Ignite Creation Date:
2025-12-24 @ 4:51 PM
Ignite Modification Date:
2025-12-25 @ 6:28 PM
Study NCT ID:
NCT06802250
Status:
RECRUITING
Last Update Posted:
2025-02-26
First Post:
2024-12-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
RINEW Randomized Controlled Trial 7-year Follow-up
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'The outcome assessment team is separate from the implementation team, and are not aware of intervention components. Materials provided in the intervention (books, toys) may be visible in the participants homes, but the outcome assessment team was not aware that these are related to the intervention.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 620}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-11-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-24', 'studyFirstSubmitDate': '2024-12-30', 'studyFirstSubmitQcDate': '2025-01-29', 'lastUpdatePostDateStruct': {'date': '2025-02-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': "Knowledge of 7 factors related to children's intelligence", 'timeFrame': '6 years after intervention completion', 'description': 'Record of mention of 7 factors in response to question "What are the things that affect a child\'s intelligence?". Factors are: clean environment, parental involvement, nutrition, learning/education at home, learning/education outside of the home, communication, social stimulation.'}, {'measure': 'Knowledge of ways to avoid harm from lead', 'timeFrame': '6 years after intervention completion', 'description': 'Correct response to question "What ways do you know to avoid harm from lead?"'}, {'measure': 'Child screen time', 'timeFrame': '6 years after intervention completion', 'description': 'Number of hours spent using a digital screen per week (on average, caregiver report)'}, {'measure': 'Parental perceived intelligence', 'timeFrame': '6 years after intervention completion', 'description': "Parental rating of child's intelligence (1-7)"}], 'primaryOutcomes': [{'measure': 'Wechsler Intelligence Scale for Children: 5th Edition (WISC-V)', 'timeFrame': '6 years after intervention completion', 'description': 'The WISC-V assessment measures cognitive development and general intellectual abilities in children 6 years 0 months to 16 years 11 months of age (6:0-16:11). Higher scores represent better outcomes.'}, {'measure': 'Child Socioemotional Development', 'timeFrame': '6 years after intervention completion', 'description': 'Maternal-report questionnaire designed to measure psychological adjustment in children and aims to detect any emotional or behavioural problems.'}, {'measure': 'Self-regulation', 'timeFrame': '6 years after intervention completion', 'description': "Observation of children's self-regulation during the administration of the WISC-V assessment."}, {'measure': 'Academic Achievement', 'timeFrame': '6 years after intervention completion', 'description': "Direct assessments of children's reading and math performance"}], 'secondaryOutcomes': [{'measure': 'Caregiver Mental Health', 'timeFrame': '6 years after intervention completion', 'description': 'Center for Epidemiologic Studies Depression Scale (20 questions). Higher scores represent more depressive symptoms experienced.'}, {'measure': 'Home Environment', 'timeFrame': '6 years after intervention completion', 'description': 'The middle childhood Home Observation for Measurement of the Environment (HOME) includes both caregiver report and observational items to assess the quality and quantity of stimulation and support available to the child at home.'}, {'measure': 'School Grade Level', 'timeFrame': '6 years after intervention completion', 'description': "Parental report of child's current (or previous if no longer in school) grade level."}, {'measure': 'Presence of Improved Latrine', 'timeFrame': '6 years after intervention completion', 'description': 'Observation'}, {'measure': 'Presence of Handwashing Station with Soap and Water', 'timeFrame': '6 years after intervention completion', 'description': 'Observation'}, {'measure': 'Knowledge of lead', 'timeFrame': '6 years after intervention completion', 'description': 'Participant response to question "do you know what lead is?"'}, {'measure': 'Bone Lead Levels', 'timeFrame': '6 years after intervention completion', 'description': 'X-ray fluorescence analysis of micrograms of lead per gram bone material'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Child development', 'Water, Sanitation, and Hygiene', 'Nutrition', 'Intervention'], 'conditions': ['Child Development']}, 'descriptionModule': {'briefSummary': 'This study is designed to evaluate the impact of the RINEW multicomponent early child development intervention on child development and risk factors for poor child development in middle childhood. This study is a follow-up assessment of the children and primary caregivers enrolled in the RINEW cluster randomized controlled trial approximately 6 years following intervention completion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '9 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria: Child's primary caregiver was enrolled in the RINEW cluster randomized trial"}, 'identificationModule': {'nctId': 'NCT06802250', 'briefTitle': 'RINEW Randomized Controlled Trial 7-year Follow-up', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Berkeley'}, 'officialTitle': 'Effects of a Multi-component Early Child Development Intervention in Middle- Childhood: a Follow-up Study of the RINEW Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2024-02-17211'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control arm', 'description': 'No intervention administered'}, {'type': 'EXPERIMENTAL', 'label': 'Group only arm', 'description': 'Participants were encouraged to attend fortnightly courtyard group meetings', 'interventionNames': ['Behavioral: RINEW intervention']}, {'type': 'EXPERIMENTAL', 'label': 'Combined delivery arm', 'description': 'Participants were visited by community health promoters once a month in their home as well as receive encouragement to attend monthly courtyard group meetings in between the monthly home visits.', 'interventionNames': ['Behavioral: RINEW intervention']}], 'interventions': [{'name': 'RINEW intervention', 'type': 'BEHAVIORAL', 'description': 'The intervention included behavioral recommendations and guidance on the topics of Nutrition, WASH, Lead exposure prevention, Mental Health, and child stimulation. The intervention also included the provision of nutritional supplements based on age and nutritional status, low-cost picture books and toys, and soapy water bottles.', 'armGroupLabels': ['Combined delivery arm', 'Group only arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1212', 'city': 'Dhaka', 'status': 'RECRUITING', 'country': 'Bangladesh', 'contacts': [{'name': 'Jesmin Sultana, MBBS', 'role': 'CONTACT', 'email': 'jesmin.sultana@icddrb.org', 'phone': '+88 02 2222 77 001-1', 'phoneExt': '4028'}, {'name': 'Jesmin Sultana, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'International Centre for Diarrhoeal Disease Research, Bangladesh', 'geoPoint': {'lat': 23.7104, 'lon': 90.40744}}], 'centralContacts': [{'name': 'Lia Fernald, PhD', 'role': 'CONTACT', 'email': 'fernald@berkeley.edu', 'phone': '(510) 643-9113'}], 'overallOfficials': [{'name': 'Lia Fernald, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Berkeley'}]}, 'ipdSharingStatementModule': {'infoTypes': ['SAP'], 'timeFrame': 'Within 5 years following the completion of data collection.', 'ipdSharing': 'YES', 'description': 'The de-identified data collected for this study will be available on request within 5 years following the completion of data collection.', 'accessCriteria': 'Completion of a signed data-sharing agreement access agreement; use for research purposes only.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Berkeley', 'class': 'OTHER'}, 'collaborators': [{'name': 'Stanford University', 'class': 'OTHER'}, {'name': 'Purdue University', 'class': 'OTHER'}, {'name': 'International Centre for Diarrhoeal Disease Research, Bangladesh', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}