Clinical trial NCT04035694: Evaluation Study of the Online High School Media Aware Program
Official title: Web-based High School Media Literacy for Healthy Relationships
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sexual Behavior
Keywords: Adolescent sexual health
Media literacy education
Web-based programming
Lead sponsor: Innovation Research & Training
Sponsor class: OTHER
First posted: 2019-07-29
Enrollment: 590
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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. 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.


Eligibility criteria: SCHOOL SITES:

Inclusion:

1. 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.
2. 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.
3. Schools must have adequate technology for the students to use the web-based Media Aware program and complete the online questionnaires.
4. It must be feasible for iRT project staff members to travel to the school sites for the three data collection time points.

TEACHER PARTICIPANTS:

Inclusion:

1. Teacher's classrooms must have students in 9th or 10th grade as this program is designed for use in these grades.
2. 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:

Inclusion:

1. Students must be in grades 9 or 10.
2. 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.
3. Students must have appropriate parent permission to receive sexual health education per school districts' policy (i.e., opt-in policy or opt-out policy).

Primary outcomes:
measure: Willingness to Have Sex
timeFrame: posttest (approximately one week after pretest)
measure: Willingness to Have Sex
timeFrame: follow-up (approximately three months after pretest)
measure: Willingness to Engage in Unprotected Sex
timeFrame: posttest (approximately one week after pretest)
measure: Willingness to Engage in Unprotected Sex
timeFrame: follow-up (approximately three months after pretest)
measure: Willingness to Hook up
timeFrame: posttest (approximately one week after pretest)
measure: Willingness to Hook up
timeFrame: follow-up (approximately three months after pretest)
measure: Intentions to Engage in Sexual Activity With Another Person
timeFrame: posttest (approximately one week after pretest)
measure: Intentions to Engage in Sexual Activity With Another Person
timeFrame: follow-up (approximately three months after pretest)
measure: Condom Use Intentions
timeFrame: posttest (approximately one week after pretest)
measure: Condom Use Intentions
timeFrame: follow-up (approximately three months after pretest)
measure: Birth Control Use Intentions (Other Than Condoms)
timeFrame: posttest (approximately one week after pretest)
measure: Birth Control Use Intentions (Other Than Condoms)
timeFrame: follow-up (approximately three months after pretest)
measure: Protection Intentions During Oral Sex
timeFrame: posttest (approximately one week after pretest)
measure: Protection Intentions During Oral Sex
timeFrame: follow-up (approximately three months after pretest)
Secondary outcomes:
measure: Perceived Realism of Media Messages
timeFrame: posttest (approximately one week after pretest)
measure: Perceived Realism of Media Messages
timeFrame: follow-up (approximately three months after pretest)
measure: Acceptance of Dating Violence
timeFrame: posttest (approximately one week after pretest)
measure: Acceptance of Dating Violence
timeFrame: follow-up (approximately three months after pretest)
measure: Advertisement Deconstruction Skills
timeFrame: posttest (approximately one week after pretest)
measure: Advertisement Deconstruction Skills
timeFrame: follow-up (approximately three months after pretest)
measure: Media Message Completeness
timeFrame: posttest (approximately one week after pretest)
measure: Media Message Completeness
timeFrame: follow-up (approximately three months after pretest)
measure: Media Skepticism
timeFrame: posttest (approximately one week after pretest)
measure: Media Skepticism
timeFrame: follow-up (approximately three months after pretest)
measure: Acceptance of Strict Gender Role Stereotypes
timeFrame: posttest (approximately one week after pretest)
measure: Acceptance of Strict Gender Role Stereotypes
timeFrame: follow-up (approximately three months after pretest)
measure: Acceptance of Rape Myths
timeFrame: posttest (approximately one week after pretest)
