PregnancyNCT01456793
Evaluation of the Effectiveness of the Teen Options to Prevent Pregnancy (T.O.P.P.) Program
A study testing Teen Options to Prevent Pregnancy (T.O.P.P.) in people with Pregnancy, run by Mathematica Policy Research, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 19 years, women only
- Conditions the study is for
- Pregnancy
- What is being tested?
- Teen Options to Prevent Pregnancy (T.O.P.P.)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 598 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 19 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 10 - 19 years old
- Female
- 28 weeks pregnant through 8 week post partum
- Medicaid recipient
- English speaking
- Patient of OhioHealth
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
OhioHealth Community Partnerships
Columbus, Ohio, 43215
About this study
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.
Read the 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.
- Conditions
- Pregnancy
- Being tested
- Teen Options to Prevent Pregnancy (T.O.P.P.)
- Keywords
- Pregnancy prevention, Pregnancy, Birth, Contraceptive use, Adolescents
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Teen Options to Prevent Pregnancy (T.O.P.P.)Behavioural
Telephone-based care coordination and mobile contraceptive services
| Study group | Role | What they receive |
|---|---|---|
| Teen Options to Prevent Pregnancy | Experimental | Not described Receives: Behavioral: Teen Options to Prevent Pregnancy (T.O.P.P.) |
| Usual care services | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of repeat pregnancy
Measured: 30 months after baseline
Secondary outcomes (3)
Contraceptive Use
Measured: 6 months after baseline
Contraceptive Use
Measured: 18 months after baseline
Contraceptive Use
Measured: 30 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 598 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mathematica Policy Research, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- OhioHealth Research and Innovation Institute, Nationwide Children's Hospital
- Responsible party
- Sponsor
- Investigators
- Brian Goesling, PhD, Principal investigator, Mathematica Policy ResearchJack Stevens, PhD, Principal investigator, Nationwide Children's HospitalNgozi Osuagwu, MD, Principal investigator, OhioHealthKimberly V Smith, PhD, Principal investigator, Mathematica Policy Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01456793
- Sponsor's protocol ID
- MPR-06549-1
- Status last verified
- Mar 2017
- First submitted
- 14 Oct 2011
- Last updated
- 7 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 31252347Stevens 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.
PubMed 28619692
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of the Teen Options to Prevent Pregnancy (T.O.P.P.) Program
- ClinicalTrials.gov ID
- NCT01456793
- Acronym / sponsor ID
- MPR-06549-1
- Conditions
- Pregnancy
- Keywords
- Pregnancy prevention, Pregnancy, Birth, Contraceptive use, Adolescents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 598 participants (actual)
- Lead sponsor
- Mathematica Policy Research, Inc.University, hospital or other
- Collaborators
- OhioHealth Research and Innovation Institute, Nationwide Children's Hospital
- Study start
- Oct 2011
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 21 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Teen Options to Prevent Pregnancy | Experimental | Behavioral: Teen Options to Prevent Pregnancy (T.O.P.P.) |
| Usual care services | No intervention | – |
Who may qualify
- Ages
- 10 to 19 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 10 - 19 years old
- Female
- 28 weeks pregnant through 8 week post partum
- Medicaid recipient
- English speaking
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Teen Options to Prevent Pregnancy (T.O.P.P.)Telephone-based care coordination and mobile contraceptive services | Behavioural | Teen Options to Prevent Pregnancy |
Primary outcome
Incidence of repeat pregnancy
Time frame: 30 months after baseline
3 secondary outcomes
Contraceptive Use
Time frame: 6 months after baseline
Contraceptive Use
Time frame: 18 months after baseline
Contraceptive Use
Time frame: 30 months after baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2017.
- Derived from this study: PubMed 31252347Stevens 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.
- Derived from this study: PubMed 28619692Stevens 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian Goesling, PhD principal investigator
Mathematica Policy Research
Jack Stevens, PhD principal investigator
Nationwide Children's Hospital
Ngozi Osuagwu, MD principal investigator
OhioHealth
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Teen Options to Prevent Pregnancy (T.O.P.P.) in people with Pregnancy, run by Mathematica Policy Research, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of repeat pregnancy (time frame: 30 months after baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01456793, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2017.