NCT02054026

Brief Summary

The purpose of this study is to evaluate the effectiveness of an eight-hour version of Reducing the Risk on outcomes such as sexual initiation, condom and contraceptive use, number of sexual partners, and pregnancy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,220

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

13 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 31, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 4, 2014

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

April 17, 2017

Status Verified

April 1, 2017

Enrollment Period

3.3 years

First QC Date

January 31, 2014

Last Update Submit

April 13, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Sexual Initiation

    2-years post intervention

Secondary Outcomes (5)

  • Sexual Initiation

    1-year post intervention

  • Contraceptive use

    1-year post intervention

  • Contraceptive use

    2-years post intervention

  • Number of sexual partners

    1-year post intervention

  • Number of sexual partners

    2-years post intervention

Other Outcomes (6)

  • Attitudes towards healthy relationships and sexual activity

    1-year post intervention

  • Attitudes towards healthy relationships and sexual activity

    2-years post intervention

  • Knowledge of Sexually Transmitted Diseases

    1-year post intervention

  • +3 more other outcomes

Study Arms (2)

Reducing the Risk

EXPERIMENTAL

An eight-lesson (approximately eight-hour) version of Reducing the Risk

Behavioral: Reducing the Risk

Control

NO INTERVENTION

Interventions

Reducing the Risk

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • th grader
  • Attends participating school

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Bardstown High School

Bardstown, Kentucky, 40004, United States

Location

Warren Central High School

Bowling Green, Kentucky, 42101, United States

Location

Warren East High School

Bowling Green, Kentucky, 42101, United States

Location

Greenwood High School

Bowling Green, Kentucky, 42104, United States

Location

Central Hardin High School

Cecilia, Kentucky, 42724, United States

Location

Metcalfe County High School

Edmonton, Kentucky, 42129, United States

Location

Elizabethtown High School

Elizabethtown, Kentucky, 42701, United States

Location

Franklin-Simpson High School

Franklin, Kentucky, 42134, United States

Location

LaRue High School

Hodgenville, Kentucky, 42748, United States

Location

Marion County High School

Lebanon, Kentucky, 40033, United States

Location

North Hardin High School

Radcliff, Kentucky, 40160, United States

Location

Logan County High School

Russellville, Kentucky, 42276, United States

Location

Russellville Junior/Senior High School

Russellville, Kentucky, 42276, United States

Location

MeSH Terms

Conditions

Sexual Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Robert Wood, PhD

    Mathematica Policy Research

    STUDY DIRECTOR

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

January 31, 2014

First Posted

February 4, 2014

Study Start

August 1, 2013

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

April 17, 2017

Record last verified: 2017-04

Locations