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

NCT ID: NCT01456793

Last Updated: 2017-03-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

598 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2016-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Teen Options to Prevent Pregnancy

Group Type EXPERIMENTAL

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

Intervention Type BEHAVIORAL

Telephone-based care coordination and mobile contraceptive services

Usual care services

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Telephone-based care coordination and mobile contraceptive services

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

10 Years

Maximum Eligible Age

19 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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OhioHealth Research and Innovation Institute

UNKNOWN

Sponsor Role collaborator

Nationwide Children's Hospital

OTHER

Sponsor Role collaborator

Mathematica Policy Research, Inc.

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Brian Goesling, PhD

Role: PRINCIPAL_INVESTIGATOR

Mathematica Policy Research

Jack Stevens, PhD

Role: PRINCIPAL_INVESTIGATOR

Nationwide Children's Hospital

Ngozi Osuagwu, MD

Role: PRINCIPAL_INVESTIGATOR

OhioHealth

Kimberly V Smith, PhD

Role: PRINCIPAL_INVESTIGATOR

Mathematica Policy Research

Locations

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OhioHealth Community Partnerships

Columbus, Ohio, United States

Site Status

Countries

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United States

References

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Stevens J, Rotz D, Goesling B. Brief report: Assessing the risk of reporting bias in a RCT for adolescent mothers. J Adolesc. 2019 Jul;74:197-200. doi: 10.1016/j.adolescence.2019.06.011. Epub 2019 Jun 26.

Reference Type DERIVED
PMID: 31252347 (View on PubMed)

Stevens J, Lutz R, Osuagwu N, Rotz D, Goesling B. A randomized trial of motivational interviewing and facilitated contraceptive access to prevent rapid repeat pregnancy among adolescent mothers. Am J Obstet Gynecol. 2017 Oct;217(4):423.e1-423.e9. doi: 10.1016/j.ajog.2017.06.010. Epub 2017 Jun 12.

Reference Type DERIVED
PMID: 28619692 (View on PubMed)

Other Identifiers

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MPR-06549-1

Identifier Type: -

Identifier Source: org_study_id

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