Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2025-12-27 @ 11:34 AM
Study NCT ID:
NCT01456793
Status:
COMPLETED
Last Update Posted:
2017-03-07
First Post:
2011-10-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Effectiveness of the Teen Options to Prevent Pregnancy (T.O.P.P.) Program
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': 598}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-06', 'studyFirstSubmitDate': '2011-10-14', 'studyFirstSubmitQcDate': '2011-10-20', 'lastUpdatePostDateStruct': {'date': '2017-03-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-10-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of repeat pregnancy', 'timeFrame': '30 months after baseline'}], 'secondaryOutcomes': [{'measure': 'Contraceptive Use', 'timeFrame': '6 months after baseline'}, {'measure': 'Contraceptive Use', 'timeFrame': '18 months after baseline'}, {'measure': 'Contraceptive Use', 'timeFrame': '30 months after baseline'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pregnancy prevention', 'Pregnancy', 'Birth', 'Contraceptive use', 'Adolescents'], 'conditions': ['Pregnancy']}, 'referencesModule': {'references': [{'pmid': '31252347', 'type': 'DERIVED', 'citation': 'Stevens J, Rotz D, Goesling B. Brief report: Assessing the risk of reporting bias in a RCT for adolescent mothers. J Adolesc. 2019 Jul;74:197-200. doi: 10.1016/j.adolescence.2019.06.011. Epub 2019 Jun 26.'}, {'pmid': '28619692', 'type': 'DERIVED', 'citation': 'Stevens J, Lutz R, Osuagwu N, Rotz D, Goesling B. A randomized trial of motivational interviewing and facilitated contraceptive access to prevent rapid repeat pregnancy among adolescent mothers. Am J Obstet Gynecol. 2017 Oct;217(4):423.e1-423.e9. doi: 10.1016/j.ajog.2017.06.010. Epub 2017 Jun 12.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effectiveness of the Teen Options to Prevent Pregnancy (T.O.P.P.) program in increasing contraceptive use and reducing repeat pregnancies among pregnant and parenting adolescents in central Ohio.', 'detailedDescription': "The risk for teen pregnancy is especially high among teen mothers, leading, in some cases, to unsafe intervals between teen births. The Teen Options to Prevent Pregnancy (T.O.P.P.) program is an 18-month clinic-based program that aims to reduce repeat pregnancies among pregnant and parenting adolescents by providing telephone-based care coordination and mobile contraceptive services to this high-risk population. This study uses a randomized controlled design to compare the effectiveness of T.O.P.P. versus usual care provided to patients at participating clinics. Study participants will be adolescent mothers between the ages of 10 to 19 recruited through seven OhioHealth women's health clinics and three OhioHealth hospitals covering seven counties in central Ohio. This study is being conducted as part of the national Evaluation of Adolescent Pregnancy Prevention Approaches funded by the U.S. Department of Health and Human Services' Office of Adolescent Health."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '19 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 10 - 19 years old\n* Female\n* 28 weeks pregnant through 8 week post partum\n* Medicaid recipient\n* English speaking\n* Patient of OhioHealth'}, 'identificationModule': {'nctId': 'NCT01456793', 'briefTitle': 'Evaluation of the Effectiveness of the Teen Options to Prevent Pregnancy (T.O.P.P.) Program', 'organization': {'class': 'OTHER', 'fullName': 'Mathematica Policy Research, Inc.'}, 'officialTitle': 'Evaluation of the Effectiveness of the Teen Options to Prevent Pregnancy (T.O.P.P.) Program', 'orgStudyIdInfo': {'id': 'MPR-06549-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Teen Options to Prevent Pregnancy', 'interventionNames': ['Behavioral: Teen Options to Prevent Pregnancy (T.O.P.P.)']}, {'type': 'NO_INTERVENTION', 'label': 'Usual care services'}], 'interventions': [{'name': 'Teen Options to Prevent Pregnancy (T.O.P.P.)', 'type': 'BEHAVIORAL', 'description': 'Telephone-based care coordination and mobile contraceptive services', 'armGroupLabels': ['Teen Options to Prevent Pregnancy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43215', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'OhioHealth Community Partnerships', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'overallOfficials': [{'name': 'Brian Goesling, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mathematica Policy Research'}, {'name': 'Jack Stevens, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Nationwide Children's Hospital"}, {'name': 'Ngozi Osuagwu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'OhioHealth'}, {'name': 'Kimberly V Smith, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mathematica Policy Research'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mathematica Policy Research, Inc.', 'class': 'OTHER'}, 'collaborators': [{'name': 'OhioHealth Research and Innovation Institute', 'class': 'UNKNOWN'}, {'name': "Nationwide Children's Hospital", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}