Sexual BehaviorFS-OHSMAPNCT03855033
Feasibility Study of the Online High School Media Aware Program
A study testing Media Aware Sexual Health - High School in people with Sexual Behavior, run by Innovation Research & Training at 1 site in United States.
Trial summary
This is a pretest-posttest feasibility study of Media Aware Sexual Health - High School, an interactive web-based comprehensive sexual health media literacy education program for high school students. The program is designed to develop students' critical thinking skills and promote sexual health. Read more about this study
- Who is it for?
- Ages 12 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Sexual Behavior
- What is being tested?
- Media Aware Sexual Health - High School
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 367 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jan 2018to 12 Mar 2018
- 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 12 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Students must be in grades 9 or 10 in participating classrooms at participating schools.
- Students must be able to speak and read English because the study materials (e.g., questionnaires) and the program are in English.
- Students must have appropriate permissions to receive sex education per school districts' policy (i.e., opt-in policy or opt-out policy).
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
innovation Research & Training
Durham, North Carolina, 27707
About this study
Official title: Web-based High School Media Literacy for Healthy Relationships,
This is a pretest-posttest feasibility study of Media Aware Sexual Health - High School, an interactive web-based comprehensive sexual health media literacy education program for high school students. The program is designed to develop students' critical thinking skills and promote sexual health. It is hypothesized that this program will enhance adolescents' media literacy skills, sexual health knowledge, cognitions (i.e., attitudes, self-efficacy, and norms), and behaviors regarding healthy sexual decision-making.
- Conditions
- Sexual Behavior
- Being tested
- Media Aware Sexual Health - High School
- Medical subject headings
- Sexual Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Media Aware Sexual Health - High SchoolBehavioural
Also called Media Aware
Media Aware Sexual Health is a web-based comprehensive sexual health education program for high school students that uses a media literacy approach.
| Study group | Role | What they receive |
|---|---|---|
| Media Aware Sexual Health - High School | Experimental | Students received the web-based Media Aware Sexual Health - High School program. Receives: Behavioral: Media Aware Sexual Health - High School |
| Typical Health Education Programming | No intervention | Students received their regular health education programming not related to sexual health education. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in willingness to engage in unprotected sex
4-point Likert scale (strongly disagree; disagree; agree; strongly agree) assessing the degree to which one is willing to engage in unprotected sex (Suppose you were with a boyfriend/girlfriend. He/she wants to have sex, but neither of you have any form of protection. In this situation, how willing would you be to go ahead and hook-up anyway?).
Measured: pretest and posttest (approximately one week after pretest)
Change in willingness to hook up against own wishes
4-point Likert scale (strongly disagree; disagree; agree; strongly agree) assessing the degree to which one is willing to hook up with someone even if they are not sure that they really want to. (Suppose you were with a boyfriend/girlfriend. He/she wants to hook-up, but you are not sure that you want to. In this situation, how willing would you be to go ahead and hook-up anyway?).
Measured: pretest and posttest (approximately one week after pretest)
Change in intentions to use contraception/protection
4-point Likert scale (not at all likely; unlikely; likely; extremely likely) assessing intentions to use contraception (e.g., if you were to have vaginal or anal sex, how likely would you be to use a condom?).
Measured: pretest and posttest (approximately one week after pretest)
Change in intentions to engage in sexual activity
4-point Likert scale (not at all likely; unlikely; likely; extremely likely) assessing participants intentions to engage in sex in the next year (How likely is that you will have any type of sexual contact with another person (oral sex, anal sex, vaginal sex, or genital-to-genital contact) in the next year?).
Measured: pretest and posttest (approximately one week after pretest)
Secondary outcomes (15)
Efficacy to refuse sexual activity
4-point Likert scale (strongly disagree; disagree; agree; strongly agree) assessing participants efficacy to refuse sex (e.g., I could say no to someone who is pressuring me to have sex).
Measured: pretest and posttest (approximately one week after pretest)
Efficacy to communicate before sex
4-point Likert scale (strongly disagree; disagree; agree; strongly agree) assessing participants efficacy to communicate about sexual health (e.g., I could talk with a boy/girlfriend about using condoms for sexually transmitted infection protection).
Measured: pretest and posttest (approximately one week after pretest)
Efficacy to use contraception/protection
4-point Likert scale (strongly disagree; disagree; agree; strongly agree) assessing participants efficacy to get and use contraception (e.g., If I wanted to, I could get condoms or another form of contraception).
