<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20200914048719N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-10-06</date_registration>
      <primary_sponsor>Hamedan University of Medical Sciences</primary_sponsor>
      <public_title>Effect of an Educational Intervention Based on Media Literacy on Substance Abuse Prevention among College Students</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of Educational Intervention Based on Media Literacy on Substance Abuse Prevention among College Students Applying the Integrated Social Marketing Approach: a clinical trial study</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-12-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>116</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/50946</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Using Block randomization (quadruple blocks), individuals are assigned to two groups of intervention and control, Blinding description: Students participating in the study will be placed in intervention or control groups (delayed intervention group) after obtaining informed consent. Trials that are planned in such a way that people are aware of all the aims of the study, based on the planning of the research group, all members of the intervention or control group will have access to all educations. The members of the intervention group will be educated at the beginning and the members of the control group will receive training three months after receiving the post-test results. It is necessary to be mentions, students are unaware of assignments to study groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Substance abuse intention and behavior, media literacy related to substance abuse..</hc_freetext>
      <i_freetext>Intervention 1: In the intervention group: The educational intervention includes five web based education sessions about substance abuse prevention and substance abuse media literacy. Each session includes 40-45 minutes of training with question and answer methods and group discussion (Chat rooms) will be held with the help of multimedia tools and reminder messages. For example; the first educational session aimed at familiarizing students with Drugs and the consequences of substance abuse, the second session aimed at familiarizing students with substance abuse media literacy skills and 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 be held to correct students' beliefs and attitudes towards substance abuse with the mentioned web based teaching methods and materials. Intervention 2: Control group: (delayed intervention group) who did not receive any educational intervention, but in order to comply with research ethics and commitments to blindness, after receiving the results of three months follow up in the intervention group, all educational interventions will be provided to the control group.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
All data is potentially shareable after unidentified individuals.

When:
6 months after the publication of the article.

To whom:
All researchers who request data access to one of the authors of the article.

Conditions:
For further studies.

Where to obtain:
Vice Chancellor for Research and Technology of Hamadan University of Medical Sciences

How to obtain:
Up to one month.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Majid Barati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of public health, School of public health, Hamadan University of Medical Sciences, in front of Mardoom Park, Shahid Fahmideh Blvd; Hamadan</address>
        <city>Hamadan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6517838736</zip>
        <telephone>+98 81 3838 0090</telephone>
        <email>Barati@umsha.ac.ir</email>
        <affiliation>Hamedan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hanieh Jormand</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Public Health, Faculty of Health, Hamadan University of Medical Sciences, in front of Mardoom Park, Shahid Fahmideh Blvd; Hamadan.</address>
        <city>Hamadan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6517838736</zip>
        <telephone>+98 81 3838 0090</telephone>
        <email>jormand69h@gmail.com</email>
        <affiliation>Hamedan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>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
Being interested in participating in the study</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In the intervention group: The educational intervention includes five web based education sessions about substance abuse prevention and substance abuse media literacy. Each session includes 40-45 minutes of training with question and answer methods and group discussion (Chat rooms) will be held with the help of multimedia tools and reminder messages. For example; the first educational session aimed at familiarizing students with Drugs and the consequences of substance abuse, the second session aimed at familiarizing students with substance abuse media literacy skills and 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 be held to correct students' beliefs and attitudes towards substance abuse with the mentioned web based teaching methods and materials.</i_keyword>
      <i_keyword>Control group: (delayed intervention group) who did not receive any educational intervention, but in order to comply with research ethics and commitments to blindness, after receiving the results of three months follow up in the intervention group, all educational interventions will be provided to the control group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Change of Substance Abuse Attitude Score. Timepoint: Before and three months after the intervention. Method of measurement: Researcher made Questionnaire of substance abuse behavior based on Prototype Willingness Model.</prim_outcome>
      <prim_outcome>Change of Subjective Norms Score. Timepoint: Before and three months after the intervention. Method of measurement: Researcher made Questionnaire of substance abuse behavior based on Prototype Willingness Model.</prim_outcome>
      <prim_outcome>Change of risk Images score. Timepoint: Before and three months after the intervention. Method of measurement: Researcher made Questionnaire of substance abuse behavior based on Prototype Willingness Model.</prim_outcome>
      <prim_outcome>Change of substance abuse behavioral willingness score. Timepoint: Before and three months after the intervention. Method of measurement: Researcher made Questionnaire of substance abuse behavior based on Prototype Willingness Model.</prim_outcome>
      <prim_outcome>Change of Substance Abuse Media Literacy Score. Timepoint: Before and three months after the intervention. Method of measurement: Researcher made questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Change of Substance Abuse Intention Score. Timepoint: Before and three months after the intervention. Method of measurement: Researcher-made questionnaire.</sec_outcome>
      <sec_outcome>Change of substance abuse behavior score. Timepoint: Before and three months after the intervention. Method of measurement: Researcher-made questionnaire.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Hamedan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-12-28</approval_date>
        <contact_name>Vice Chancellor for Technology Research, Hamadan University of Medical Sciences</contact_name>
        <contact_address>Department of public health, School of public health, Hamadan University of Medical Sciences, in front of Mardoom Park, Shahid Fahmideh Blvd; Hamadan Hamadan Hamadan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
