Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-27 @ 7:27 AM
Study NCT ID:
NCT01573793
Status:
UNKNOWN
Last Update Posted:
2014-03-26
First Post:
2012-03-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Promoting Optimal Parenting (Bright Start)
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': ['PARTICIPANT']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-03-24', 'studyFirstSubmitDate': '2012-03-30', 'studyFirstSubmitQcDate': '2012-04-05', 'lastUpdatePostDateStruct': {'date': '2014-03-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-04-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Language ENvironment Analysis System (LENA)', 'timeFrame': '6/18/30 months - tracking changes throughout study'}, {'measure': 'Adaptive Behavior Assessment System, Second Edition (ABAS-II)', 'timeFrame': 'Month 12/24/36/42 - tracking changes throughout study'}, {'measure': 'Brief Infant Sleep Questionnaire(BISQ)', 'timeFrame': 'Month 12/24 - tracking changes throughout study'}, {'measure': 'Behavior Rating Inventory of Executive Function - Preschool Version (BRIEF-P)', 'timeFrame': 'Month 24/42 - tracking changes throughout study'}, {'measure': 'MacArthur Communicative Development Inventory- Short Form (CDI)', 'timeFrame': 'Month 24/42 - tracking changes throughout study'}, {'measure': "Children's Sleep Habits Questionnaire (CSHQ)", 'timeFrame': 'Month 36/42 - tracking changes throughout study'}, {'measure': 'Devereux Early Childhood Assessment-Clinical Form (DECA-C)', 'timeFrame': 'Month 24/36/42 - tracking changes throughout study'}, {'measure': 'Devereux Early Childhood Assessment- Infant/Toddler (DECA-I/T)', 'timeFrame': 'Month 12'}, {'measure': 'Family Resource Scale (FRS)', 'timeFrame': 'Baseline'}, {'measure': 'MARLOWE-CROWNE', 'timeFrame': 'Baseline'}, {'measure': 'Maternal Emotional Styles Questionnaire (MESQ)', 'timeFrame': 'Month 36'}, {'measure': 'Patient Health Questionnaire 2 (PHQ-2)', 'timeFrame': 'Baseline and Month 12/24/36/42 - tracking changes throughout study'}, {'measure': 'Preschool Language Scale-5 (PLS-5)', 'timeFrame': 'Month 36'}, {'measure': 'Parenting Sense of Competence-Efficacy(PSOC)', 'timeFrame': 'Baseline and Months 12/24/36/42 - tracking changes throughout study'}, {'measure': 'Social competence subscale of the Social Competence and Behavior Evaluation(SCBE)', 'timeFrame': 'Months 36/42 - tracking changes throughout study'}, {'measure': '(Strange Situation Procedure) SSP', 'timeFrame': 'Month 15'}, {'measure': 'Nursing Child Assessment Teaching Scale (NCATS)', 'timeFrame': 'Months 15/36 - tracking changes throughout study'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Cognitive Development', 'Emotional Development']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to determine if providing parenting education materials delivered in different ways during the first 30 months of a child's life will increase child-parent attachment and promote mother-child interaction, if certain types of strategies improve cognitive, language, and emotional development in infants and toddlers, and if our way of delivering these materials is cost-effective."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '23 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* English-speaking\n* 18-23 year-old first-time mother of a healthy newborn\n\nExclusion Criteria:\n\n* Anything other than above'}, 'identificationModule': {'nctId': 'NCT01573793', 'briefTitle': 'Promoting Optimal Parenting (Bright Start)', 'organization': {'class': 'OTHER', 'fullName': "Seattle Children's Hospital"}, 'officialTitle': 'Promoting Optimal Parenting', 'orgStudyIdInfo': {'id': '13852'}, 'secondaryIdInfos': [{'id': '1R01HD068478-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R01HD068478-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Intervention', 'description': 'Will receive parenting educational materials hypothesized to enhance emotional and cognitive development', 'interventionNames': ['Behavioral: Parenting Education']}, {'type': 'SHAM_COMPARATOR', 'label': 'Control', 'description': 'Will receive safety and dental hygiene materials that have no bearing on emotional and cognitive development', 'interventionNames': ['Behavioral: Control Group - Safety Materials']}], 'interventions': [{'name': 'Parenting Education', 'type': 'BEHAVIORAL', 'description': 'Will receive parenting educational materials hypothesized to enhance emotional and cognitive development', 'armGroupLabels': ['Intervention']}, {'name': 'Control Group - Safety Materials', 'type': 'BEHAVIORAL', 'description': 'Will receive safety and dental hygiene materials that have no bearing on emotional and cognitive development', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98121', 'city': 'Seattle', 'state': 'Washington', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Heather D Violette, Ph.D.', 'role': 'CONTACT', 'email': 'heather.violette@seattlechildrens.org', 'phone': '206-884-8259'}, {'name': 'Dimitri A Christakis, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Seattle Children's Research Institute", 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'centralContacts': [{'name': 'Heather D Violette, Ph.D.', 'role': 'CONTACT', 'email': 'heather.violette@seattlechildrens.org', 'phone': '206-884-8259'}], 'overallOfficials': [{'name': 'Dimitri A Christakis, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Seattle Children's Research Institute, University of Washington"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Seattle Children's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Investigator', 'investigatorFullName': 'Dimitri Christakis', 'investigatorAffiliation': "Seattle Children's Hospital"}}}}