Sexual BehaviorNCT04035694
Evaluation 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
The main aim of this study is to conduct a pretest-posttest RCT with a three-month follow-up to investigate the sustainability of outcomes in students who use the Media Aware program. Media Aware, a web-based media literacy education program for high school students to promote sexual and relationship 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 590 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Sep 2019to 5 Jun 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Schools must have students in 9th or 10th grade health education as this program is designed for use in these grades during health education classes.
- Schools must agree to provide the Media Aware program during class periods as their sexual health education which means that an educator will facilitate the students taking the program.
- Schools must have adequate technology for the students to use the web-based Media Aware program and complete the online questionnaires.
- It must be feasible for iRT project staff members to travel to the school sites for the three data collection time points.
- TEACHER PARTICIPANTS:
- Teacher's classrooms must have students in 9th or 10th grade as this program is designed for use in these grades.
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- Teachers must be able to ensure that participating students have computers and internet access during class periods as the program and questionnaires are web-based.
- STUDENT PARTICIPANTS:
- Students must be in grades 9 or 10.
- Students must be able to speak and read English because the study materials (e.g., questionnaires) are in English. However, parent permission and youth assent forms for the research study will be available in both English and Spanish.
- Students must have appropriate parent permission to receive sexual health 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 and Training
Durham, North Carolina, 27713
About this study
Official title: Web-based High School Media Literacy for Healthy Relationships
The main aim of this study is to conduct a pretest-posttest RCT with a three-month follow-up to investigate the sustainability of outcomes in students who use the Media Aware program. Media Aware, a web-based media literacy education program for high school students to promote sexual and relationship health. Media Aware is designed to provide high school students with sexual health knowledge, media literacy skills, and the skills to make healthy decisions about sexual activity. This study will examine if behavioral indicators among students in the intervention group sustain, emerge, or diminish over time compared to students in the delayed intervention group.
- Conditions
- Sexual Behavior
- Being tested
- Media Aware Sexual Health - High School
- Keywords
- Adolescent sexual health, Media literacy education, Web-based programming
- 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 SchoolOther
Also called Media Aware
Media Aware is an online media literacy and sexual health education program developed for high school students that addresses the influence of media on sexual behaviors explicitly using established message processing theory. The program consists of 4 self-paced modules each with two to three lessons. Broadly, the modules cover healthy and unhealthy relationships, sexually transmitted infections, consent, substance use, pregnancy, protection and contraception, and communication between adolescents and their partners, parents, or health providers. Users also learn media literacy skills including message deconstruction to help examine the truth behind media messages.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participants will receive access to Media Aware. Receives: Other: Media Aware Sexual Health - High School |
| Delayed-Intervention Control | No intervention | Participants will receive their regular health education programming not related to sexual health education or media literacy education. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Willingness to Have Sex
Participants are asked to indicate on a 4-point Likert scale (1=very unwilling; 2=unwilling; 3=willing; 4=very willing) how willing they are to have sex in a relationship context. (Imagine you were with a boyfriend/girlfriend and they say they love you. They want to have sex. In this situation, how willing would you be to have sex?).
Measured: posttest (approximately one week after pretest)
Willingness to Have Sex
Participants are asked to indicate on a 4-point Likert scale (1=very unwilling; 2=unwilling; 3=willing; 4=very willing) how willing they are to have sex in a relationship context. (Imagine you were with a boyfriend/girlfriend and they say they love you. They want to have sex. In this situation, how willing would you be to have sex?).
