Safe SexMASHNCT02359422
Evaluation of a Middle School Comprehensive Sexual Health Media Literacy Education Program
A study testing Media Aware-Sexual Health in people with Safe Sex, run by Innovation Research & Training at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 10 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Safe Sex
- What is being tested?
- Media Aware-Sexual Health
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,017 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Aug 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Must be able to read and write in English
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
innovation Research & Training
Durham, North Carolina, 27707
About this study
Official title: 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.
- Conditions
- Safe Sex
- Being tested
- Media Aware-Sexual Health
- Medical subject headings
- Safe Sex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Media Aware-Sexual HealthBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Media Aware-Sexual Health | Experimental | 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. Receives: Behavioral: Media Aware-Sexual Health |
| Wait-list control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in self-reported sexual activity assessed via questionnaire.
Measured: 2 weeks
Change in self-reported sexual activity assessed via questionnaire.
Measured: 3 months
Secondary outcomes (24)
Change in self-reported intentions to engage in sexual activity assessed via questionnaire.
Measured: 2 weeks
Change in self-reported intentions to engage in sexual activity assessed via questionnaire.
Measured: 3 months
Change in self-reported attitude toward sexual activity assessed via questionnaire.
Measured: 2 weeks
Change in self-reported attitude toward sexual activity assessed via questionnaire.
Measured: 3 months
Change in self-reported attitudes toward contraception assessed via questionnaire.
Measured: 2 weeks
Change in self-reported attitudes toward contraception assessed via questionnaire.
Measured: 3 months
Change in self-reported attitude toward sexual communication assessed via questionnaire.
Measured: 2 weeks
Change in self-reported attitude toward sexual communication assessed via questionnaire.
Measured: 3 months
Change in self-reported perceived norms regarding sexual activity assessed via questionnaire.
Measured: 2 weeks
Change in self-reported perceived norms regarding sexual activity assessed via questionnaire.
Measured: 3 months
Change in self-reported perceived norms regarding contraception assessed via questionnaire.
Measured: 2 weeks
Change in self-reported perceived norms regarding contraception assessed via questionnaire.
Measured: 3 months
Change in self-reported perceived norms regarding sexual communication assessed via questionnaire.
Measured: 2 weeks
Change in self-reported perceived norms regarding sexual communication assessed via questionnaire.
Measured: 3 months
Change in self-reported self-efficacy to refusal sexual activity assessed via questionnaire.
Measured: 2 weeks
Change in self-reported self-efficacy to refusal sexual activity assessed via questionnaire.
Measured: 3 months
Change in self-reported self-efficacy to use contraception assessed via questionnaire.
Measured: 2 weeks
Change in self-reported self-efficacy to use contraception assessed via questionnaire.
Measured: 3 months
Change in self-reported self-efficacy for sexual communication assessed via questionnaire.
Measured: 2 weeks
Change in self-reported self-efficacy for sexual communication assessed via questionnaire.
Measured: 3 months
Change in self-reported intentions for condom/contraception use assessed via questionnaire.
Measured: 2 weeks
Change in self-reported intentions for condom/contraception use assessed via questionnaire.
Measured: 3 months
Change in self-reported intentions for sexual communication assessed via questionnaire.
Measured: 2 weeks
Change in self-reported intentions for sexual communication assessed via questionnaire.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2015 (estimated)
- Study startApr 2014
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Safe SexStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,017 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innovation Research & Training
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Tracy M Scull, PhD, Principal investigator, Innovation Research & Training
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02359422
- Sponsor's protocol ID
- iRT-2R44HD061193-02-RCT
- Other IDs
- 2R44HD061193-02
- Acronym
- MASH
- Status last verified
- Nov 2015
- First submitted
- 3 Sep 2014
- Last updated
- 20 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Scull TM, Kupersmidt JB, Malik CV, Morgan-Lopez AA. Using Media Literacy Education for Adolescent Sexual Health Promotion in Middle School: Randomized Control Trial of Media Aware. J Health Commun. 2018;23(12):1051-1063. doi: 10.1080/10810730.2018.1548669. Epub 2018 Nov 23.
