The Community College Health Study: A Study of Long-term Efficacy and Mechanisms Underlying the Impact of a Web-based Sexual and Relationship Health Promotion Program With Young Adult Community College Students
Phase: NA
Conditions: Sexual Behavior, Sexual Assault, Violence, Domestic
Sponsor: Innovation Research & Training

Study Protocol and Statistical Analysis Plan 
 
Brief Title: Study of Long-term Efficacy and Mechanisms Underlying the Impact of a Web-
based Sexual and Relationship Health Promotion Program with Young Adult Community 
College Students 
 
Protocol ID: CCHealthStudy-R01-20-007 
 
ClinicalTrials.gov ID: NCT04950686 
 
Principal Investigator: Dr. Tracy Scull (tscull@irtinc.us) 
 
IRB Reviewed Protocol Approval Date:  
Initial Approval: 9/08/2020  
First Year Renewal: 9/03/2021 
Second Year Renewal: 8/25/2022  
 
Third Year Renewal: 8/21/2023 
 
 
 
 

Study Protocol and Statistical Analysis Plan 
The purpose of this study is to conduct a three-arm randomized control trial with older 
adolescents (i.e., ages 18-19) attending community college. Community college campuses were 
randomized to either the: (1) intervention group (i.e., MASH-YA); (2) active control group (i.e., 
sexual health programming from MASH-YA without MLE content); or, (3) wait-list control 
group. Students from each campus completed online questionnaires at pretest, posttest, 6m, and 
12m follow-ups. Using this research design, there were several specific aims of this project. First, 
while research has shown that media literacy education (MLE) is an effective approach to sexual 
health education, little is known about the independent effects of using MLE in sexual health 
programming over and above sexual health programming that does not include MLE. Therefore, 
Aim 1 is to evaluate the incremental effects of MLE on primary and secondary health outcomes. 
Second, research is needed to better understand the mechanisms underlying MLE’s impact on 
sexual health outcomes and explore how these effects may differ from the mechanisms 
underlying the effects of sexual health programming that does not include MLE. Understanding 
the mediators of behavioral effects would advance theory and inform the development of other 
theory-based MLE prevention programs. Therefore, Aim 2 is to compare the mechanisms 
underlying MASH-YA’s effects on health outcomes to the mechanisms underlying the effects of 
the active control program. Third, while a previous study established MASH-YA’s immediate 
positive effects on older adolescents’ media processing and sexual health outcomes, research is 
needed to explore if the program’s effects are enhanced, diminished, or sustained over time. 
Therefore, Aim 3 is to evaluate the long-term efficacy of MASH-YA on proximal (i.e., media 
literacy skills; sexual health cognitions, beliefs, intentions, and willingness) and distal outcomes 
(i.e., sexual behaviors; dating violence; sexual assault) compared to active control and wait-list 
control groups. Replication of the findings from a short-term evaluation of MASH-YA in 
conjunction with evidence of long-term behavioral effects would establish a strong evidence 
base for the effectiveness of the MASH-YA program for use with community college students 
and would help identify how to optimize the long-term impact of the program on health 
behaviors (e.g., include boosters).  
 
The procedure for conducting the research study is as follows: 
1. Approximately thirty community college campus sites will be randomized to one of the 
three conditions and approximately 67 students will be recruited to participate from each 
of the campuses. 
2. Interested students will complete a brief eligibility screener on the study website. They 
will be notified onscreen immediately if they are potentially eligible to participate. To 
pass this first screener, students must meet the aforementioned inclusion criteria. Other 
screener questions are included to gather demographic data that will be used to ensure 
diversity of the sample and used to distract students from the key eligibility questions. 
3. Students who do not pass the first screener will receive a message telling them they are 
not eligible, thanking them for their interest, and providing the study team email address 
in case of questions. No personally identifying information will be collected from 
ineligible students at this stage. 
4. Students that pass the first screener will be directed to a second screener. The purpose of 
this screener is to determine if the student is enrolled at a community college campus that 
is one of the campuses the study is recruiting from. This screener asks students to input 

their community college/campus, college email address, and a contact phone number. If 
the student does not have a college email address, they may select to be contacted by a 
study team member to verify their college enrollment. 
5. After completion of the second screener, potential participants will be directed to the 
online consent form. Students will see one of three messages at the top of the consent 
form, depending on whether or not the system was able to automatically verify that their 
college campus is a study recruitment site. In the interest of providing a smooth 
experience to the participant if their college campus becomes a recruitment site later, the 
system allows all individuals who complete the second screener to complete the consent 
form. Potential participants are encouraged to contact research staff members with any 
questions. 
6. Students who wish to be considered for participation in the study will complete the online 
consent form, which includes a place to indicate consent to participate; enter their contact 
information, contact preferences, and secondary contact information; and verify their age 
(i.e., choose to upload a temporary photo of their ID or request to be contacted by a study 
team member). Participants will be asked to verify their age either through uploading on 
the consent form an image of some form of ID that includes a birthdate or showing the ID 
to a study team member in person (when available) or through web conferencing. After a 
study team member verifies the age from an uploaded image, the image will be deleted. 
Participants do not necessarily have to show proof of ID to be enrolled in the study, but 
the research team will attempt to verify all participants’ age at some point during their 
time in the study. 
7. Study staff will initially scan incoming consent forms for students enrolled at designated 
campuses. Any students who indicate that they attend a campus that is not part of the 
study will be marked as ineligible. (As new campuses are added to the study, study staff 
will review “ineligible” individuals and may categorize them as “eligible” if recruitment 
begins at their campus.) 
8. Potentially eligible students who provide a college email address on the consent form will 
receive an email with a link to verify their email address. If a student had indicated on the 
screener that they do not have access to a college email address or do not click the link to 
verify their college email address, a study team member will contact the student to obtain 
proof of student status. Acceptable methods may include emailing a picture of their 
college ID or showing it on a video call, or providing some other proof that they are 
enrolled at the stated college. Students cannot be enrolled in the study until student status 
is verified. 
9. On the consent form, participants will be asked for their preferred email address to 
receive study communications and incentives (Amazon gift cards) over the study period 
of one year. Before receiving communications at this address, they will need to verify 
that they can receive emails at this address by clicking a link that is emailed to them. 
10. Students will also be asked on the consent form to provide their study communication 
preference for receiving survey links and reminders (email or email/text) on the consent 
form. Upon submitting the consent form, anyone who opts-in to receive texts will receive 
an SMS message with a verification link to determine that they can receive texts at their 
number. 
11. Researchers may need to contact participants if they have information left blank on the 
consent form. 