Measured: follow-up (approximately three months after pretest)
Willingness to Engage in Unprotected Sex
Participants are asked to indicate on a 4-point Likert scale (1=very unwilling; 2=unwilling; 3=willing; 4=very willing) how willing they are to engage in unprotected sex (Imagine you were with a boyfriend/girlfriend. They want to have sex, but neither of you have any form of protection. In this situation, how willing would you be to go ahead and have sex anyway?). (adapted from Gibbons, Gerrard, Blanton, \& Russell, 2014)
Measured: posttest (approximately one week after pretest)
Willingness to Engage in Unprotected Sex
Participants are asked to indicate on a 4-point Likert scale (1=very unwilling; 2=unwilling; 3=willing; 4=very willing) how willing they are to engage in unprotected sex (Imagine you were with a boyfriend/girlfriend. They want to have sex, but neither of you have any form of protection. In this situation, how willing would you be to go ahead and have sex anyway?). (adapted from Gibbons, Gerrard, Blanton, \& Russell, 2014)
Measured: follow-up (approximately three months after pretest)
Willingness to Hook up
Participants are asked to indicate on a 4-point Likert scale (1=very unwilling; 2=unwilling; 3=willing; 4=very willing) how willing they are to have hook up even if they are not sure that they really want to (Imagine you were with a boyfriend/girlfriend. They want 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?). (adapted from Gibbons, Gerrard, Blanton, \& Russell, 2014)
Measured: posttest (approximately one week after pretest)
Willingness to Hook up
Participants are asked to indicate on a 4-point Likert scale (1=very unwilling; 2=unwilling; 3=willing; 4=very willing) how willing they are to have hook up even if they are not sure that they really want to (Imagine you were with a boyfriend/girlfriend. They want 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?). (adapted from Gibbons, Gerrard, Blanton, \& Russell, 2014)
Measured: follow-up (approximately three months after pretest)
Intentions to Engage in Sexual Activity With Another Person
Participants are asked to indicate on a 4-point Likert scale (1=not at all likely; 2=unlikely; 3=likely; 4=extremely likely) how likely they are to engage in sexual activity 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?). α = 0.77 (adapted from L'Engle, Brown, and Kenneavy, 2006)
Measured: posttest (approximately one week after pretest)
Intentions to Engage in Sexual Activity With Another Person
Participants are asked to indicate on a 4-point Likert scale (1=not at all likely; 2=unlikely; 3=likely; 4=extremely likely) how likely they are to engage in sexual activity 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?). α = 0.77 (adapted from L'Engle, Brown, and Kenneavy, 2006)
Measured: follow-up (approximately three months after pretest)
Condom Use Intentions
Participants are asked to indicate on a 4-point Likert scale (1=not at all likely; 2=unlikely; 3=likely; 4=extremely likely) how likely they are to use protection (if you were to have vaginal or anal sex, how likely would you be to use a condom?). (adapted from Jemmott and Jemmott, 1991)
Measured: posttest (approximately one week after pretest)
Condom Use Intentions
Participants are asked to indicate on a 4-point Likert scale (1=not at all likely; 2=unlikely; 3=likely; 4=extremely likely) how likely they are to use protection (if you were to have vaginal or anal sex, how likely would you be to use a condom?). (adapted from Jemmott and Jemmott, 1991)
Measured: follow-up (approximately three months after pretest)
Birth Control Use Intentions (Other Than Condoms)
Participants are asked to indicate on a 4-point Likert scale (1=not at all likely; 2=unlikely; 3=likely; 4=extremely likely) how likely they are to use protection (if you were to have vaginal sex, how likely would you be to use birth control other than condoms?). (adapted from Jemmott and Jemmott, 1991)
Measured: posttest (approximately one week after pretest)
Birth Control Use Intentions (Other Than Condoms)
Participants are asked to indicate on a 4-point Likert scale (1=not at all likely; 2=unlikely; 3=likely; 4=extremely likely) how likely they are to use protection (if you were to have vaginal sex, how likely would you be to use birth control other than condoms?). (adapted from Jemmott and Jemmott, 1991)
Measured: follow-up (approximately three months after pretest)
Protection Intentions During Oral Sex
Participants are asked to indicate on a 4-point Likert scale (1=not at all likely; 2=unlikely; 3=likely; 4=extremely likely) how likely they are to use protection (if you were to decide to have oral sex, how likely would you be to use a condom or dental dam?). (adapted from Jemmott and Jemmott, 1991)
Measured: posttest (approximately one week after pretest)
Protection Intentions During Oral Sex
Participants are asked to indicate on a 4-point Likert scale (1=not at all likely; 2=unlikely; 3=likely; 4=extremely likely) how likely they are to use protection (if you were to decide to have oral sex, how likely would you be to use a condom or dental dam?). (adapted from Jemmott and Jemmott, 1991)
Measured: follow-up (approximately three months after pretest)
Secondary outcomes (44)
Perceived Realism of Media Messages
Participants are asked to indicate on a 4-point Likert scale (1=strongly disagree; 2=disagree; 3=agree; 4=strongly agree) the degree to which they agreed that teens on the media (e.g., Teens in the media do things that average teens do.). (adapted from Austin and Johnson, 1997, α=0.80)
Measured: posttest (approximately one week after pretest)
Perceived Realism of Media Messages
Participants are asked to indicate on a 4-point Likert scale (1=strongly disagree; 2=disagree; 3=agree; 4=strongly agree) the degree to which they agreed that teens on the media (e.g., Teens in the media do things that average teens do.). (adapted from Austin and Johnson, 1997, α=0.80)
Measured: follow-up (approximately three months after pretest)
Acceptance of Dating Violence
Participants are asked to indicate on a 4-point Likert scale (1=strongly 2=disagree; 3=disagree; 4=agree; strongly agree) their level of agreement on several items pertaining to dating violence (e.g., It is okay for people to hit their girlfriends/boyfriends if they did something to make them mad.). (adapted from Foshee, Bauman, Ennett, Suchindran, Benefield, and Linder, 2005 α=0.73)
Measured: posttest (approximately one week after pretest)
Acceptance of Dating Violence
Participants are asked to indicate on a 4-point Likert scale (1=strongly 2=disagree; 3=disagree; 4=agree; strongly agree) their level of agreement on several items pertaining to dating violence (e.g., It is okay for people to hit their girlfriends/boyfriends if they did something to make them mad.). (adapted from Foshee, Bauman, Ennett, Suchindran, Benefield, and Linder, 2005 α=0.73)
Measured: follow-up (approximately three months after pretest)
Advertisement Deconstruction Skills
Participants are shown an advertisement and asked to describe it in detail including noting marketing strategies and any missing information (e.g., How are advertisers trying to get someone to buy this product?). Qualitative responses to the questions are coded by trained project staff members once inter-coder reliability is established, and scores will be summed to create an overall deconstruction skills composite variable. (adapted from Kupersmidt, Scull, \& Benson, 2012)
Measured: posttest (approximately one week after pretest)
Advertisement Deconstruction Skills
Participants are shown an advertisement and asked to describe it in detail including noting marketing strategies and any missing information (e.g., How are advertisers trying to get someone to buy this product?). Qualitative responses to the questions are coded by trained project staff members once inter-coder reliability is established, and scores will be summed to create an overall deconstruction skills composite variable (adapted from Kupersmidt, Scull, \& Benson, 2012).
