Aim, design, and setting
The study design evaluates web-based randomized controlled trial substance abuse prevention and substance abuse media literacy (SAML) education programs. It is expected that approximately three universities include: Hamadan University of Medical Sciences, Islamic Azad University Hamadan Branch, and Bu-Ali Sina University, will take part in the study. Data will be collected from students at two-time points (i.e., pre-test and three months follow-up). Interventional research will be based on the SMART pattern.
SMART is the operational model of social marketing in the field of health, which is used to improve the behavior of society in the field of health, which includes the stages of preliminary planning, formative research (customer analysis, market analysis, channel analysis), production of interventions, materials and pre-tests, intervention and Execution is evaluation (Figure 2).
Outcomes will obtain in the experimental study.
It should be noted that in this model, previous formative research including qualitative and descriptive studies to complete steps one to five of the SMART model, to determine the type of intervention and products including getting detailed information about audience peculiarities, behavioral market and communication channel by audience analysis, market analysis, and channel analysis. In a qualitative study, the need's audience and desires were identified, behavioral market determinants such as partners and components of the marketing mix, and channels were specified. An effective communication strategy was developed, which were the results of this study.
Here are three questions: 1) what is the highest prevalence of addictive substances in students? 2)Which University is the most addictive in the region? 3) Which behavioral and non-behavioral factors are involved in the health problem? For the response to these questions in the descriptive study, which is a quantitative part of formative research, students' demographic information and drug abuse behavior were assessed based on the prototype willingness model and media literacy related to substance abuse. Analysis of the qualitative and quantitative parts of formative research identified the main components of the intervention. Then, this study (protocol study) will be performed to complete the SMART model's sixth and seventh stages, including the implementation of intervention and evaluation.
It is anticipated that up to 116 students may take part in the study. This study would have taken place during the 2020 -2021 school year. Additionally, program completion and feedback on process evaluation (satisfaction, availability, and quality of material education) will be gathered from intervention students. The research team used the SPIRIT checklist for Interventional Trials to prepare this study (23).
Sample size & Eligibility criteria
According to previous studies, if the intervention's minimum effectiveness is 20% (24), taking in to account the clustering coefficient of 1.5, alpha 5%, and 90% the desired power, we need 54 people per group. Also, considering the 20% probability of Attrition in the intervention process, the present study sample size was 116, including 58 in the experimental group and 58 in the control group.
Inclusion criteria for participants will be Access to the Internet and Social Networks such as
What's app, telegram, and Instagram; Being a student in one of the universities in the city of
Hamadan and they be interested in participating in the study. Before participation, Students will complete a written informed consent letter to participate in this study. Principal Investigator will access consent forms of student participant data that it will be namelessly. In consent letter also, explained that students can exit the study if they aren't willing to continue.
Internal Review Board approval
Present article extracted from the Ph.D. thesis in Health Education and Health Promotion, this study was approved by the Research Ethics Committee of Hamadan University of Medical Sciences with a number 9811018459 and had the special ID of the Ethics Committee of IR.UMSHA.REC.1398.827.
Recruitment will occur at two planes: university schools and students. It is essential mansions, Hamadan City is located in the west of Iran. It has four state universities, including Bu-Ali Sina University, Hamadan University of Medical Sciences, Hamadan University of Applied Sciences & Technology, and the Hamadan University of Technology. Moreover, it has some non-governmental universities such as Islamic Azad University Hamadan Branch and Hamadan Payam Noor University (25) . Substance Abuse Media Literacy scale and scale of substance abuse behavior based on the prototype willingness model will be evaluated in this study.
Schools of University
First university permission for conducting this study will be obtained. University administrators will access questionnaires for an estimate if demanded. Efforts will be made to balance the inclusion of both state and non-state universities and to range in their sociodemographic characteristics. Based on the previous formative research (26) and random sampling of Hamadan universities, around three universities are expected to participate. Therefore, the number of students in each school or university will be obtained by proportional assignment of students to the school (i.e., the school with the largest number of students, the largest number of students assigned) after coordinating with university officials, the research units will be rationed. Then, the samples will be randomly collected.