Measured: pretest and posttest (approximately one week after pretest)
Intentions to communicate before sex
4-point Likert scale (not at all likely; unlikely; likely; extremely likely) assessing intentions to communicate about sexual health before sex (e.g., Before deciding to have sex, how likely would you be to talk to a boy/girlfriend about HIV/AIDS or other sexually transmitted infections?).
Measured: pretest and posttest (approximately one week after pretest)
Sexual health knowledge
Participants are asked several multiple choice and T/F questions about sexual health.
Measured: pretest and posttest (approximately one week after pretest)
Norms - Frequency of teen risky sexual activity (%)
Participants are asked to indicate what percentage [0% = no teens; 100% = all teens] are engage in risky sexual activities (e.g., have sex with someone who is much older).
Measured: pretest and posttest (approximately one week after pretest)
Norms - teen sexual activity (%)
Participants are asked to indicate what percentage [0% = no teens; 100% = all teens] are engage in sexual activity.
Measured: pretest and posttest (approximately one week after pretest)
Perceived realism of media messages
Participants are asked on a 4-point Likert scale (strongly disagree; disagree; agree; strongly agree) the degree to which they agreed that teens on the media: 1) do things that average teens do; 2) act like average teens; 3) are as sexually experienced as average teens; 3) get pregnant as often as average teens; 4) get STIs as often as average teens.
Measured: pretest and posttest (approximately one week after pretest)
Perceived similarity to media messages
Participants are asked on a 4-point Likert scale (strongly disagree; disagree; agree; strongly agree) the degree to which they agreed that: 1) The things I do in my life are similar to what I see teens do in the media; 2) I look like teens I see in the media; 3) I like the kinds of things that teens in the media like.
Measured: pretest and posttest (approximately one week after pretest)
Cognitive elaboration of advertisement
Participants are shown an advertisement and responded on a 4-point Likert scale (not much at all; a little; a good amount; a lot) the extent to which they: 1) thought about the ad; 2) spent time thinking about the ad; and 3) paid attention to the ad.
Measured: pretest and posttest (approximately one week after pretest)
Media Skepticism
Participants are asked on a 4-point Likert scale (strongly disagree; disagree; agree; strongly agree) the degree to which they agree with several statements about media (e.g., Media are dishonest about what happens when people drink alcohol).
Measured: pretest and posttest (approximately one week after pretest)
Teen Sex Attitudes
Participants are asked on a 4-point Likert scale (strongly disagree; disagree; agree; strongly agree) the degree to which they agree with several statements about teen sex (e.g., it is ok for teens to be sexually active).
Measured: pretest and posttest (approximately one week after pretest)
Risky Teen Sex Attitudes
Participants are asked on a 4-point Likert scale (strongly disagree; disagree; agree; strongly agree) the degree to which they agree with several statements about teens engaging in risky sexually behaviors (e.g., I believe it is ok for teens to do use alcohol or drugs before or during a sexual encounter.)
Measured: pretest and posttest (approximately one week after pretest)
Teen Contraception Use Attitudes
Participants are asked on a 4-point Likert scale (strongly disagree; disagree; agree; strongly agree) the degree to which they agree with several statements about teen contraception use (e.g., I believe if a teen is going to have sex, they should always use a condom.)
Measured: pretest and posttest (approximately one week after pretest)
Teen Sexual Communication Attitudes
Participants are asked on a 4-point Likert scale (strongly disagree; disagree; agree; strongly agree) the degree to which they agree with several statements about teen sexual communication (e.g., Before deciding to have sex, I believe teens should talk with their parents or another trusted adult).
Measured: pretest and posttest (approximately one week after pretest)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2019
- Study start24 Jan 2018
- Primary completion12 Mar 2018
- Study completion12 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexual BehaviorStudies 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
- 367 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innovation Research & Training
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03855033
- Sponsor's protocol ID
- iRT-Media Aware HS-Phase I
- Acronym
- FS-OHSMAP
- Status last verified
- Feb 2019
- First submitted
- 21 Feb 2019
- Last updated
- 26 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Web-based High School Media Literacy for Healthy Relationships,
- ClinicalTrials.gov ID
- NCT03855033
- Acronym / sponsor ID
- FS-OHSMAP / iRT-Media Aware HS-Phase I
- Conditions
- Sexual Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 367 participants (actual)
- Lead sponsor
- Innovation Research & TrainingUniversity, hospital or other
- Study start
- 24 Jan 2018 (actual)
- Primary completion
- 12 Mar 2018 (actual)
- Study completion
- 12 Mar 2018 (actual)
- First posted
- 26 Feb 2019 (actual)
- 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.
