- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01565304
Evaluation of the Effectiveness of the POWER Through Choices Program
September 22, 2015 updated by: Mathematica Policy Research, Inc.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
1039
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Bakersfield, California, United States, 93301
- Kern County Superintendent of Schools
-
-
Maryland
-
Baltimore, Maryland, United States, 21201
- Planned Parenthood of Maryland
-
-
Oklahoma
-
Oklahoma City, Oklahoma, United States, 73118
- Oklahoma Institute for Child Advocacy
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
13 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Resident of group foster care home
Exclusion Criteria:
- Pregnant or parenting
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: POWER Through Choices
10-session group-based sexual education curriculum
|
10-session group-based sexual education curriculum
|
No Intervention: Usual services
No intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Consistent contraceptive use
Time Frame: 12 months
|
12 months
|
Sexual initiation
Time Frame: 12 months
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Knowledge of contraceptive use and reproductive health
Time Frame: 6 months
|
6 months
|
Intentions to delay sexual initiation and unprotected sex
Time Frame: 6 months
|
6 months
|
Attitudes toward sexual activity and contraceptive use
Time Frame: 6 months
|
6 months
|
Scores on scale of self-efficacy to avoid sexual risk behaviors
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Roy Oman, PhD, University of Oklahoma
- Principal Investigator: Sara Vesely, PhD, University of Oklahoma
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2012
Primary Completion (Actual)
July 1, 2015
Study Completion (Actual)
July 1, 2015
Study Registration Dates
First Submitted
March 23, 2012
First Submitted That Met QC Criteria
March 26, 2012
First Posted (Estimate)
March 28, 2012
Study Record Updates
Last Update Posted (Estimate)
September 23, 2015
Last Update Submitted That Met QC Criteria
September 22, 2015
Last Verified
September 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MPR-06549-03
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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