It is anticipated that up to 161 students may be employed to participate in this study. Research team members will introduce the aims of the survey to students and distribute consent forms. Students will be eligible to participate if they are members of Hamadan universities, are enrolled, and have an appropriate willingness to receive Substance Abuse Media Literacy and Substance abuse prevention education. Students will complete consent and permission forms, respectively, before the study initiates.
After the Research Ethics Committee Hamadan University of Medical Sciences' approval, the Principal Investigator will share a copy of the revised protocol with all the research team members to ensure awareness of the reconsiderations. The research team will document any unexpected deviations from the protocol. Concerning the Data and Safety Monitoring Plan, the Research Ethics Committee of Hamadan University of Medical Sciences will be informed of any updates and modifications.
Randomization will occur using stratified random sampling procedure by research team; individuals are assigned to two intervention and control groups. Randomization will occur after students complete informed consent and appropriate school and university approvals for carrying out the study.
The intervention description
Substance Abuse Media Literacy and preventive substance abuse educations are web-based, comprehensive education programs for university students that provide appropriate and medically accurate information about Substance abuse using a Media literacy education approach. The pairing of preventive substance abuse information and substance abuse media literacy education allows the program to teach students critically thinking about media messages related to substance abuse and substance abuse behavior. It mostly teaches them what Lifestyles, Values, and Points of View Represented in, or omitted From, Media Messages About Substance Abuse, such as identification and the possible implications of actual consumption of drugs, such as simulating an actor, having instant excitement, believing in the non-addictive nature of advertised substance, and having ideal moods and herbal and not harmful.
Educations consists of ﬁve web-based education sessions about substance abuse prevention and substance abuse media literacy. Each session includes 40-45 minutes of training with the question and answer methods. Group discussion (Chat rooms) will be held with multimedia Tools and reminder messages, such as the ﬁrst educational session to familiarize students with Drugs and substance abuse consequences. The second session aimed to educate students with substance abuse media literacy skills, critical thinking, and the media consumption regime. The third session aimed at familiarizing students with interpersonal skills and self-awareness and the fourth session will introduce students to the saying no skills and problem-solving. The ﬁfth session will correct students' beliefs and attitudes towards substance abuse with the mentioned web-based teaching methods and materials—each containing group discussion in the chatting room. Educations were developed by an interdisciplinary group consisting of specialists in psychology, media research, web site development, multimedia design, health education, and promotion. The intervention group students will receive lessons between completing the pre-test and the follow-up (Fig. 3). The website will contain an educator dashboard for educators. They will be one of the research teams to enroll the students in the program and group discussions, including student chatroom, to correct their belief about drugs. Educators will also have the right to use web-based education programs to help students prepare to simplify accessibility to education. All educators will be requested to review all of the materials.
Disincentives Students will receive a gift card of $30 for participating in the study. Participating in all data gathering phases (two times) will be drawing for a $50 gift card at follow-up. Students will have access until the end of the semester to Substance Abuse Media Literacy and Substance abuse prevention educations.
Students in the delayed intervention group will obtain lessons during the study, but educators will be requested to abstain from any substance abuse or SAML topics. Simultaneously, Educators in the delayed-intervention group will not train them until after study completion (i.e., collecting student data at three months follow-up).
As mentioned, participants in this study are familiar with E-learning class and online education for other courses, especially in the coronavirus crisis. Educators will obtain access to the web-based educator's control panel, giving them access to programs. The Principal Investigator and all research team will visit the website. Privacy shields will be given to block their computer or tablet screens from view to ensure confidentiality. Secret ID numbers will be used in place of names in the chat room, and during receiving education programs, admin and educator sessions were offered to students before education. Students will be instructed that they may withdraw from the study at any time for any reason. Follow-up questionnaires will be completed with paper copies of the pre-test questionnaire. After pre-test data collection is completed, educators in the intervention group will educate substance abuse prevention and substance abuse media literacy educations over three weeks. It is predicted that the program could be done in five 45-min. At up fallow period, students in the intervention group will also make available program feedback. Educators will return all answers to the follow-up questionnaire to administer and Principal Investigator after approximately three months. After the follow-up data are collected, educators in the delayed-intervention group can train substance abuse media literacy and substance abuse prevention education with students and provide feedback on their experiences.
