Impact Evaluation of the Reducing the Risk Program | NCT02054026

Studies
Impact Evaluation of the Reducing the Risk Program

NCT02054026

Sponsor

Mathematica Policy Research, Inc.

Status

Completed

Last Update Posted

Apr 17, 2017Actual

Enrollment

2,220Actual

Phase

Not Applicable

Conditions

Sexual Behavior

Interventions

Reducing the Risk

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2013

Primary Completion Date

Dec 2016Actual

Completion Date

Dec 2016Actual

First Submitted Date

Jan 31, 2014

First Submission Date that Met QC Criteria

Jan 31, 2014

First Posted Date

Feb 4, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 13, 2017

Last Update Posted Date

Apr 17, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

2,220Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Reducing the Risk	Experimental	An eight-lesson (approximately eight-hour) version of Reducing the Risk	Behavioral: Reducing the Risk
Control	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Reducing the Risk	Behavioral		Reducing the Risk

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Sexual Initiation		2-years post intervention

Secondary Outcomes

Measure	Description	Time Frame
Sexual Initiation		1-year post intervention
Contraceptive use		1-year post intervention
Contraceptive use

Other Outcomes

Measure	Description	Time Frame
Attitudes towards healthy relationships and sexual activity		1-year post intervention
Attitudes towards healthy relationships and sexual activity		2-years post intervention

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

9th grader
Attends participating school

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Robert Wood, PhD	Mathematica Policy Research	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bardstown High School		Bardstown	Kentucky	40004	United States
Warren Central High School