Evaluation of the Effectiveness of the Teen Options to Prevent Pregnancy (T.O.P.P.) Program
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Pregnancy |
Behavioral: Teen Options to Prevent Pregnancy (T.O.P.P.) |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Evaluation of the Effectiveness of the Teen Options to Prevent Pregnancy (T.O.P.P.) Program |
- Incidence of repeat pregnancy [ Time Frame: 30 months after baseline ] [ Designated as safety issue: No ]
- Contraceptive Use [ Time Frame: 6 months after baseline ] [ Designated as safety issue: No ]
- Contraceptive Use [ Time Frame: 18 months after baseline ] [ Designated as safety issue: No ]
- Contraceptive Use [ Time Frame: 30 months after baseline ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 600 |
| Study Start Date: | October 2011 |
| Estimated Study Completion Date: | March 2016 |
| Estimated Primary Completion Date: | March 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Teen Options to Prevent Pregnancy |
Behavioral: Teen Options to Prevent Pregnancy (T.O.P.P.)
Telephone-based care coordination and mobile contraceptive services
|
| No Intervention: Usual care services |
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.
Eligibility| Ages Eligible for Study: | 10 Years to 19 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 10 - 19 years old
- Female
- 28 weeks pregnant through 8 week post partum
- Medicaid recipient
- English speaking
- Patient of OhioHealth
Contacts and Locations| United States, Ohio | |
| OhioHealth Community Partnerships | |
| Columbus, Ohio, United States, 43215 | |
| Principal Investigator: | Brian Goesling, PhD | Mathematica Policy Research |
| Principal Investigator: | Jack Stevens, PhD | Nationwide Children's Hospital |
| Principal Investigator: | Ngozi Osuagwu, MD | OhioHealth |
| Principal Investigator: | Kimberly V Smith, PhD | Mathematica Policy Research |
More Information
No publications provided
| Responsible Party: | Mathematica Policy Research, Inc. |
| ClinicalTrials.gov Identifier: | NCT01456793 History of Changes |
| Other Study ID Numbers: | MPR-06549-1 |
| Study First Received: | October 14, 2011 |
| Last Updated: | March 28, 2013 |
| Health Authority: | United States: Department of Health and Human Services United States: Institutional Review Board |
Keywords provided by Mathematica Policy Research, Inc.:
|
Pregnancy prevention Pregnancy Birth Contraceptive use Adolescents |
ClinicalTrials.gov processed this record on June 18, 2013