Ignite Creation Date:
2025-12-24 @ 12:10 PM
Ignite Modification Date:
2026-01-03 @ 8:35 PM
Study NCT ID:
NCT03058861
Status:
COMPLETED
Last Update Posted:
2025-12-04
First Post:
2017-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mitigating ACEs in Pediatric Primary Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 576}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2018-01-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-26', 'studyFirstSubmitDate': '2017-01-26', 'studyFirstSubmitQcDate': '2017-02-16', 'lastUpdatePostDateStruct': {'date': '2025-12-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-01-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline Parenting Survey at 2 months', 'timeFrame': 'Baseline and 2 months', 'description': 'Parenting Survey: 12 item scale that assesses parenting behaviors.'}], 'secondaryOutcomes': [{'measure': 'Change from baseline Attitudes Toward Spanking scale at 2 months', 'timeFrame': 'Baseline and 2 months', 'description': 'Attitudes Toward Spanking scale'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Violence', 'Parenting']}, 'referencesModule': {'references': [{'pmid': '34780005', 'type': 'RESULT', 'citation': 'Sausen KA, Randolph JW, Casciato AN, Dietrich MS, Scholer SJ. The Development, Preliminary Validation, and Clinical Application of the Quick Parenting Assessment. Prev Sci. 2022 Feb;23(2):306-320. doi: 10.1007/s11121-021-01320-w. Epub 2021 Nov 15.'}]}, 'descriptionModule': {'briefSummary': 'The project is designed to assess Adverse Childhood Experiences (ACEs) and test a parenting intervention in pediatric primary care.', 'detailedDescription': "The goal of the project is to affect policy and practice related to Adverse Childhood Experiences (ACEs) screening and intervention in pediatric primary care. First, the investigators will develop and test a new ACEs screening tool that is brief, has a pediatric perspective, builds on parents' strengths, and measures parenting-related ACEs that can be treated. The new ACEs screening tool will measure parenting-related ACEs (e.g. corporal punishment, threatening, humiliation) and family stressors (e.g. divorce, incarceration, mental illness). A research assistant will invite approximately 1000 parents to complete the survey in the Vanderbilt Pediatric Primary Care Clinic. Measures will include child behavior problems that the investigators hypothesize will be associated with elevated parenting scores. The second part of the project will be to recruit English and Spanish-speaking parents for a randomized controlled trial (RCT) to determine if educational interventions can help educate parents about ACEs and decrease parenting-related ACE scores two months post-intervention. In the RCT, the investigators will recruit 300 to 400 parents to participate in the study. Parents in the intervention group will receive 1) a copy of the Play Nicely Healthy Discipline Handbook, 2) information about how to view the Play Nicely multimedia program online and 3) the TN ACEs Handout. Parents in the Control Group will receive routine primary care. Follow up data will be obtained 2 months after enrollment."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Parents of 2-10 year old children presenting for a well visit.\n\nExclusion Criteria:\n\n* Parents do not speak English, Spanish, or Arabic.'}, 'identificationModule': {'nctId': 'NCT03058861', 'briefTitle': 'Mitigating ACEs in Pediatric Primary Care', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt University Medical Center'}, 'officialTitle': 'Mitigating ACEs in Pediatric Primary Care', 'orgStudyIdInfo': {'id': 'IRB#161987'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Discipline education - Play Nicely program', 'description': 'Parents in the intervention group will receive 1) a copy of the Play Nicely Healthy Discipline Handbook (see www.playnicely.org), 2) information about how to view the Play Nicely multimedia program online and 3) the TN ACEs Handout.', 'interventionNames': ['Behavioral: Play Nicely Program']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Routine primary care will be provided.'}], 'interventions': [{'name': 'Play Nicely Program', 'type': 'BEHAVIORAL', 'description': 'Play Nicely multimedia program and handbook that provides education about healthy discipline strategies.', 'armGroupLabels': ['Discipline education - Play Nicely program']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt Pediatric Primary Care Clinic', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Seth Scholer, MD,MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt University Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Pediatrics', 'investigatorFullName': 'Seth Scholer', 'investigatorAffiliation': 'Vanderbilt University Medical Center'}}}}