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

March 6, 2017 updated by: Mathematica Policy Research, Inc.
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

598

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43215
        • OhioHealth Community Partnerships

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 19 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 10 - 19 years old
  • Female
  • 28 weeks pregnant through 8 week post partum
  • Medicaid recipient
  • English speaking
  • Patient of OhioHealth

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of repeat pregnancy
Time Frame: 30 months after baseline
30 months after baseline

Secondary Outcome Measures

Outcome Measure
Time Frame
Contraceptive Use
Time Frame: 6 months after baseline
6 months after baseline
Contraceptive Use
Time Frame: 18 months after baseline
18 months after baseline
Contraceptive Use
Time Frame: 30 months after baseline
30 months after baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mathematica Policy Research, Inc.

Collaborators

Nationwide Children's Hospital
OhioHealth Research and Innovation Institute

Investigators

  • Principal Investigator: Jack Stevens, PhD, Nationwide Children's Hospital
  • Principal Investigator: Ngozi Osuagwu, MD, OhioHealth
  • Principal Investigator: Kimberly V Smith, PhD, Mathematica Policy Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

October 14, 2011

First Submitted That Met QC Criteria

October 20, 2011

First Posted (Estimate)

October 21, 2011

Study Record Updates

Last Update Posted (Actual)

March 7, 2017

Last Update Submitted That Met QC Criteria

March 6, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MPR-06549-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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