Evaluation of the Effectiveness of the Teen Options to Prevent Pregnancy (T.O.P.P.) Program

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
OhioHealth Research and Innovation Institute
Nationwide Children's Hospital
Information provided by (Responsible Party):
Mathematica Policy Research, Inc.
ClinicalTrials.gov Identifier:
NCT01456793
First received: October 14, 2011
Last updated: April 28, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Pregnancy
Behavioral: Teen Options to Prevent Pregnancy (T.O.P.P.)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Evaluation of the Effectiveness of the Teen Options to Prevent Pregnancy (T.O.P.P.) Program

Further study details as provided by Mathematica Policy Research, Inc.:

Primary Outcome Measures:
  • Incidence of repeat pregnancy [ Time Frame: 30 months after baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Contraceptive Use [ Time Frame: 6 months after baseline ] [ Designated as safety issue: No ]
  • Contraceptive Use [ Time Frame: 18 months after baseline ] [ Designated as safety issue: No ]
  • Contraceptive Use [ Time Frame: 30 months after baseline ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: October 2011
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Teen Options to Prevent Pregnancy Behavioral: Teen Options to Prevent Pregnancy (T.O.P.P.)
Telephone-based care coordination and mobile contraceptive services
No Intervention: Usual care services

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   10 Years to 19 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 10 - 19 years old
  • Female
  • 28 weeks pregnant through 8 week post partum
  • Medicaid recipient
  • English speaking
  • Patient of OhioHealth
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01456793

Locations
United States, Ohio
OhioHealth Community Partnerships
Columbus, Ohio, United States, 43215
Sponsors and Collaborators
Mathematica Policy Research, Inc.
OhioHealth Research and Innovation Institute
Nationwide Children's Hospital
Investigators
Principal Investigator: Brian Goesling, PhD Mathematica Policy Research
Principal Investigator: Jack Stevens, PhD Nationwide Children's Hospital
Principal Investigator: Ngozi Osuagwu, MD OhioHealth
Principal Investigator: Kimberly V Smith, PhD Mathematica Policy Research
  More Information

No publications provided

Responsible Party: Mathematica Policy Research, Inc.
ClinicalTrials.gov Identifier: NCT01456793     History of Changes
Other Study ID Numbers: MPR-06549-1
Study First Received: October 14, 2011
Last Updated: April 28, 2014
Health Authority: United States: Department of Health and Human Services
United States: Institutional Review Board

Keywords provided by Mathematica Policy Research, Inc.:
Pregnancy prevention
Pregnancy
Birth
Contraceptive use
Adolescents

ClinicalTrials.gov processed this record on September 22, 2014