NCT01456793

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
598

participants targeted

Target at P75+ for not_applicable pregnancy

Timeline
Completed

Started Oct 2011

Longer than P75 for not_applicable pregnancy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

October 14, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 21, 2011

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

March 7, 2017

Status Verified

March 1, 2017

Enrollment Period

4.9 years

First QC Date

October 14, 2011

Last Update Submit

March 6, 2017

Conditions

Keywords

Pregnancy preventionPregnancyBirthContraceptive useAdolescents

Outcome Measures

Primary Outcomes (1)

  • Incidence of repeat pregnancy

    30 months after baseline

Secondary Outcomes (3)

  • Contraceptive Use

    6 months after baseline

  • Contraceptive Use

    18 months after baseline

  • Contraceptive Use

    30 months after baseline

Study Arms (2)

Teen Options to Prevent Pregnancy

EXPERIMENTAL
Behavioral: Teen Options to Prevent Pregnancy (T.O.P.P.)

Usual care services

NO INTERVENTION

Interventions

Telephone-based care coordination and mobile contraceptive services

Teen Options to Prevent Pregnancy

Eligibility Criteria

Age10 Years - 19 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • years old
  • Female
  • weeks pregnant through 8 week post partum
  • Medicaid recipient
  • English speaking
  • Patient of OhioHealth

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

OhioHealth Community Partnerships

Columbus, Ohio, 43215, United States

Location

Related Publications (2)

  • 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.

  • 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.

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 14, 2011

First Posted

October 21, 2011

Study Start

October 1, 2011

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

March 7, 2017

Record last verified: 2017-03

Locations