Measured: follow-up (approximately three months after pretest)
Media Message Completeness
Participants are shown an advertisement and asked to indicate on a 4-point Likert scale (1=incomplete to 4=complete) how complete the information included in an advertisement is (e.g., How complete is the information in this advertisement?).
Measured: posttest (approximately one week after pretest)
Media Message Completeness
Participants are shown an advertisement and asked to indicate on a 4-point Likert scale (1=incomplete to 4=complete) how complete the information included in an advertisement is (e.g., How complete is the information in this advertisement?).
Measured: follow-up (approximately three months after pretest)
Media Skepticism
Participants are asked to indicate on a 4-point Likert scale (1=strongly disagree; 2=disagree; 3=agree; 4=strongly agree) the degree to which they agree with several statements about media (e.g., Media are dishonest about what happens if people have sex.). (adapted from Scull, Malik, and Kupersmidt, 2014, α=0.86)
Measured: posttest (approximately one week after pretest)
Media Skepticism
Participants are asked to indicate on a 4-point Likert scale (1=strongly disagree; 2=disagree; 3=agree; 4=strongly agree) the degree to which they agree with several statements about media (e.g., Media are dishonest about what happens if people have sex.). (adapted from Scull, Malik, and Kupersmidt, 2014, α=0.86)
Measured: follow-up (approximately three months after pretest)
Acceptance of Strict Gender Role Stereotypes
Participants are asked to indicate on a 4-point Likert scale (1=strongly disagree; 2=disagree; 3=agree; 4=strongly agree) their level of agreement on several items pertaining to strict gender role stereotypes (e.g., Raising children is primarily a woman's responsibility.). (adapted from Foshee, Bauman, Ennett, Suchindran, Benefield, and Linder, 2005 α=0.87)
Measured: posttest (approximately one week after pretest)
Acceptance of Strict Gender Role Stereotypes
Participants are asked to indicate on a 4-point Likert scale (1=strongly disagree; 2=disagree; 3=agree; 4=strongly agree) their level of agreement on several items pertaining to strict gender role stereotypes (e.g., Raising children is primarily a woman's responsibility.). (adapted from Foshee, Bauman, Ennett, Suchindran, Benefield, and Linder, 2005 α=0.87)
Measured: follow-up (approximately three months after pretest)
Acceptance of Rape Myths
Participants are asked to indicate on a 4-point Likert scale (1=strongly disagree; 2=disagree; 3=agree; 4=strongly agree) their level of agreement on several items pertaining to myths about rape (e.g., It shouldn't be considered rape if a guy is drunk and didn't realize what he was doing.). (adapted from Illinois Rape Myth Acceptance-Short Form (IRMA-SF; 7 pt. scale); Payne et al., (1999); McMahon \& Farmer (2011), α=0.88)
Measured: posttest (approximately one week after pretest)
Acceptance of Rape Myths
Participants are asked to indicate on a 4-point Likert scale (1=strongly disagree; 2=disagree; 3=agree; 4=strongly agree) their level of agreement on several items pertaining to myths about rape (e.g., It shouldn't be considered rape if a guy is drunk and didn't realize what he was doing.). (adapted from Illinois Rape Myth Acceptance-Short Form (IRMA-SF; 7 pt. scale); Payne et al., (1999); McMahon \& Farmer (2011), α=0.88)
Measured: follow-up (approximately three months after pretest)
Intentions to Intervene as Bystander
Participants are asked to indicate on a 4-point Likert scale (1=not likely at all; 2=Unlikely; 3=Likely; 4=Extremely likely) how likely they would be to intervene as a bystander (e.g., Approach a friend if I thought they were in an abusive relationship and let them know that I am here to help.). (adapted from Banyard, 2005)
Measured: posttest (approximately one week after pretest)
Intentions to Intervene as Bystander
Participants are asked to indicate on a 4-point Likert scale (1=not likely at all; 2=Unlikely; 3=Likely; 4=Extremely likely) how likely they would be to intervene as a bystander (e.g., Approach a friend if I thought they were in an abusive relationship and let them know that I am here to help.). (adapted from Banyard, 2005)
Measured: follow-up (approximately three months after pretest)
