Online Parent Media Literacy Program to Promote Preadolescent Health
Phase: NA
Conditions: Parenting, Parent-Child Relations, Communication
Sponsor: Innovation Research & Training

Study Protocol and Statistical Analysis Plan 
 
Brief Title: Study of an Online Program to Help Parents Talk with Their Tween Children 
About Health, Gender, Body-Image, and Relationships 
 
Protocol ID: TweenHealthStudy-R21-23-006-01 
 
ClinicalTrials.gov ID: NCT06408818 
 
Principal Investigator: Dr. Tracy Scull 
 
IRB Reviewed Protocol Approval Date:  
Initial Approval:  
 
2/27/2024 
 
Modification Approval:  
5/14/2024 
 
Modification Approval:  
7/13/2024 
 
Modification Approval:  
8/22/2024 
 
 
 

Study Protocol 
The purpose of this project is to assess a self-paced online program, Media Aware Parent: Tween 
(MAP: Tween), designed to provide parents with knowledge about preadolescent development, 
media mediation skills, and practice in high-quality parent-child communication about body 
image, sexual development, gender stereotypes, and romantic relationships. The program will 
help parents of preadolescents (9-12 years of age) have effective conversations with their child 
about these topics and enhance media literacy skills to counter unhealthy media messages. 
Study participants will contribute to the evaluation of a web-based application that will act as a 
resource for parents to have informed high-quality conversations with their preadolescent child 
about body image, sexual development, gender stereotypes, and romantic relationships. Through 
their participation, parents and children in the study may also acquire an increased knowledge 
about these topics and media literacy.    
Preadolescence is a critical stage of development as youth transition from childhood into 
adolescence, and the MAP: Tween program may help improve communication between parents 
and children. High-quality parent-child communication has been shown to positively impact 
youth decision-making and health outcomes; therefore, this program has the potential to benefit 
society by resulting in an evidence-based program to enhance parent-child communication.   
 
The procedure that will be used for conducting the research study is as follows: 
1. 
We will aim to recruit a diverse sample of 300 parent-tween pairs (youth aged 9-12) to 
participate in this study. We will aim to have the sample consist of at least 40% fathers or 
male guardians and no more than 60% non-Hispanic/Latinx white adult participants. Parent-
child pairs will be stratified by parent’s gender and race/ethnicity prior to randomization to 
ensure diversity across groups. 
2. 
A recruitment website will be available. Interested parents can complete an online screener 
found on the website. If eligible, parents will be directed to a place where parents and their 
children can complete the online informed consent process.  
3. 
On the parent permission and consent form, participants will be asked for their preferred 
email address to receive study communications over the study period. 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. Parents will also be asked on the 
permission and consent form to agree to receiving study communication via text. Before 
receiving text communications at their phone number, they will need to verify that they can 
receive texts at their number by clicking on the verification link that is sent via SMS 
message. Finally, parents will also be asked to verify their name and address either through 
uploading on the permission-consent form an image of some form of document that includes 
their name and address (e.g., license; electric bill) or showing the document to a study team 
member through a live web conferencing call (e.g., Zoom call). [Modification: Due to 
concerns of people uploading images of documentation that was photoshopped, during the 
study the verification protocol was modified (and approved by the IRB) so that all 
participants were asked in the screener survey to indicate the school district where their 