PubMed 30468408
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Control Trial Efficacy Study of a Comprehensive Sexual Health Media Literacy Education Program for Middle School Students
- ClinicalTrials.gov ID
- NCT02359422
- Acronym / sponsor ID
- MASH / iRT-2R44HD061193-02-RCT
- Conditions
- Safe Sex
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,017 participants (actual)
- Lead sponsor
- Innovation Research & TrainingUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Apr 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 10 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Media Aware-Sexual Health | Experimental | Behavioral: Media Aware-Sexual Health10-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. |
| Wait-list control | No intervention | – |
Who may qualify
- Ages
- 10 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Must be able to read and write in English
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Media Aware-Sexual Health10-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. | Behavioural | Media Aware-Sexual Health |
Primary outcome
Change in self-reported sexual activity assessed via questionnaire.
Time frame: 2 weeks
Change in self-reported sexual activity assessed via questionnaire.
Time frame: 3 months
24 secondary outcomes
Change in self-reported intentions to engage in sexual activity assessed via questionnaire.
Time frame: 2 weeks
Change in self-reported intentions to engage in sexual activity assessed via questionnaire.
Time frame: 3 months
Change in self-reported attitude toward sexual activity assessed via questionnaire.
Time frame: 2 weeks
Change in self-reported attitude toward sexual activity assessed via questionnaire.
Time frame: 3 months
Change in self-reported attitudes toward contraception assessed via questionnaire.
Time frame: 2 weeks
Change in self-reported attitudes toward contraception assessed via questionnaire.
Time frame: 3 months
Change in self-reported attitude toward sexual communication assessed via questionnaire.
Time frame: 2 weeks
Change in self-reported attitude toward sexual communication assessed via questionnaire.
Time frame: 3 months
Change in self-reported perceived norms regarding sexual activity assessed via questionnaire.
Time frame: 2 weeks
Change in self-reported perceived norms regarding sexual activity assessed via questionnaire.
Time frame: 3 months
Change in self-reported perceived norms regarding contraception assessed via questionnaire.
Time frame: 2 weeks
Change in self-reported perceived norms regarding contraception assessed via questionnaire.
Time frame: 3 months
Change in self-reported perceived norms regarding sexual communication assessed via questionnaire.
Time frame: 2 weeks
Change in self-reported perceived norms regarding sexual communication assessed via questionnaire.
Time frame: 3 months
Change in self-reported self-efficacy to refusal sexual activity assessed via questionnaire.
Time frame: 2 weeks
Change in self-reported self-efficacy to refusal sexual activity assessed via questionnaire.
Time frame: 3 months
Change in self-reported self-efficacy to use contraception assessed via questionnaire.
Time frame: 2 weeks
Change in self-reported self-efficacy to use contraception assessed via questionnaire.
Time frame: 3 months
Change in self-reported self-efficacy for sexual communication assessed via questionnaire.
Time frame: 2 weeks
Change in self-reported self-efficacy for sexual communication assessed via questionnaire.
Time frame: 3 months
Change in self-reported intentions for condom/contraception use assessed via questionnaire.
Time frame: 2 weeks
Change in self-reported intentions for condom/contraception use assessed via questionnaire.
Time frame: 3 months
Change in self-reported intentions for sexual communication assessed via questionnaire.
Time frame: 2 weeks
Change in self-reported intentions for sexual communication assessed via questionnaire.
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2015.
- Derived from this study: PubMed 30468408Scull TM, Kupersmidt JB, Malik CV, Morgan-Lopez AA. Using Media Literacy Education for Adolescent Sexual Health Promotion in Middle School: Randomized Control Trial of Media Aware. J Health Commun. 2018;23(12):1051-1063. doi: 10.1080/10810730.2018.1548669. Epub 2018 Nov 23.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tracy M Scull, PhD principal investigator
Innovation Research & Training
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Media Aware-Sexual Health in people with Safe Sex, run by Innovation Research & Training at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in self-reported sexual activity assessed via questionnaire. (time frame: 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02359422, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2015.