NCT04035694

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
590

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 16, 2019

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 29, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

September 10, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 5, 2020

Completed
12 months until next milestone

Results Posted

Study results publicly available

May 28, 2021

Completed
Last Updated

May 28, 2021

Status Verified

March 1, 2021

Enrollment Period

9 months

First QC Date

July 16, 2019

Results QC Date

March 8, 2021

Last Update Submit

May 5, 2021

Conditions

Keywords

Adolescent sexual healthMedia literacy educationWeb-based programming

Outcome Measures

Primary Outcomes (14)

  • 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?).

    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?).

    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)

    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)

    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)

    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)

    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)

    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)

    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)

    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)

    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)

    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)

    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)

    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)

    follow-up (approximately three months after pretest)

Secondary Outcomes (44)

  • Perceived Realism of Media Messages

    posttest (approximately one week after pretest)

  • Perceived Realism of Media Messages

    follow-up (approximately three months after pretest)

  • Acceptance of Dating Violence

    posttest (approximately one week after pretest)

  • Acceptance of Dating Violence

    follow-up (approximately three months after pretest)

  • Advertisement Deconstruction Skills

    posttest (approximately one week after pretest)

  • +39 more secondary outcomes

Other Outcomes (4)

  • Counterarguing While Viewing an Advertisement

    posttest (approximately one week after pretest)

  • Counterarguing While Viewing an Advertisement

    follow-up (approximately three months after pretest)

  • Advertisement Credibility

    posttest (approximately one week after pretest)

  • +1 more other outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

Participants will receive access to Media Aware.

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.

Interventions

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.

Also known as: Media Aware
Intervention

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.
  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

innovation Research and Training

Durham, North Carolina, 27713, United States

Location

Related Publications (1)

  • 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.

    PMID: 31915060BACKGROUND

MeSH Terms

Conditions

Sexual Behavior

Condition Hierarchy (Ancestors)

Behavior

Limitations and Caveats

The COVID-19 pandemic began during this trial, and primarily impacted the collection of follow-up data. Data collection procedures were revised to take into account social distancing measures and schools switching to remote learning. Response rates were lower and analyses revealed systematic differences between groups; therefore, data from these students were not included in the follow-up analyses.

Results Point of Contact

Title
Dr. Tracy Scull
Organization
innovation Research & Training

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 16, 2019

First Posted

July 29, 2019

Study Start

September 10, 2019

Primary Completion

June 5, 2020

Study Completion

June 5, 2020

Last Updated

May 28, 2021

Results First Posted

May 28, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

All data collected will only be used for the research purposes in accordance with protocols approved by the IRB.

Locations