- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02359422
Evaluation of a Middle School Comprehensive Sexual Health Media Literacy Education Program (MASH)
November 19, 2015 updated by: Innovation Research & Training
Randomized Control Trial Efficacy Study of a Comprehensive Sexual Health Media Literacy Education Program for Middle School Students
The purpose of this study is to conduct a randomized controlled trial of a media literacy education program for middle school students with the goal of enhancing decision-making skills to prevent early and risky sexual behavior and teen pregnancy, and encourage healthy relationships.
Study Overview
Study Type
Interventional
Enrollment (Actual)
1017
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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North Carolina
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Durham, North Carolina, United States, 27707
- innovation Research & Training
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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
10 years to 15 years (CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Must be able to read and write in English
Exclusion Criteria:
- None
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
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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No Intervention: Wait-list control
|
|
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Experimental: Media Aware-Sexual Health
10-lesson middle school, comprehensive sexual health program developed based upon the Message Interpretation Processing model designed to increase critical thinking skills about media messages and reduce risky sexual behaviors.
|
10-lesson middle school, comprehensive sexual health media literacy education program.
Each lesson take approximately 50 minutes to teach and will be taught every school day for 2 weeks.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in self-reported sexual activity assessed via questionnaire.
Time Frame: 2 weeks
|
2 weeks
|
|
Change in self-reported sexual activity assessed via questionnaire.
Time Frame: 3 months
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in self-reported intentions to engage in sexual activity assessed via questionnaire.
Time Frame: 2 weeks
|
2 weeks
|
|
Change in self-reported intentions to engage in sexual activity assessed via questionnaire.
Time Frame: 3 months
|
3 months
|
|
Change in self-reported attitude toward sexual activity assessed via questionnaire.
Time Frame: 2 weeks
|
2 weeks
|
|
Change in self-reported attitude toward sexual activity assessed via questionnaire.
Time Frame: 3 months
|
3 months
|
|
Change in self-reported attitudes toward contraception assessed via questionnaire.
Time Frame: 2 weeks
|
2 weeks
|
|
Change in self-reported attitudes toward contraception assessed via questionnaire.
Time Frame: 3 months
|
3 months
|
|
Change in self-reported attitude toward sexual communication assessed via questionnaire.
Time Frame: 2 weeks
|
2 weeks
|
|
Change in self-reported attitude toward sexual communication assessed via questionnaire.
Time Frame: 3 months
|
3 months
|
|
Change in self-reported perceived norms regarding sexual activity assessed via questionnaire.
Time Frame: 2 weeks
|
2 weeks
|
|
Change in self-reported perceived norms regarding sexual activity assessed via questionnaire.
Time Frame: 3 months
|
3 months
|
|
Change in self-reported perceived norms regarding contraception assessed via questionnaire.
Time Frame: 2 weeks
|
2 weeks
|
|
Change in self-reported perceived norms regarding contraception assessed via questionnaire.
Time Frame: 3 months
|
3 months
|
|
Change in self-reported perceived norms regarding sexual communication assessed via questionnaire.
Time Frame: 2 weeks
|
2 weeks
|
|
Change in self-reported perceived norms regarding sexual communication assessed via questionnaire.
Time Frame: 3 months
|
3 months
|
|
Change in self-reported self-efficacy to refusal sexual activity assessed via questionnaire.
Time Frame: 2 weeks
|
2 weeks
|
|
Change in self-reported self-efficacy to refusal sexual activity assessed via questionnaire.
Time Frame: 3 months
|
3 months
|
|
Change in self-reported self-efficacy to use contraception assessed via questionnaire.
Time Frame: 2 weeks
|
2 weeks
|
|
Change in self-reported self-efficacy to use contraception assessed via questionnaire.
Time Frame: 3 months
|
3 months
|
|
Change in self-reported self-efficacy for sexual communication assessed via questionnaire.
Time Frame: 2 weeks
|
2 weeks
|
|
Change in self-reported self-efficacy for sexual communication assessed via questionnaire.
Time Frame: 3 months
|
3 months
|
|
Change in self-reported intentions for condom/contraception use assessed via questionnaire.
Time Frame: 2 weeks
|
2 weeks
|
|
Change in self-reported intentions for condom/contraception use assessed via questionnaire.
Time Frame: 3 months
|
3 months
|
|
Change in self-reported intentions for sexual communication assessed via questionnaire.
Time Frame: 2 weeks
|
2 weeks
|
|
Change in self-reported intentions for sexual communication assessed via questionnaire.
Time Frame: 3 months
|
3 months
|
Other Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in media deconstruction skills assessed via questionnaire.
Time Frame: 2 weeks
|
2 weeks
|
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Change in media deconstruction skills assessed via questionnaire.
Time Frame: 3 months
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3 months
|
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Change in perceived realism of media messages assessed via questionnaire.
Time Frame: 2 weeks
|
2 weeks
|
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Change in perceived realism of media messages assessed via questionnaire.
Time Frame: 3 months
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3 months
|
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Change in perceived similarity to media messages assessed via questionnaire.
Time Frame: 2 weeks
|
2 weeks
|
|
Change in perceived similarity to media messages assessed via questionnaire.
Time Frame: 3 months
|
3 months
|
|
Change in perceived desirability of media messages assessed via questionnaire.
Time Frame: 2 weeks
|
2 weeks
|
|
Change in perceived desirability of media messages assessed via questionnaire.
Time Frame: 3 months
|
3 months
|
|
Change in media skepticism assessed via self-report questionnaire.
Time Frame: 2 weeks
|
2 weeks
|
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Change in media skepticism assessed via self-report questionnaire.
Time Frame: 3 months
|
3 months
|
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Change in identification to media messages assessed via questionnaire.
Time Frame: 2 weeks
|
2 weeks
|
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Change in identification to media messages assessed via questionnaire.
Time Frame: 3 months
|
3 months
|
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Change in acceptance of dating violence norms assessed via questionnaire.
Time Frame: 2 weeks
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2 weeks
|
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Change in acceptance of dating violence norms assessed via questionnaire.
Time Frame: 3 months
|
3 months
|
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Change in acceptance of gender role norms assessed via questionnaire.
Time Frame: 2 weeks
|
2 weeks
|
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Change in acceptance of gender role norms assessed via questionnaire.
Time Frame: 3 months
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Tracy M Scull, PhD, innovation Research & Training
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
April 1, 2014
Primary Completion (Actual)
August 1, 2015
Study Completion (Actual)
August 1, 2015
Study Registration Dates
First Submitted
September 3, 2014
First Submitted That Met QC Criteria
February 4, 2015
First Posted (Estimate)
February 10, 2015
Study Record Updates
Last Update Posted (Estimate)
November 20, 2015
Last Update Submitted That Met QC Criteria
November 19, 2015
Last Verified
November 1, 2015
More Information
Terms related to this study
Other Study ID Numbers
- iRT-2R44HD061193-02-RCT
- 2R44HD061193-02 (U.S. NIH Grant/Contract)
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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