child attended school and then this was checked against our list of schools that distributed 
our flyer. Only parents that listed a school district where our flyer was distributed, were 
enrolled.]  
4. 
The study team will enroll eligible, consented, and verified pairs based on whether there is 
room in the study according to gender and race/ethnicity stratification. If there is space in 
the study, parent-child pairs will be randomly assigned to either the Intervention condition 
(receiving the MAP: Tween program) or the Active Control condition (i.e., receiving 
medically-accurate information from sources like the CDC about topics such as 
preadolescent development, body-image, gender, and relationship health).  
5. 
Pretest questionnaires for parents and their children will be distributed to enrolled parents in 
two separate emails/texts containing a link to complete their respective questionnaires. 
Participants will have one week to complete their questionnaires. If both the parent and 
child complete their questionnaire, they will be eligible for a $30 gift card. 
6. 
Parents will receive a reminder (email, phone call, or text) to complete the pretest 
questionnaires if both are not completed in the first two business days. If both 
questionnaires are not completed, the parent will receive a final reminder around the 6th day.  
7. 
Once pretests questionnaires are completed, parents will receive a link to access their 
randomly assigned resource (i.e., MAP: Tween OR medically-accurate information from 
sources like the CDC). The resources could take up to a total of 2 hours to review over the 
course of 3 weeks. Parents who complete the program within 3 weeks will be eligible to 
take the parent feedback questionnaire. Completion of the feedback questionnaire may take 
up to 15 minutes. If the parent completes the questionnaire, they will be eligible for a $40 
gift card.  
8. 
About four weeks after pretest questionnaire completion, parents will receive two 
emails/texts – one with a link to their posttest questionnaire and one with a link to their 
child’s posttest questionnaire. Participants will have one week to complete their 
questionnaires. If both the parent and child complete their questionnaire, they will be 
eligible for a $45 gift card. Parents will receive a reminder (email, phone call, or text) to 
complete the posttest questionnaires if both are not completed in the first two business days. 
If both questionnaires are not completed, the parent will receive a final reminder around the 
6th day. 
9. 
Incentives will take the form of gift cards. Participants will be emailed the appropriate 
Amazon.com electronic gift card after completing the study questionnaires.   
 
Statistical Analysis Plan 
 
Preliminary Analyses. Psychometric analyses will be conducted to study the reliability, validity, 
and distributions of key variables. These analyses will be conducted by first assessing the 
internal consistency (i.e., Cronbach’s alphas) of outcomes with Likert-type scales. If the alpha 
for an outcome is unacceptable (i.e., less than 0.70), then items that do not correlate strongly 
with the total scale will be removed, one-at-a-time, until the alpha for the scale is acceptable. 
Once items are averaged together to create the scale, outcome distributions will be assessed 
using univariate analyses to examine skewness and kurtosis, providing preliminary inside into 
potential deviations from normality prior to model fitting. If outcomes are unacceptably skewed 
or kurtotic, then outcomes scales will be modified (via re-scaling or dichotomizing) or eliminated 

from analysis. The impact of random assignment on producing equivalent groups will be 
assessed on pretest demographic and background characteristics in a series of t-tests and χ2 
analyses. If we establish that the groups are not equivalent on any pre-specified variables, these 
variables will be used as covariates in the analyses of intervention effects. For continuous 
outcomes, normality assumptions will be tested using the Shapiro-Wilk test, Q-Q plots, and 
histogram of the residual distributions, via linear regression analyses of raw data, with all 
covariates included in the model. If the Shapiro-Wilk test is significant (p-value of w <.05), the 
histogram of residuals deviates substantially from a bell curve, and the Q-Q plot includes a 
pronounced S-curve (deviates substantially from the line), then the outcome scale will be 
transformed (via re-scaling or dichotomizing) or eliminated from analyses. Finally, we will use 
multiple imputation to handle missing data and analyses will be conducted on each imputed 
dataset, with resulting estimates and standard errors pooled using Rubin’s Rules.  
 
Main Analyses. Analyses will examine the effects of the program on attitudes, cognitions, and 
behaviors, which will provide information on program feasibility. We will use a series of linear 
regressions for outcomes with continuous distributions and logistic regressions for dichotomous 
(yes/no) outcomes in intent-to-treat analyses. Posttest scores will be regressed onto pretest 
scores, covariates, and the intervention effect. Covariates will include those that were non-
equivalent between groups at pretest, parent sex, child sex, socioeconomic status, and parent- 
and child-reported supportive parenting. The Benjamini-Hochberg procedure will be employed 
to control for the False Discovery Rate (FDR).