PregnancyNCT01565304
Evaluation of the Effectiveness of the POWER Through Choices Program
A study testing POWER Through Choices in people with Pregnancy and Sexually Transmitted Infections, run by Mathematica Policy Research, Inc. at 3 sites in United States.
Trial summary
The purpose of this study is to evaluate the effectiveness of the POWER Through Choices (PTC) curriculum in increasing contraceptive use and delaying sexual initiation among youth living in group foster care homes. Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Pregnancy, Sexually Transmitted Infections
- What is being tested?
- POWER Through Choices
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,039 participants
- Where
- 3 sitesUnited States
- Study dates
- Jan 2012to Jul 2015
- 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 13 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Resident of group foster care home
Who cannot join
- Pregnant or parenting
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Kern County Superintendent of Schools
Bakersfield, California, 93301
Planned Parenthood of Maryland
Baltimore, Maryland, 21201
Oklahoma Institute for Child Advocacy
Oklahoma City, Oklahoma, 73118
About this study
The purpose of this study is to evaluate the effectiveness of the POWER Through Choices (PTC) curriculum in increasing contraceptive use and delaying sexual initiation among youth living in group foster care homes.
Read the detailed description
Youth in foster care are at especially high risk for teen pregnancy and associated sexual risk behaviors. The POWER Through Choices (PTC) program is a 10-session sexuality curriculum that aims to increase contraceptive use and delay sexual initiation by empowering youth to make healthy, positive choices about their sexual behaviors. This study uses a cluster randomized design to compare the effectiveness of PTC to usual programs and services provided to youth living in group foster care homes. Study participants will be youth living in group foster homes recruited in four locations: Kern County, CA; Cook County, IL; Baltimore County, MD; and Oklahoma (statewide). The study is being conducted as part of the national Evaluation of Adolescent Pregnancy Prevention Approaches funded by the Office of Adolescent Health in the U.S. Department of Health and Human Services.
- Conditions
- Pregnancy, Sexually Transmitted Infections
- Being tested
- POWER Through Choices
- Keywords
- Teen pregnancy, Sexually transmitted infections, Sexual risk behaviors
- Medical subject headings
- Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
POWER Through ChoicesBehavioural
10-session group-based sexual education curriculum
| Study group | Role | What they receive |
|---|---|---|
| POWER Through Choices | Experimental | 10-session group-based sexual education curriculum Receives: Behavioral: POWER Through Choices |
| Usual services | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Consistent contraceptive use
Measured: 12 months
Sexual initiation
Measured: 12 months
Secondary outcomes (4)
Knowledge of contraceptive use and reproductive health
Measured: 6 months
Intentions to delay sexual initiation and unprotected sex
Measured: 6 months
Attitudes toward sexual activity and contraceptive use
Measured: 6 months
Scores on scale of self-efficacy to avoid sexual risk behaviors
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2012 (estimated)
- Study startJan 2012
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 1,039 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mathematica Policy Research, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oklahoma
- Responsible party
- Sponsor
- Investigators
- Roy Oman, PhD, Principal investigator, University of OklahomaSara Vesely, PhD, Principal investigator, University of OklahomaBrian Goesling, PhD, Principal investigator, Mathematica Policy Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01565304
- Sponsor's protocol ID
- MPR-06549-03
- Status last verified
- Sep 2015
- First submitted
- 23 Mar 2012
- Last updated
- 23 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of the POWER Through Choices Program
- ClinicalTrials.gov ID
- NCT01565304
- Acronym / sponsor ID
- MPR-06549-03
- Conditions
- Pregnancy, Sexually Transmitted Infections
- Keywords
- Teen pregnancy, Sexually transmitted infections, Sexual risk behaviors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,039 participants (actual)
- Lead sponsor
- Mathematica Policy Research, Inc.University, hospital or other
- Collaborators
- University of Oklahoma
- Study start
- Jan 2012
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 28 Mar 2012 (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 POWER Through Choices (PTC) curriculum in increasing contraceptive use and delaying sexual initiation among youth living in group foster care homes.
Detailed description
Youth in foster care are at especially high risk for teen pregnancy and associated sexual risk behaviors. The POWER Through Choices (PTC) program is a 10-session sexuality curriculum that aims to increase contraceptive use and delay sexual initiation by empowering youth to make healthy, positive choices about their sexual behaviors. This study uses a cluster randomized design to compare the effectiveness of PTC to usual programs and services provided to youth living in group foster care homes. Study participants will be youth living in group foster homes recruited in four locations: Kern County, CA; Cook County, IL; Baltimore County, MD; and Oklahoma (statewide). The study is being conducted as part of the national Evaluation of Adolescent Pregnancy Prevention Approaches funded by the Office of Adolescent Health in the U.S. Department of Health and Human Services.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| POWER Through Choices | Experimental | Behavioral: POWER Through Choices10-session group-based sexual education curriculum |
| Usual services | No intervention | –No intervention |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Resident of group foster care home
Key exclusion criteria (1 listed)
- Pregnant or parenting
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 |
|---|---|---|
| POWER Through Choices10-session group-based sexual education curriculum | Behavioural | POWER Through Choices |
Primary outcome
Consistent contraceptive use
Time frame: 12 months
Sexual initiation
Time frame: 12 months
4 secondary outcomes
Knowledge of contraceptive use and reproductive health
Time frame: 6 months
Intentions to delay sexual initiation and unprotected sex
Time frame: 6 months
Attitudes toward sexual activity and contraceptive use
Time frame: 6 months
Scores on scale of self-efficacy to avoid sexual risk behaviors
Time frame: 6 months
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 23 Sep 2015.
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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.
Roy Oman, PhD principal investigator
University of Oklahoma
Sara Vesely, PhD principal investigator
University of Oklahoma
Brian Goesling, PhD principal investigator
Mathematica Policy Research
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing POWER Through Choices in people with Pregnancy and Sexually Transmitted Infections, run by Mathematica Policy Research, Inc. at 3 sites 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 1 inclusion and 1 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 23 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Consistent contraceptive use (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Sep 2015.