India', 'class': 'OTHER'}, {'name': 'Gyaansanjeevani, Jhunjhunu, Rajasthan, India', 'class': 'UNKNOWN'}, {'name': 'Khatri education trust, Satnaali, Hariyana, India', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}