Ignite Creation Date:
2025-12-24 @ 3:16 PM
Ignite Modification Date:
2026-02-03 @ 8:50 AM
Study NCT ID:
NCT00110292
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
2005-05-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preventing Learning Problems in Young Children: A Public Health and Physician-Based Outreach
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002658', 'term': 'Developmental Disabilities'}, {'id': 'D007805', 'term': 'Language Development Disorders'}], 'ancestors': [{'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D007806', 'term': 'Language Disorders'}, {'id': 'D003147', 'term': 'Communication Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'count': 600}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2002-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-05', 'completionDateStruct': {'date': '2006-02'}, 'lastUpdateSubmitDate': '2005-06-23', 'studyFirstSubmitDate': '2005-05-05', 'studyFirstSubmitQcDate': '2005-05-05', 'lastUpdatePostDateStruct': {'date': '2005-06-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-05-06', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Public health', 'Primary care', 'Parenting education', 'Child rearing', 'Parenting newsletters', 'Child development', 'Language delay'], 'conditions': ['Developmental Disabilities', 'Language Development Disorders']}, 'descriptionModule': {'briefSummary': "This study will evaluate a program to prevent learning problems in children. The program is an inexpensive public health outreach program designed for families living in poverty and is administered through pediatricians' offices and clinics.", 'detailedDescription': "This study will assess the effectiveness of a low-intensity, low-cost, preventive intervention to reduce developmental delay and learning problems in young children. The goal is to improve home caregiving environment factors that are often suboptimal in families living in poverty; these families are often subject to social, economic, and medical risk factors. The intervention is based on a public health/primary care partnership and combines mailed parent-completed Ages \\& Stages Questionnaires (ASQ), a monthly mailed age-paced parenting newsletter (Building Blocks) and corresponding developmental toys (BB), and a Reach Out and Read (ROR) physician-based distribution of children's books.\n\nFamilies of 4- to 7-month-old children attending a participating pediatric clinic will be randomized to either an ASQ/BB+ROR group, an ROR-only group, or a no intervention control group. Outcomes measures will be obtained at 15, 24, 36, and 48 months of age and include measures of the home environment, parenting and parent-child interaction, child language and mental development measures, and rates of referral to Early Intervention programs. Baseline and ongoing demographic information and psychosocial and biological risk factors will also be gathered to see how they relate to child and family outcomes and to determine whether certain subgroups of families are more likely to benefit from the intervention than others."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '7 Months', 'minimumAge': '4 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Attend participating pediatric clinic (serving poor, largely black, and Hispanic communities)\n* Family with child 4 to 7 months of age at enrollment\n* English- or Spanish-speaking\n\nExclusion Criteria\n\n* Developmental delay\n* Eligible for Early Intervention program'}, 'identificationModule': {'nctId': 'NCT00110292', 'briefTitle': 'Preventing Learning Problems in Young Children: A Public Health and Physician-Based Outreach', 'organization': {'class': 'NIH', 'fullName': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)'}, 'officialTitle': 'An RCT of a Low-Intensity Intervention to Reduce Delay', 'orgStudyIdInfo': {'id': 'R01HD040388', 'link': 'https://reporter.nih.gov/quickSearch/R01HD040388', 'type': 'NIH'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Age-specific parenting newsletters and developmental toys', 'type': 'BEHAVIORAL'}, {'name': 'Parent-completed Ages & Stages Questionnaires', 'type': 'BEHAVIORAL'}, {'name': "Clinic-based distribution of children's books", 'type': 'BEHAVIORAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10451', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Montefiore Comprehensive Health Care Center', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '10467', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'North Central Bronx Hospital Pediatric Clinic', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}], 'overallOfficials': [{'name': 'Harris S. Huberman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical & Health Research Association of NYC, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}}}}