Efficacy to Intervene as Bystander
Participants are asked to indicate on a scale of 0 (Can't do) to 100 (Very Certain) their degree of confidence in several behaviors (e.g., I could talk to a friend who I suspected is in an abusive relationship.). (adapted from Banyard, 2005)
Measured: posttest (approximately one week after pretest)
Efficacy to Intervene as Bystander
Participants are asked to indicate on a scale of 0 (Can't do) to 100 (Very Certain) their degree of confidence in several behaviors (e.g., I could talk to a friend who I suspected is in an abusive relationship.). (adapted from Banyard, 2005)
Measured: follow-up (approximately three months after pretest)
Descriptive Norms Regarding Teen Sexual Activity
Participants are asked to indicate what percentage [0% = no teens; 100% = all teens] of teens engage in sexual activity (e.g., oral sex, vaginal sex, anal sex). (adapted from Scull, Kupersmidt, Malik, and Keefe, 2018)
Measured: posttest (approximately one week after pretest)
Descriptive Norms Regarding Teen Sexual Activity
Participants are asked to indicate what percentage [0% = no teens; 100% = all teens] of teens engage in sexual activity (e.g., oral sex, vaginal sex, anal sex). (adapted from Scull, Kupersmidt, Malik, and Keefe, 2018)
Measured: follow-up (approximately three months after pretest)
Descriptive Norms Regarding Teen Risky Sexual Activity
Participants are asked to indicate what percentage [0% = no teens; 100% = all teens] of teens engage in risky sexual activities (e.g., What percentage of teens have sex with someone who is much older?). (adapted from Scull, Kupersmidt, Malik, and Keefe, 2018)
Measured: posttest (approximately one week after pretest)
Descriptive Norms Regarding Teen Risky Sexual Activity
Participants are asked to indicate what percentage [0% = no teens; 100% = all teens] of teens engage in risky sexual activities (e.g., What percentage of teens have sex with someone who is much older?). (adapted from Scull, Kupersmidt, Malik, and Keefe, 2018)
Measured: follow-up (approximately three months after pretest)
Sexual Health Knowledge
Participants are asked several multiple choice and True/False questions about sexual health (e.g., True or false: You can tell someone has an STI by looking at him/her.).
Measured: posttest (approximately one week after pretest)
Sexual Health Knowledge
Participants are asked several multiple choice and True/False questions about sexual health (e.g., True or false: You can tell someone has an STI by looking at him/her.).
Measured: follow-up (approximately three months after pretest)
Descriptive Norms Regarding Sexual Health Communication
Participants are asked to indicate what percentage [0% = no teens; 100% = all teens] of teens communicate with parents, health providers, or another trusted adult (e.g., Before deciding to have sex, what percentage of teens talk with their boy/girlfriend about sexual health?). (adapted from Scull, Kupersmidt, Malik, and Keefe, 2018)
Measured: posttest (approximately one week after pretest)
Descriptive Norms Regarding Sexual Health Communication
Participants are asked to indicate what percentage [0% = no teens; 100% = all teens] of teens communicate with parents, health providers, or another trusted adult (e.g., Before deciding to have sex, what percentage of teens talk with their boy/girlfriend about sexual health?). (adapted from Scull, Kupersmidt, Malik, and Keefe, 2018)
Measured: follow-up (approximately three months after pretest)
Efficacy to Negotiate Contraception/Protection Use
Participants are asked to indicate on a 4-point Likert scale (1=strongly disagree; 2=disagree; 3=agree; 4=strongly agree) how effectively they could convince a partner to use contraception (e.g., If I decided to have sex, I could talk to any potential partner to make him/her understand why we should use condoms or other contraception.).
Measured: posttest (approximately one week after pretest)
Efficacy to Negotiate Contraception/Protection Use
Participants are asked to indicate on a 4-point Likert scale (1=strongly disagree; 2=disagree; 3=agree; 4=strongly agree) how effectively they could convince a partner to use contraception (e.g., If I decided to have sex, I could talk to any potential partner to make him/her understand why we should use condoms or other contraception.).
