Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2025-12-31 @ 4:46 PM
Study NCT ID:
NCT01459835
Status:
COMPLETED
Last Update Posted:
2014-03-26
First Post:
2011-10-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Media Impact on Preschool Behavior
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000374', 'term': 'Aggression'}, {'id': 'D000533', 'term': 'Altruism'}, {'id': 'D001519', 'term': 'Behavior'}], 'ancestors': [{'id': 'D000096762', 'term': 'Aberrant Motor Behavior in Dementia'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D012919', 'term': 'Social Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-03-24', 'studyFirstSubmitDate': '2011-10-21', 'studyFirstSubmitQcDate': '2011-10-25', 'lastUpdatePostDateStruct': {'date': '2014-03-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-10-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Social Competence and Behavioral Evaluation (SCBE) scores overall', 'timeFrame': '6 months after enrollment', 'description': 'Overall Social Competence and Behavioral Evaluation (SCBE) scores will be assessed'}, {'measure': 'Social Competence and Behavioral Evaluation (SCBE) aggression subscale', 'timeFrame': '6 months after enrollment', 'description': 'Aggression, from the Social Competence and Behavioral Evaluation (SCBE) subscale scores, will be assessed at 6,'}, {'measure': 'Social Competence and Behavioral Evaluation (SCBE) prosocial subscale', 'timeFrame': '6 months after enrollment', 'description': 'Prosocial, from the Social Competence and Behavioral Evaluation (SCBE) subscale scores, will be assessed'}, {'measure': 'Social Competence and Behavioral Evaluation (SCBE) scores overall', 'timeFrame': '12 months after enrollment', 'description': 'Overall Social Competence and Behavioral Evaluation (SCBE) scores will be assessed'}, {'measure': 'Social Competence and Behavioral Evaluation (SCBE) scores overall', 'timeFrame': '18 months after enrollment', 'description': 'Overall Social Competence and Behavioral Evaluation (SCBE) scores will be assessed'}, {'measure': 'Social Competence and Behavioral Evaluation (SCBE) aggression subscale', 'timeFrame': '12 months after enrollment', 'description': 'Aggression, from the Social Competence and Behavioral Evaluation (SCBE) subscale scores, will be assessed'}, {'measure': 'Social Competence and Behavioral Evaluation (SCBE) aggression subscale', 'timeFrame': '18 months after enrollment', 'description': 'Aggression, from the Social Competence and Behavioral Evaluation (SCBE) subscale scores, will be assessed'}, {'measure': 'Social Competence and Behavioral Evaluation (SCBE) prosocial subscale', 'timeFrame': '12 months after enrollment', 'description': 'Prosocial, from the Social Competence and Behavioral Evaluation (SCBE) subscale scores, will be assessed'}, {'measure': 'Social Competence and Behavioral Evaluation (SCBE) prosocial subscale', 'timeFrame': '18 months after enrollment', 'description': 'Prosocial, from the Social Competence and Behavioral Evaluation (SCBE) subscale scores, will be assessed'}], 'secondaryOutcomes': [{'measure': 'sleep problems', 'timeFrame': '6 months', 'description': 'The investigator will use elements of the sleep problem questionnaire to assess sleep problems'}, {'measure': 'sleep problems', 'timeFrame': '12 months', 'description': 'The investigator will use elements of the sleep problem questionnaire to assess sleep problems'}, {'measure': 'sleep problems', 'timeFrame': '18 months', 'description': 'The investigator will use elements of the sleep problem questionnaire to assess sleep problems'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['TV', 'Violence', 'DVDs', 'Behavior', 'Preschool children'], 'conditions': ['Aggression', 'Prosocial Behavior']}, 'referencesModule': {'references': [{'pmid': '23420911', 'type': 'DERIVED', 'citation': 'Christakis DA, Garrison MM, Herrenkohl T, Haggerty K, Rivara FP, Zhou C, Liekweg K. Modifying media content for preschool children: a randomized controlled trial. Pediatrics. 2013 Mar;131(3):431-8. doi: 10.1542/peds.2012-1493. Epub 2013 Feb 18.'}, {'pmid': '22869826', 'type': 'DERIVED', 'citation': 'Garrison MM, Christakis DA. The impact of a healthy media use intervention on sleep in preschool children. Pediatrics. 2012 Sep;130(3):492-9. doi: 10.1542/peds.2011-3153. Epub 2012 Aug 6.'}]}, 'descriptionModule': {'briefSummary': 'This study tests the hypothesis that modifying the media diet of preschool children so that they watch more prosocial programming and less violent programming will result in decreased aggression and increased prosocial behavior.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '4 Years', 'minimumAge': '2 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 2.5-4 years of age\n* watches TV regularly\n* English speaking\n\nExclusion Criteria:\n\n* no TV\n* non English'}, 'identificationModule': {'nctId': 'NCT01459835', 'briefTitle': 'Media Impact on Preschool Behavior', 'organization': {'class': 'OTHER', 'fullName': "Seattle Children's Hospital"}, 'orgStudyIdInfo': {'id': '5R01HD056506-02', 'link': 'https://reporter.nih.gov/quickSearch/5R01HD056506-02', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'media diet', 'description': 'advice tips and tools to reduce exposure to violent programming', 'interventionNames': ['Behavioral: media diet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Nutrition intervention', 'description': 'diet advice', 'interventionNames': ['Behavioral: nutritional intervention']}], 'interventions': [{'name': 'media diet', 'type': 'BEHAVIORAL', 'description': 'advice and tips and tools for healthy non violent TV viewing', 'armGroupLabels': ['media diet']}, {'name': 'nutritional intervention', 'type': 'BEHAVIORAL', 'description': 'advice on healthy eating', 'armGroupLabels': ['Nutrition intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Seattle CHildrens Research Institute', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Dimitri Christakis, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'U of WA'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Seattle Children's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Dimitri Christakis', 'investigatorAffiliation': "Seattle Children's Hospital"}}}}