The Middle Years Study: A Feasibility Study of a Self-paced Program Designed to Provide Parents of Middle School-aged Students With Knowledge About Teen Substance Use and Practice in High Quality Parent-adolescent Communication Methods Delivered Through a Highly Interactive Web-based Software Application
Phase: NA
Conditions: Substance Use, Parenting, Communication
Sponsor: Innovation Research & Training

Study Protocol and Statistical Analysis Plan 
 
Brief Title: Feasibility of a web-based program to help parents of middle school students 
effectively communicate with their children about substance use 
 
Protocol ID: Middle Years Study R21-23-003-001 
 
ClinicalTrials.gov ID: NCT05900115 
 
Principal Investigator: Dr. Tracy Scull (tscull@irtinc.us) 
 
IRB Reviewed Protocol Approval Date: 5/1/2023 
 
 
 
 

Study Protocol and Statistical Analysis Plan 
The purpose of the project, is to evaluate and assess a self-administered, web-based program, 
Media Ready Parent (MRP), designed to increase parent knowledge about adolescent substance 
use, active media mediation skills, and practice high-quality parent-adolescent communication 
methods. The program will help parents of middle-school aged students, 6th-8th graders, 
communicate effectively about substance use and enhance media literacy skills to counter 
unhealthy media messages. Prevention efforts are most impacting for adolescents in middle 
school years as this is the time frame for growing independence, desire to fit-in and an increase 
risk for their own experimentation with substances. 
 
The procedure that will be used for conducting the research study is as follows: 
1. 
We will aim for 286 parent-child pairs (child in 6th, 7th, or 8th) 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% white non-Hispanic 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. The study team will enroll 
eligible, consented 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 condition 1) Media Ready Parent (intervention) or 2) active 
control (i.e., medically-accurate information from sources like the CDC about adolescent 
substance use).  
3. 
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. 
4. 
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.  
See Appendix E for automated messages. 
5. 
Once pretests questionnaires are completed, parents will receive a link to access their 
randomly assigned resource. The resources could take up to 2 hours to review. Parents will 
be asked to completely review their assigned resource within two weeks. If they do so, they 
will be eligible for a $25 gift card.  However, parents will have access to their assigned 
resource for four weeks (until the posttest questionnaire). Parents will receive a reminder 
after one week of receiving access to their resources to complete their review within the 
following week. Parents will receive a final reminder on about the 13th day to complete their 
review of the resource. 
6. 
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 $50 gift card.  
7. 
Control participants will receive access to MRP after study is completed to review as 
desired. 
8. 
Incentives will take the form of gift cards. Participants will be able to choose between 
Amazon and Walmart gift cards. We will mail incentives to participants’ physical address 
after pretest completion (max $30) and after posttest completion (max $75). 
 
Statistical Analysis Plan 
Preliminary Analyses. Psychometric analyses will be conducted to confirm the reliability, 
validity, and distributions of key variables. To establish if there is baseline equivalence between 
groups, we will test for equivalence on basic demographic characteristics (i.e., age, 
race/ethnicity, gender, and sexual orientation) and on baseline levels of our primary outcome 
variables in a series of t-test and χ2 analyses. If we establish that the intervention and control 
groups are not equivalent on any pre-specified variables, these variables will be used as 
covariates in the analyses of intervention effects. Missing data will be handled using multiple 
imputation methods. 
Main Analyses. To examine intervention effects on primary outcomes at posttest, we will use a 
series of linear and logistic regressions in intent-to-treat analyses. For outcomes that have only 
one informant, posttest scores will be regressed onto pretest scores, covariates, and the treatment 
effect. Covariates will include parent gender, youth gender, youth age, parent substance use, 
SES, and supportive parenting.