Measured: follow-up (approximately three months after pretest)
Efficacy to Use Contraception/Protection
Participants are asked to indicate on a 4-point Likert scale (1=strongly disagree; 2=disagree; 3=agree; 4=strongly agree) how effectively they could get and use contraception (e.g., If I wanted to, I could get condoms or another form of contraception.).
Measured: posttest (approximately one week after pretest)
Efficacy to Use Contraception/Protection
Participants are asked to indicate on a 4-point Likert scale (1=strongly disagree; 2=disagree; 3=agree; 4=strongly agree) how effectively they could get and use contraception (e.g., If I wanted to, I could get condoms or another form of contraception.).
Measured: follow-up (approximately three months after pretest)
Descriptive Norms Regarding Teen Birth Control Use
Participants are asked to indicate what percentage [0% = no teens; 100% = all teens] of teens use contraception (e.g., What percentage of teens who have oral sex use a condom or a dental dam?). (adapted from Scull, Kupersmidt, Malik, and Keefe, 2018)
Measured: posttest (approximately one week after pretest)
Descriptive Norms Regarding Teen Birth Control Use
Participants are asked to indicate what percentage [0% = no teens; 100% = all teens] of teens use contraception (e.g., What percentage of teens who have oral sex use a condom or a dental dam?). (adapted from Scull, Kupersmidt, Malik, and Keefe, 2018)
Measured: follow-up (approximately three months after pretest)
Efficacy to Communicate Before Sex
Participants are asked to indicate on a 4-point Likert scale (1=strongly disagree; 2=disagree; 3=agree; 4=strongly agree) how effectively they could communicate with others about sexual health (e.g., I could talk with a boy/girlfriend about using condoms for sexually transmitted infection protection.). (adapted from Scull, Malik, \& Kupersmidt, 2014)
Measured: posttest (approximately one week after pretest)
Efficacy to Communicate Before Sex
Participants are asked to indicate on a 4-point Likert scale (1=strongly disagree; 2=disagree; 3=agree; 4=strongly agree) how effectively they could communicate with others about sexual health (e.g., I could talk with a boy/girlfriend about using condoms for sexually transmitted infection protection.). (adapted from Scull, Malik, \& Kupersmidt, 2014)
Measured: follow-up (approximately three months after pretest)
Intent to Communicate Before Sex
Participants are asked to indicate on a 4-point Likert scale (1=not at all likely; 2=unlikely; 3=likely; 4=extremely likely) how likely they are to communicate with others before sexual activity (e.g., Before deciding to have sex, how likely would you be to talk with your parents or another trusted adult about sexual health?). (adapted from Scull, Malik, \& Kupersmidt, 2014)
Measured: posttest (approximately one week after pretest)
Intent to Communicate Before Sex
Participants are asked to indicate on a 4-point Likert scale (1=not at all likely; 2=unlikely; 3=likely; 4=extremely likely) how likely they are to communicate with others before sexual activity (e.g., Before deciding to have sex, how likely would you be to talk with your parents or another trusted adult about sexual health?). (adapted from Scull, Malik, \& Kupersmidt, 2014)
Measured: follow-up (approximately three months after pretest)
Cognitive Elaboration While Viewing an Advertisement
Participants are shown an advertisement and asked to indicate on a 4-point Likert scale (1=not much at all; 2=a little; 3=a good amount; 4=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. (adapted from Shiv, Britton, and Payne, 2004)
Measured: posttest (approximately one week after pretest)
Cognitive Elaboration While Viewing an Advertisement
Participants are shown an advertisement and asked to indicate on a 4-point Likert scale (1=not much at all; 2=a little; 3=a good amount; 4=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. (adapted from Shiv, Britton, and Payne, 2004)
Measured: follow-up (approximately three months after pretest)
Communication With a Doctor or Other Health Professional About Sexual Health
Participants are asked on a 4-point Likert scale (1never; 2=rarely; 3=sometimes; 4=often) about their frequency of sexual health communication with a doctor or other health professional (e.g., How often do you talk with a doctor or other health professional about sexual health?).
Measured: posttest (approximately one week after pretest)
Communication With a Doctor or Other Health Professional About Sexual Health
Participants are asked on a 4-point Likert scale (1never; 2=rarely; 3=sometimes; 4=often) about their frequency of sexual health communication with a doctor or other health professional (e.g., How often do you talk with a doctor or other health professional about sexual health?).
Measured: follow-up (approximately three months after pretest)
Communication With a Parent or Other Trusted Adult About Sexual Health
Participants are asked on a 4-point Likert scale (1never; 2=rarely; 3=sometimes; 4=often) about their frequency of sexual health communication with a doctor or trusted adult (e.g., How often do you talk with a parent or other trusted professional about sexual health?).
