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

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1017

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27707
        • innovation Research & Training

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Wait-list control
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.
Behavioral: Media Aware-Sexual Health
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
Change in media deconstruction skills assessed via questionnaire.
Time Frame: 2 weeks
2 weeks
Change in media deconstruction skills assessed via questionnaire.
Time Frame: 3 months
3 months
Change in perceived realism of media messages assessed via questionnaire.
Time Frame: 2 weeks
2 weeks
Change in perceived realism of media messages assessed via questionnaire.
Time Frame: 3 months
3 months
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
Change in media skepticism assessed via self-report questionnaire.
Time Frame: 3 months
3 months
Change in identification to media messages assessed via questionnaire.
Time Frame: 2 weeks
2 weeks
Change in identification to media messages assessed via questionnaire.
Time Frame: 3 months
3 months
Change in acceptance of dating violence norms assessed via questionnaire.
Time Frame: 2 weeks
2 weeks
Change in acceptance of dating violence norms assessed via questionnaire.
Time Frame: 3 months
3 months
Change in acceptance of gender role norms assessed via questionnaire.
Time Frame: 2 weeks
2 weeks
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Innovation Research & Training

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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.

General Publications

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 3, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 4, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 10, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 20, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 19, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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