This is a pretest-posttest feasibility study of Media Aware Sexual Health - High School, an interactive web-based comprehensive sexual health media literacy education program for high school students. The program is designed to develop students' critical thinking skills and promote sexual health. It is hypothesized that this program will enhance adolescents' media literacy skills, sexual health knowledge, cognitions (i.e., attitudes, self-efficacy, and norms), and behaviors regarding healthy sexual decision-making.
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 - High School | Experimental | Behavioral: Media Aware Sexual Health - High SchoolStudents received the web-based Media Aware Sexual Health - High School program. |
| Typical Health Education Programming | No intervention | –Students received their regular health education programming not related to sexual health education. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Students must be in grades 9 or 10 in participating classrooms at participating schools.
- Students must be able to speak and read English because the study materials (e.g., questionnaires) and the program are in English.
- Students must have appropriate permissions to receive sex education per school districts' policy (i.e., opt-in policy or opt-out policy).
Key exclusion criteria (0 listed)
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 Health - High SchoolAlso: Media AwareMedia Aware Sexual Health is a web-based comprehensive sexual health education program for high school students that uses a media literacy approach. | Behavioural | Media Aware Sexual Health - High School |
Primary outcome
Change in willingness to engage in unprotected sex
Time frame: pretest and posttest (approximately one week after pretest)
4-point Likert scale (strongly disagree; disagree; agree; strongly agree) assessing the degree to which one is willing to engage in unprotected sex (Suppose you were with a boyfriend/girlfriend. He/she wants to have sex, but neither of you have any form of protection. In this situation, how willing would you be to go ahead and hook-up anyway?).
Change in willingness to hook up against own wishes
Time frame: pretest and posttest (approximately one week after pretest)
4-point Likert scale (strongly disagree; disagree; agree; strongly agree) assessing the degree to which one is willing to hook up with someone even if they are not sure that they really want to. (Suppose you were with a boyfriend/girlfriend. He/she wants to hook-up, but you are not sure that you want to. In this situation, how willing would you be to go ahead and hook-up anyway?).
Change in intentions to use contraception/protection
Time frame: pretest and posttest (approximately one week after pretest)
4-point Likert scale (not at all likely; unlikely; likely; extremely likely) assessing intentions to use contraception (e.g., if you were to have vaginal or anal sex, how likely would you be to use a condom?).
Change in intentions to engage in sexual activity
Time frame: pretest and posttest (approximately one week after pretest)
4-point Likert scale (not at all likely; unlikely; likely; extremely likely) assessing participants intentions to engage in sex in the next year (How likely is that you will have any type of sexual contact with another person (oral sex, anal sex, vaginal sex, or genital-to-genital contact) in the next year?).
15 secondary outcomes
Efficacy to refuse sexual activity
Time frame: pretest and posttest (approximately one week after pretest)
Efficacy to communicate before sex
Time frame: pretest and posttest (approximately one week after pretest)
Efficacy to use contraception/protection
Time frame: pretest and posttest (approximately one week after pretest)
Intentions to communicate before sex
Time frame: pretest and posttest (approximately one week after pretest)
Sexual health knowledge
Time frame: pretest and posttest (approximately one week after pretest)
Norms - Frequency of teen risky sexual activity (%)
Time frame: pretest and posttest (approximately one week after pretest)
Norms - teen sexual activity (%)
Time frame: pretest and posttest (approximately one week after pretest)
Perceived realism of media messages
Time frame: pretest and posttest (approximately one week after pretest)
Perceived similarity to media messages
Time frame: pretest and posttest (approximately one week after pretest)
Cognitive elaboration of advertisement
Time frame: pretest and posttest (approximately one week after pretest)
Media Skepticism
Time frame: pretest and posttest (approximately one week after pretest)
Teen Sex Attitudes
Time frame: pretest and posttest (approximately one week after pretest)
Risky Teen Sex Attitudes
Time frame: pretest and posttest (approximately one week after pretest)
Teen Contraception Use Attitudes
Time frame: pretest and posttest (approximately one week after pretest)
Teen Sexual Communication Attitudes
Time frame: pretest and posttest (approximately one week after pretest)
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 26 Feb 2019.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 - High School in people with Sexual Behavior, 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 3 inclusion and 0 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 26 Feb 2019. 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 willingness to engage in unprotected sex (time frame: pretest and posttest (approximately one week after pretest)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Feb 2019.