Measured: posttest (approximately one week after pretest)
Communication With a Parent or Other Trusted Adult About Sexual Health
Participants are asked on a 4-point Likert scale (1never; 2=rarely; 3=sometimes; 4=often) about their frequency of sexual health communication with a doctor or trusted adult (e.g., How often do you talk with a parent or other trusted professional about sexual health?).
Measured: follow-up (approximately three months after pretest)
Communication With a Boyfriend or Girlfriend About Sexual Health
Participants are asked on a 4-point Likert scale (1never; 2=rarely; 3=sometimes; 4=often) about their frequency of sexual health communication with a boyfriend/girlfriend (e.g., How often do you talk with your boyfriend/girlfriend about sexual health?).
Measured: posttest (approximately one week after pretest)
Communication With a Boyfriend or Girlfriend About Sexual Health
Participants are asked on a 4-point Likert scale (1never; 2=rarely; 3=sometimes; 4=often) about their frequency of sexual health communication with a boyfriend/girlfriend (e.g., How often do you talk with your boyfriend/girlfriend about sexual health?).
Measured: follow-up (approximately three months after pretest)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2019
- Study start10 Sep 2019
- Primary completion5 Jun 2020
- Study completion5 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 590 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
- NCT04035694
- Sponsor's protocol ID
- iRT-Media Aware HS-Phase II
- Status last verified
- Mar 2021
- First submitted
- 16 Jul 2019
- Last updated
- 28 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All data collected will only be used for the research purposes in accordance with protocols approved by the IRB.
Publications
Scull TM, Malik CV, Morrison A, Keefe EM. Study protocol for a randomized controlled trial to evaluate a web-based comprehensive sexual health and media literacy education program for high school students. Trials. 2020 Jan 8;21(1):50. doi: 10.1186/s13063-019-3992-1.
PubMed 31915060
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2021. 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
- NCT04035694
- Acronym / sponsor ID
- iRT-Media Aware HS-Phase II
- Conditions
- Sexual Behavior
- Keywords
- Adolescent sexual health, Media literacy education, Web-based programming
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 590 participants (actual)
- Lead sponsor
- Innovation Research & TrainingUniversity, hospital or other
- Study start
- 10 Sep 2019 (actual)
- Primary completion
- 5 Jun 2020 (actual)
- Study completion
- 5 Jun 2020 (actual)
- First posted
- 29 Jul 2019 (actual)
- Results
- Posted 28 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main aim of this study is to conduct a pretest-posttest RCT with a three-month follow-up to investigate the sustainability of outcomes in students who use the Media Aware program. Media Aware, a web-based media literacy education program for high school students to promote sexual and relationship health. Media Aware is designed to provide high school students with sexual health knowledge, media literacy skills, and the skills to make healthy decisions about sexual activity. This study will examine if behavioral indicators among students in the intervention group sustain, emerge, or diminish over time compared to students in the delayed intervention group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Media Aware Sexual Health - High SchoolParticipants will receive access to Media Aware. |
| Delayed-Intervention Control | No intervention | –Participants will receive their regular health education programming not related to sexual health education or media literacy education. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- Schools must have students in 9th or 10th grade health education as this program is designed for use in these grades during health education classes.
- Schools must agree to provide the Media Aware program during class periods as their sexual health education which means that an educator will facilitate the students taking the program.
- Schools must have adequate technology for the students to use the web-based Media Aware program and complete the online questionnaires.
- It must be feasible for iRT project staff members to travel to the school sites for the three data collection time points.
- Teacher's classrooms must have students in 9th or 10th grade as this program is designed for use in these grades.
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 is an online media literacy and sexual health education program developed for high school students that addresses the influence of media on sexual behaviors explicitly using established message processing theory. The program consists of 4 self-paced modules each with two to three lessons. Broadly, the modules cover healthy and unhealthy relationships, sexually transmitted infections, consent, substance use, pregnancy, protection and contraception, and communication between adolescents and their partners, parents, or health providers. Users also learn media literacy skills including message deconstruction to help examine the truth behind media messages. | Other | Intervention |
Primary outcome
Willingness to Have Sex
Time frame: posttest (approximately one week after pretest)
Participants are asked to indicate on a 4-point Likert scale (1=very unwilling; 2=unwilling; 3=willing; 4=very willing) how willing they are to have sex in a relationship context. (Imagine you were with a boyfriend/girlfriend and they say they love you. They want to have sex. In this situation, how willing would you be to have sex?).
Willingness to Have Sex
Time frame: follow-up (approximately three months after pretest)
Participants are asked to indicate on a 4-point Likert scale (1=very unwilling; 2=unwilling; 3=willing; 4=very willing) how willing they are to have sex in a relationship context. (Imagine you were with a boyfriend/girlfriend and they say they love you. They want to have sex. In this situation, how willing would you be to have sex?).
