Clinical trial NCT01456793: Evaluation of the Effectiveness of the Teen Options to Prevent Pregnancy (T.O.P.P.) Program
Official title: Evaluation of the Effectiveness of the Teen Options to Prevent Pregnancy (T.O.P.P.) Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Keywords: Pregnancy prevention
Pregnancy
Birth
Contraceptive use
Adolescents
Lead sponsor: Mathematica Policy Research, Inc.
Sponsor class: OTHER
Collaborators: name: OhioHealth Research and Innovation Institute
name: Nationwide Children's Hospital
First posted: 2011-10-21
Enrollment: 598
Sex: FEMALE
Minimum age (years): 10
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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 criteria: Inclusion Criteria:

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

Primary outcomes:
measure: Incidence of repeat pregnancy
timeFrame: 30 months after baseline
Secondary outcomes:
measure: Contraceptive Use
timeFrame: 6 months after baseline
measure: Contraceptive Use
timeFrame: 18 months after baseline
measure: Contraceptive Use
timeFrame: 30 months after baseline
Other outcomes:
Locations:
city: Columbus
country: United States
facility: OhioHealth Community Partnerships
state: Ohio
Study officials:
affiliation: Mathematica Policy Research
name: Brian Goesling, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Nationwide Children's Hospital
name: Jack Stevens, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: OhioHealth
name: Ngozi Osuagwu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mathematica Policy Research
name: Kimberly V Smith, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.