Students will complete questionnaires at two-time points: pre-test and three months follow-up (Fig. 1). The student questionnaire, containing around 100 items, will cover substance abuse behavior based on the prototype willingness model variables outcomes (e.g., attitudes, normative beliefs, behavioral intentions, willingness), and self-reports of substance abuse media literacy scale (SAMLS) and process evaluation. In addition to Demographic questions will comprise the student's age, education level, and socioeconomic status, sex, gender, parental education level, Marital Status, Name of University, schools and courses, History of smoking and alcohol consumption, Addiction status in parents, Close Friends substance abuse status, Internet access, amount of social media exposure and use of social media, motivation to use social media.
-Scales of substance abuse behavior based on the prototype willingness model includes constructs of attitude, subjective norms, behavioral willingness, as well as prototype and intents of behavior (27).
- Substance Abuse Media literacy Scale (SAMLS) with 13 questions.
-Process evaluation checklist
Process evaluation includes Student satisfaction, availability of material education, quality of material education will be asked items to indicate on 5-point Likert scales.
Plans to promote participant retention and complete follow-up
It is essential to be mention, after complete inform consent letter by students, Participants will be given randomly assigned ID numbers to be used in the education program. A list of names and ID numbers will be reserved privately on a secure server accessible to the principal Investigator and the administration staff (who are skilled in the ethical study). If any participant who discontinue or deviate from education plan, administration staff will effort to encourage him/her to participated to study during two contact.
Students participating in the study will be placed in intervention or control groups (delayed intervention group) after obtaining informed consent. Trials are planned so that people are aware of all the aims of the study. Based on the research group's planning, all members of the intervention or delayed-intervention group will have access to all educations. The intervention group members will be educated initially, and the members of the delayed-intervention group will receive training three months after receiving the post-test results. It is necessary to mention; students are unaware of assignments to studying groups.
Fidelity of implementation Process
These educations will be start and end based on research team planning. The real lessons of the online session will be accessible to all students without any deficiency.
The data will be analyzed with Spss-23 using chi-squared, independent T-test analyses, and other tests. If necessary, missing data will be examined at each time point and handled with an appropriate imputation method. All data of the full protocol and intervention study are potentially shareable after unidentiﬁed Individuals. All researchers who request to vice Chancellor for Research and Technology of Hamadan University of Medical Sciences data access is obtainable.
Oversight and monitoring
As mentioned, this study will be performed to complete the SMART model's sixth and seventh stages, including the implementation of intervention and evaluation. Confidentiality will be assured to all participants. Participants will be given randomly assigned ID numbers to be used in the education program. A list of names and ID numbers will be reserved privately on a secure server accessible to the principal Investigator and the administration staff (who are skilled in the ethical study). After the ended education in fallow- up time, collection of data will occur. Students complete questioners with a number answer. Identifying information couldn't be shared by the student, so, Secret ID numbers will be used in place of names in the chat room and receiving education programs. This study is a minimal risk. Any adverse events that occur will be informed to the Principal Investigator and reported to the Research Ethics Committee Hamadan University of Medical Sciences to make the final decision to terminate the trial or continue it.
Serious adverse events will be evaluated within 24 h, and any other challenges will be considered within 72 h; reporting to the Research Ethics Committee Hamadan University of Medical Sciences will occur within two weeks. Procedure of auditing is checked by Principal Investigator 3 times, when includes drafting proposal, conducting study and end of study.
Ethics and dissemination
Vulnerable University Students will be recruited for this study by the Research Ethics Committee of Hamadan University of Medical Sciences. The study team will receive student assent. Researcher contact information will be printed on the forms in case students have questions about the study. Also, this study was approved by the Research Ethics Committee of Hamadan University of Medical Sciences with a number 9811018459 and had the particular ID of the Ethics Committee of IR.UMSHA.REC.1398.827.
All data is potentially shareable after unidentiﬁed individuals. All researchers request data access to the Vice-Chancellor for Research and Technology of Hamadan University of Medical Sciences. It is necessary to be mention that results from this study will be prepared for publication in scholarly journals and updated in https://www.irct.ir/.
As it mentions, confidentiality will be assured to all participants in all process of implementation procedure and monitoring since of end of education programs. Participants will be given randomly assigned ID numbers to be used in the education program. A list of names and ID numbers will be reserved privately on a secure server accessible to the Principal Investigator and the administration staff (who are skilled in the ethical study).
 Social Marketing Assessment and Response Tool (SMART)