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Completed

NCT Number: NCT01456793

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

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.

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Key information

Conditions

Pregnancy

Age range

10 year–19 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

OhioHealth Community Partnerships

Columbus, Ohio, 43215, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Teen Options to Prevent Pregnancy (T.O.P.P.)

Behavioral

Telephone-based care coordination and mobile contraceptive services

Primary outcomes

  1. Incidence of repeat pregnancy

    Time frame: 30 months after baseline

Secondary outcomes

  1. Contraceptive Use

    Time frame: 6 months after baseline

  2. Contraceptive Use

    Time frame: 18 months after baseline

  3. Contraceptive Use

    Time frame: 30 months after baseline

Sponsors and collaborators

Lead sponsor

Mathematica Policy Research, Inc.

Other

Collaborators

  • Nationwide Children's Hospital
  • OhioHealth Research and Innovation Institute

Registry information

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Oct 21, 2011
Registry last updated
Mar 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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