measure: Acceptance of Rape Myths
timeFrame: follow-up (approximately three months after pretest)
measure: Intentions to Intervene as Bystander
timeFrame: posttest (approximately one week after pretest)
measure: Intentions to Intervene as Bystander
timeFrame: follow-up (approximately three months after pretest)
measure: Efficacy to Intervene as Bystander
timeFrame: posttest (approximately one week after pretest)
measure: Efficacy to Intervene as Bystander
timeFrame: follow-up (approximately three months after pretest)
measure: Descriptive Norms Regarding Teen Sexual Activity
timeFrame: posttest (approximately one week after pretest)
measure: Descriptive Norms Regarding Teen Sexual Activity
timeFrame: follow-up (approximately three months after pretest)
measure: Descriptive Norms Regarding Teen Risky Sexual Activity
timeFrame: posttest (approximately one week after pretest)
measure: Descriptive Norms Regarding Teen Risky Sexual Activity
timeFrame: follow-up (approximately three months after pretest)
measure: Sexual Health Knowledge
timeFrame: posttest (approximately one week after pretest)
measure: Sexual Health Knowledge
timeFrame: follow-up (approximately three months after pretest)
measure: Descriptive Norms Regarding Sexual Health Communication
timeFrame: posttest (approximately one week after pretest)
measure: Descriptive Norms Regarding Sexual Health Communication
timeFrame: follow-up (approximately three months after pretest)
measure: Efficacy to Negotiate Contraception/Protection Use
timeFrame: posttest (approximately one week after pretest)
measure: Efficacy to Negotiate Contraception/Protection Use
timeFrame: follow-up (approximately three months after pretest)
measure: Efficacy to Use Contraception/Protection
timeFrame: posttest (approximately one week after pretest)
measure: Efficacy to Use Contraception/Protection
timeFrame: follow-up (approximately three months after pretest)
measure: Descriptive Norms Regarding Teen Birth Control Use
timeFrame: posttest (approximately one week after pretest)
measure: Descriptive Norms Regarding Teen Birth Control Use
timeFrame: follow-up (approximately three months after pretest)
measure: Efficacy to Communicate Before Sex
timeFrame: posttest (approximately one week after pretest)
measure: Efficacy to Communicate Before Sex
timeFrame: follow-up (approximately three months after pretest)
measure: Intent to Communicate Before Sex
timeFrame: posttest (approximately one week after pretest)
measure: Intent to Communicate Before Sex
timeFrame: follow-up (approximately three months after pretest)
measure: Cognitive Elaboration While Viewing an Advertisement
timeFrame: posttest (approximately one week after pretest)
measure: Cognitive Elaboration While Viewing an Advertisement
timeFrame: follow-up (approximately three months after pretest)
measure: Communication With a Doctor or Other Health Professional About Sexual Health
timeFrame: posttest (approximately one week after pretest)
measure: Communication With a Doctor or Other Health Professional About Sexual Health
timeFrame: follow-up (approximately three months after pretest)
measure: Communication With a Parent or Other Trusted Adult About Sexual Health
timeFrame: posttest (approximately one week after pretest)
measure: Communication With a Parent or Other Trusted Adult About Sexual Health
timeFrame: follow-up (approximately three months after pretest)
measure: Communication With a Boyfriend or Girlfriend About Sexual Health
timeFrame: posttest (approximately one week after pretest)
measure: Communication With a Boyfriend or Girlfriend About Sexual Health
timeFrame: follow-up (approximately three months after pretest)
Other outcomes:
measure: Counterarguing While Viewing an Advertisement
timeFrame: posttest (approximately one week after pretest)
measure: Counterarguing While Viewing an Advertisement
timeFrame: follow-up (approximately three months after pretest)
measure: Advertisement Credibility
timeFrame: posttest (approximately one week after pretest)
measure: Advertisement Credibility
timeFrame: follow-up (approximately three months after pretest)
Locations:
city: Durham
country: United States
facility: innovation Research and Training
state: North Carolina
Study officials:
References:
citation: 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.