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

Overview

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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 2016

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.

Interventions

  • Behavioral: Teen Options to Prevent Pregnancy (T.O.P.P.)
    • Telephone-based care coordination and mobile contraceptive services

Arms, Groups and Cohorts

  • Experimental: Teen Options to Prevent Pregnancy
  • No Intervention: Usual care services

Clinical Trial Outcome Measures

Primary Measures

  • Incidence of repeat pregnancy
    • Time Frame: 30 months after baseline

Secondary Measures

  • Contraceptive Use
    • Time Frame: 6 months after baseline
  • Contraceptive Use
    • Time Frame: 18 months after baseline
  • Contraceptive Use
    • Time Frame: 30 months after baseline

Participating in This Clinical Trial

Inclusion Criteria

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

Gender Eligibility: Female

Minimum Age: 10 Years

Maximum Age: 19 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Mathematica Policy Research, Inc.
  • Collaborator
    • OhioHealth Research and Innovation Institute
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Brian Goesling, PhD, Principal Investigator, Mathematica Policy Research
    • Jack Stevens, PhD, Principal Investigator, Nationwide Children’s Hospital
    • Ngozi Osuagwu, MD, Principal Investigator, OhioHealth
    • Kimberly V Smith, PhD, Principal Investigator, Mathematica Policy Research

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