Evaluation of the Effectiveness of the POWER Through Choices Program

Pregnancy Clinical Trial

Official title:

Evaluation of the Effectiveness of the POWER Through Choices Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01565304
• Other study ID #: MPR-06549-03
• Status: Completed
• Phase: N/A
• First received: March 23, 2012
• Last updated: September 22, 2015
• Start date: January 2012
• Est. completion date: July 2015

Study information

• Verified date: September 2015
• Source: Mathematica Policy Research, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1039
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years to 18 Years

Eligibility

Inclusion Criteria:

• Resident of group foster care home

Exclusion Criteria:

• Pregnant or parenting

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pregnancy
• Sexually Transmitted Diseases
• Sexually Transmitted Infections

Intervention

Behavioral:
• POWER Through Choices
10-session group-based sexual education curriculum

Locations

Country	Name	City	State
United States	Kern County Superintendent of Schools	Bakersfield	California
United States	Planned Parenthood of Maryland	Baltimore	Maryland
United States	Oklahoma Institute for Child Advocacy	Oklahoma City	Oklahoma

Sponsors (2)

Lead Sponsor	Collaborator
Mathematica Policy Research, Inc.	University of Oklahoma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Consistent contraceptive use		12 months	No
Primary	Sexual initiation		12 months	No
Secondary	Knowledge of contraceptive use and reproductive health		6 months	No
Secondary	Intentions to delay sexual initiation and unprotected sex		6 months	No
Secondary	Attitudes toward sexual activity and contraceptive use		6 months	No
Secondary	Scores on scale of self-efficacy to avoid sexual risk behaviors		6 months	No