12.  To ensure a diverse sample with respect to race, ethnicity, and gender, not all eligible 
students that complete consent forms will be enrolled in the study. If space is available in 
the study and the eligible participant is a student at one of the designated community 
college campuses, a member of the project staff will enroll the participant into the study 
arm to which their campus was randomized. 
13. Upon enrollment, participants will receive a link to complete the online pretest 
questionnaire via text or email, depending on the communication preference they 
indicated on the consent form. Participants will be asked to complete the questionnaire 
within seven days and will receive reminders if not completed. If participants do not 
complete the pretest questionnaire in seven days, a researcher will follow-up through 
email, phone, or text. After another seven days have passed, if the student has not 
completed the pretest, they will be dropped from the study. A new participant will be 
enrolled in their place, when possible. 
14. Upon completion of the pretest questionnaire, participants will receive a different link 
depending on condition. Participants on campuses assigned to the intervention group will 
receive a link to review Media Aware. Participants on campuses in the active control 
group will receive a link to review the active control program. Both of these groups will 
be told they will have two weeks to review their program and complete the Student 
Feedback Questionnaire (SFQ) when they have finished reviewing their assigned 
program. However, participants in the intervention and active control groups will have 
access to their assigned programs for another two weeks, until the posttest. After 
completing the pretest, participants on campuses assigned to the wait-list control group 
will receive a message stating that the next step will be another questionnaire in four 
weeks. 
15. Links for future questionnaires will be sent based on the completion date of the pretest 
questionnaire: posttest (after four weeks); 6m follow-up; 12m follow-up. 
16.  A few weeks before the 6-month questionnaire and 12-month questionnaires are sent, a 
check-in message will be sent to the participants preferred and college email address to 
confirm that the address is still valid. Researchers will follow-up with participants who 
do not respond to the email. 
17. Once the wait-list control participants complete the 12m follow-up questionnaire, they 
will receive a link to access Media Aware and be asked to review the program and 
complete the Student Feedback Questionnaire (SFQ). Wait-list control participants will 
be told they will have two weeks to review their program and complete the Student 
Feedback Questionnaire (SFQ) when they have finished reviewing their assigned 
program. However, they will have access to Media Aware for another two weeks. 
18. Students participating in the study will receive a $20 Amazon e-gift card for completing 
the pretest questionnaire, a $30 Amazon e-gift card for completing the review of the 
program and Student Feedback questionnaire (SFQ), a $30 Amazon e-gift card for 
completing the posttest questionnaire, a $40 Amazon e-gift card for completing the 6-
month follow-up questionnaire, and a $50 Amazon e-gift card for completing the 12-
month follow-up questionnaire. Students who complete all study components will receive 
$170 in Amazon e-gift cards over the course of the year-long study. 
 
 
 

Statistical Analysis Plan 
Preliminary Data Analyses. Preliminary analyses may involve data entry and management 
activities. Qualitative data will be coded by trained study team members, and reliability will be 
calculated. Psychometric analyses will be conducted to study the reliability, validity, and 
distributions of key variables. Missing data may be handled in each outcome analysis (i.e., 
posttest, 6m follow-up; 12m follow-up) with an appropriate imputation method, and estimates 
and standard errors will be pooled and adjusted for imputations, if warranted (Schafer, 1997). 
Clinical Trials Outcome analyses. A series of multilevel regression analyses will be conducted to 
test for the effectiveness of the intervention versus the wait-list control group as well as the 
intervention versus the active control group on students’ primary and secondary health outcomes 
and media-related outcomes at the post-intervention, 6m, and 12m follow-up. These analyses 
should reveal if Media Aware improves primary and secondary health outcomes and if those 
effects last, degrade, or emerge over six and twelve months.  
 
For additional information see:  
Scull, T. M., Dodson, C. V., Evans-Paulson, R., Reeder, L. C., Geller, J., Stump, K. N., & 
Kupersmidt, J. B. (2022). Evaluating the mechanisms and long-term effects of a web-based 
comprehensive sexual health and media literacy education program for young adults attending 
community college: study protocol for a three-arm randomized controlled trial. Trials, 23(1), 
521.