Overview

This trial is active, not recruiting.

Condition pregnancy
Treatment teen options to prevent pregnancy (t.o.p.p.)
Sponsor Mathematica Policy Research, Inc.
Collaborator OhioHealth Research and Innovation Institute
Start date October 2011
End date September 2016
Trial size 598 participants
Trial identifier NCT01456793, MPR-06549-1

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
teen options to prevent pregnancy (t.o.p.p.)
Telephone-based care coordination and mobile contraceptive services
(No Intervention)

Primary Outcomes

Measure
Incidence of repeat pregnancy
time frame: 30 months after baseline

Secondary Outcomes

Measure
Contraceptive Use
time frame: 6 months after baseline
Contraceptive Use
time frame: 18 months after baseline
Contraceptive Use
time frame: 30 months after baseline

Eligibility Criteria

Female participants from 10 years up to 19 years old.

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

Additional Information

Official title Evaluation of the Effectiveness of the Teen Options to Prevent Pregnancy (T.O.P.P.) Program
Principal investigator Brian Goesling, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Mathematica Policy Research, Inc..