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

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01456793
• Other study ID #: MPR-06549-1
• Status: Completed
• Phase: N/A
• First received: October 14, 2011
• Last updated: March 6, 2017
• Start date: October 2011
• Est. completion date: September 2016

Study information

• Verified date: March 2017
• Source: Mathematica Policy Research, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 598
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 10 Years to 19 Years

Eligibility

Inclusion Criteria:

• 10 - 19 years old

• Female

• 28 weeks pregnant through 8 week post partum

• Medicaid recipient

• English speaking

• Patient of OhioHealth

Related Conditions & MeSH terms

• Pregnancy

Intervention

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

Locations

Country	Name	City	State
United States	OhioHealth Community Partnerships	Columbus	Ohio

Sponsors (3)

Lead Sponsor	Collaborator
Mathematica Policy Research, Inc.	Nationwide Children's Hospital, OhioHealth Research and Innovation Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of repeat pregnancy		30 months after baseline
Secondary	Contraceptive Use		6 months after baseline
Secondary	Contraceptive Use		18 months after baseline
Secondary	Contraceptive Use		30 months after baseline