- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02052830
Impact Evaluation of the Wise Guys Program
April 13, 2017 updated by: Mathematica Policy Research, Inc.
The purpose of this study is to evaluate the impact of the Wise Guys program on the delaying sexual initiation on adolescent males in Eastern Iowa.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
This study uses a randomized controlled design to compare the impacts of the Wise Guys Program to the "business-as-usual" school curriculum.
The Wise Guys multi-session curriculum is delivered in different formats that range in length from 5 to 12 weeks and topics covered include communication and masculinity, dating violence, abstinence and contraception, and sexually transmitted infections.
Study participants are 7th grade boys attending a participating school in either the Davenport Iowa or North Scott Community school districts.
This study is being conducted as part of the national Personal Responsibility Education Program evaluation funded by Administration for Children and Families within the U.S. Department of Health and Human Services.
Study Type
Interventional
Enrollment (Actual)
737
Phase
- Not Applicable
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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- 7th grade student in participating schools
- Male
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: Wise Guys
A sexual health and male responsibility program for adolescent males
|
Multi-session curriculum delivered in different formats that range in length from 5 to 12 weeks and topics covered include communication and masculinity, dating violence, abstinence and contraception, and sexually transmitted infections.
|
|
No Intervention: Control
Business as usual sexual education in schools
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Sexual initiation
Time Frame: 24 months post-intervention
|
24 months post-intervention
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Sexual initiation
Time Frame: 6 months post-intervention
|
6 months post-intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Robert Wood, PhD, Mathematica Policy Research
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 (Actual)
August 1, 2013
Primary Completion (Anticipated)
January 1, 2018
Study Completion (Anticipated)
January 1, 2018
Study Registration Dates
First Submitted
January 30, 2014
First Submitted That Met QC Criteria
January 30, 2014
First Posted (Estimate)
February 3, 2014
Study Record Updates
Last Update Posted (Actual)
April 17, 2017
Last Update Submitted That Met QC Criteria
April 13, 2017
Last Verified
September 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PRP699101
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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