Willingness to Engage in Unprotected Sex
Time frame: posttest (approximately one week after pretest)
Participants are asked to indicate on a 4-point Likert scale (1=very unwilling; 2=unwilling; 3=willing; 4=very willing) how willing they are to engage in unprotected sex (Imagine you were with a boyfriend/girlfriend. They want to have sex, but neither of you have any form of protection. In this situation, how willing would you be to go ahead and have sex anyway?). (adapted from Gibbons, Gerrard, Blanton, \& Russell, 2014)
Willingness to Engage in Unprotected Sex
Time frame: follow-up (approximately three months after pretest)
Participants are asked to indicate on a 4-point Likert scale (1=very unwilling; 2=unwilling; 3=willing; 4=very willing) how willing they are to engage in unprotected sex (Imagine you were with a boyfriend/girlfriend. They want to have sex, but neither of you have any form of protection. In this situation, how willing would you be to go ahead and have sex anyway?). (adapted from Gibbons, Gerrard, Blanton, \& Russell, 2014)
Willingness to Hook up
Time frame: posttest (approximately one week after pretest)
Participants are asked to indicate on a 4-point Likert scale (1=very unwilling; 2=unwilling; 3=willing; 4=very willing) how willing they are to have hook up even if they are not sure that they really want to (Imagine you were with a boyfriend/girlfriend. They want 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?). (adapted from Gibbons, Gerrard, Blanton, \& Russell, 2014)
Willingness to Hook up
Time frame: follow-up (approximately three months after pretest)
Participants are asked to indicate on a 4-point Likert scale (1=very unwilling; 2=unwilling; 3=willing; 4=very willing) how willing they are to have hook up even if they are not sure that they really want to (Imagine you were with a boyfriend/girlfriend. They want 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?). (adapted from Gibbons, Gerrard, Blanton, \& Russell, 2014)
Intentions to Engage in Sexual Activity With Another Person
Time frame: posttest (approximately one week after pretest)
Participants are asked to indicate on a 4-point Likert scale (1=not at all likely; 2=unlikely; 3=likely; 4=extremely likely) how likely they are to engage in sexual activity 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?). α = 0.77 (adapted from L'Engle, Brown, and Kenneavy, 2006)
Intentions to Engage in Sexual Activity With Another Person
Time frame: follow-up (approximately three months after pretest)
Participants are asked to indicate on a 4-point Likert scale (1=not at all likely; 2=unlikely; 3=likely; 4=extremely likely) how likely they are to engage in sexual activity 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?). α = 0.77 (adapted from L'Engle, Brown, and Kenneavy, 2006)
Condom Use Intentions
Time frame: posttest (approximately one week after pretest)
Participants are asked to indicate on a 4-point Likert scale (1=not at all likely; 2=unlikely; 3=likely; 4=extremely likely) how likely they are to use protection (if you were to have vaginal or anal sex, how likely would you be to use a condom?). (adapted from Jemmott and Jemmott, 1991)
Condom Use Intentions
Time frame: follow-up (approximately three months after pretest)
Participants are asked to indicate on a 4-point Likert scale (1=not at all likely; 2=unlikely; 3=likely; 4=extremely likely) how likely they are to use protection (if you were to have vaginal or anal sex, how likely would you be to use a condom?). (adapted from Jemmott and Jemmott, 1991)
Birth Control Use Intentions (Other Than Condoms)
Time frame: posttest (approximately one week after pretest)
Participants are asked to indicate on a 4-point Likert scale (1=not at all likely; 2=unlikely; 3=likely; 4=extremely likely) how likely they are to use protection (if you were to have vaginal sex, how likely would you be to use birth control other than condoms?). (adapted from Jemmott and Jemmott, 1991)
Birth Control Use Intentions (Other Than Condoms)
Time frame: follow-up (approximately three months after pretest)
Participants are asked to indicate on a 4-point Likert scale (1=not at all likely; 2=unlikely; 3=likely; 4=extremely likely) how likely they are to use protection (if you were to have vaginal sex, how likely would you be to use birth control other than condoms?). (adapted from Jemmott and Jemmott, 1991)
Protection Intentions During Oral Sex
Time frame: posttest (approximately one week after pretest)
Participants are asked to indicate on a 4-point Likert scale (1=not at all likely; 2=unlikely; 3=likely; 4=extremely likely) how likely they are to use protection (if you were to decide to have oral sex, how likely would you be to use a condom or dental dam?). (adapted from Jemmott and Jemmott, 1991)
Protection Intentions During Oral Sex
Time frame: follow-up (approximately three months after pretest)
Participants are asked to indicate on a 4-point Likert scale (1=not at all likely; 2=unlikely; 3=likely; 4=extremely likely) how likely they are to use protection (if you were to decide to have oral sex, how likely would you be to use a condom or dental dam?). (adapted from Jemmott and Jemmott, 1991)
