NCT01565304

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,039

participants targeted

Target at P75+ for not_applicable pregnancy

Timeline
Completed

Started Jan 2012

Typical duration for not_applicable pregnancy

Geographic Reach
1 country

3 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 23, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 28, 2012

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

September 23, 2015

Status Verified

September 1, 2015

Enrollment Period

3.5 years

First QC Date

March 23, 2012

Last Update Submit

September 22, 2015

Conditions

PregnancySexually Transmitted Infections

Keywords

Teen pregnancySexually transmitted infectionsSexual risk behaviors

Outcome Measures

Primary Outcomes (2)

  • Consistent contraceptive use

    12 months

  • Sexual initiation

    12 months

Secondary Outcomes (4)

  • Knowledge of contraceptive use and reproductive health

    6 months

  • Intentions to delay sexual initiation and unprotected sex

    6 months

  • Attitudes toward sexual activity and contraceptive use

    6 months

  • Scores on scale of self-efficacy to avoid sexual risk behaviors

    6 months

Study Arms (2)

POWER Through Choices

EXPERIMENTAL

10-session group-based sexual education curriculum

Behavioral: POWER Through Choices

Usual services

NO INTERVENTION

No intervention

Interventions

POWER Through ChoicesBEHAVIORAL

10-session group-based sexual education curriculum

POWER Through Choices

Eligibility Criteria

Age13 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Resident of group foster care home

You may not qualify if:

  • Pregnant or parenting

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Kern County Superintendent of Schools

Bakersfield, California, 93301, United States

Location

Planned Parenthood of Maryland

Baltimore, Maryland, 21201, United States

Location

Oklahoma Institute for Child Advocacy

Oklahoma City, Oklahoma, 73118, United States

Location

MeSH Terms

Conditions

Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Communicable DiseasesInfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Roy Oman, PhD

    University of Oklahoma

    PRINCIPAL INVESTIGATOR

  • Sara Vesely, PhD

    University of Oklahoma

    PRINCIPAL INVESTIGATOR

  • Brian Goesling, 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

March 23, 2012

First Posted

March 28, 2012

Study Start

January 1, 2012

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

September 23, 2015

Record last verified: 2015-09

Locations

US(3)