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

Study Overview
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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.

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

Conditions
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Pregnancy

Intervention / Treatment
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* Behavioral: Teen Options to Prevent Pregnancy (T.O.P.P.)


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 19 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Teen Options to Prevent Pregnancy<br> | Behavioral: Teen Options to Prevent Pregnancy (T.O.P.P.)<br>* Telephone-based care coordination and mobile contraceptive services<br>|
| No Intervention: Usual care services<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of repeat pregnancy |  | 30 months after baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Contraceptive Use |  | 6 months after baseline | 
| Contraceptive Use |  | 18 months after baseline | 
| Contraceptive Use |  | 30 months after baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pregnancy prevention, Pregnancy, Birth, Contraceptive use, Adolescents