44 secondary outcomes
Perceived Realism of Media Messages
Time frame: posttest (approximately one week after pretest)
Perceived Realism of Media Messages
Time frame: follow-up (approximately three months after pretest)
Acceptance of Dating Violence
Time frame: posttest (approximately one week after pretest)
Acceptance of Dating Violence
Time frame: follow-up (approximately three months after pretest)
Advertisement Deconstruction Skills
Time frame: posttest (approximately one week after pretest)
Advertisement Deconstruction Skills
Time frame: follow-up (approximately three months after pretest)
Media Message Completeness
Time frame: posttest (approximately one week after pretest)
Media Message Completeness
Time frame: follow-up (approximately three months after pretest)
Media Skepticism
Time frame: posttest (approximately one week after pretest)
Media Skepticism
Time frame: follow-up (approximately three months after pretest)
Acceptance of Strict Gender Role Stereotypes
Time frame: posttest (approximately one week after pretest)
Acceptance of Strict Gender Role Stereotypes
Time frame: follow-up (approximately three months after pretest)
Acceptance of Rape Myths
Time frame: posttest (approximately one week after pretest)
Acceptance of Rape Myths
Time frame: follow-up (approximately three months after pretest)
Intentions to Intervene as Bystander
Time frame: posttest (approximately one week after pretest)
Intentions to Intervene as Bystander
Time frame: follow-up (approximately three months after pretest)
Efficacy to Intervene as Bystander
Time frame: posttest (approximately one week after pretest)
Efficacy to Intervene as Bystander
Time frame: follow-up (approximately three months after pretest)
Descriptive Norms Regarding Teen Sexual Activity
Time frame: posttest (approximately one week after pretest)
Descriptive Norms Regarding Teen Sexual Activity
Time frame: follow-up (approximately three months after pretest)
Descriptive Norms Regarding Teen Risky Sexual Activity
Time frame: posttest (approximately one week after pretest)
Descriptive Norms Regarding Teen Risky Sexual Activity
Time frame: follow-up (approximately three months after pretest)
Sexual Health Knowledge
Time frame: posttest (approximately one week after pretest)
Sexual Health Knowledge
Time frame: follow-up (approximately three months after pretest)
Descriptive Norms Regarding Sexual Health Communication
Time frame: posttest (approximately one week after pretest)
Descriptive Norms Regarding Sexual Health Communication
Time frame: follow-up (approximately three months after pretest)
Efficacy to Negotiate Contraception/Protection Use
Time frame: posttest (approximately one week after pretest)
Efficacy to Negotiate Contraception/Protection Use
Time frame: follow-up (approximately three months after pretest)
Efficacy to Use Contraception/Protection
Time frame: posttest (approximately one week after pretest)
Efficacy to Use Contraception/Protection
Time frame: follow-up (approximately three months after pretest)
Descriptive Norms Regarding Teen Birth Control Use
Time frame: posttest (approximately one week after pretest)
Descriptive Norms Regarding Teen Birth Control Use
Time frame: follow-up (approximately three months after pretest)
Efficacy to Communicate Before Sex
Time frame: posttest (approximately one week after pretest)
Efficacy to Communicate Before Sex
Time frame: follow-up (approximately three months after pretest)
Intent to Communicate Before Sex
Time frame: posttest (approximately one week after pretest)
Intent to Communicate Before Sex
Time frame: follow-up (approximately three months after pretest)
Cognitive Elaboration While Viewing an Advertisement
Time frame: posttest (approximately one week after pretest)
Cognitive Elaboration While Viewing an Advertisement
Time frame: follow-up (approximately three months after pretest)
Communication With a Doctor or Other Health Professional About Sexual Health
Time frame: posttest (approximately one week after pretest)
Communication With a Doctor or Other Health Professional About Sexual Health
Time frame: follow-up (approximately three months after pretest)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 31915060Scull TM, Malik CV, Morrison A, Keefe EM. Study protocol for a randomized controlled trial to evaluate a web-based comprehensive sexual health and media literacy education program for high school students. Trials. 2020 Jan 8;21(1):50. doi: 10.1186/s13063-019-3992-1.
- Individual participant dataSharing planned: No. All data collected will only be used for the research purposes in accordance with protocols approved by the IRB.
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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 11 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 28 May 2021. 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?
Yes. Results are posted in the registry (first posted 28 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Willingness to Have Sex (time frame: posttest (approximately one week after pretest)). The study lists 14 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 NCT04035694, 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 28 May 2021.