<?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>IRCT20221222056895N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-06-08</date_registration>
      <primary_sponsor>Qazvin University of Medical Sciences</primary_sponsor>
      <public_title>The effect of educational intervention of planned behavior on traffic behaviors in female students</public_title>
      <acronym></acronym>
      <scientific_title>The effect of evaluating the educational intervention based on the integrated model of stages of preparation for change (SOC) and the theory of planned behavior on traffic behaviors in 12-14 year-old female students</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-06-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>76</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/69476</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Simple random sampling method, one of the schools will be selected as the control group and the other school will be selected as the intervention group. Then a list of 12-14 year old students of each school will be prepared and after complying with the entry and exit criteria using the table of numbers. The members of the control and intervention groups will be randomly selected.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Safe traffic behavior in 12-14-year-old female students of Buin Zahra city.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Face-to-face training 4 sessions of 45 minutes in 4 weeks with questions and answers along with slides and video playback, the educational content is compiled based on the theory of planned behavior. The educational program will include subjects to increase awareness, attitude, intention, behavior and perceived behavioral control and abstract norms. Intervention 2: Control group: no action.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maryam Darzi Ramandi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 16، Blvd  Sardar Soleimani, corner of Imam Hossein Square</address>
        <city>Dansfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3458113594</zip>
        <telephone>028234533629</telephone>
        <email>mmdy6656@gmail.com</email>
        <affiliation>Qazvin University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Hadi Morshidi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Qazvin University of Medical Sciences, Blvd Shahid Bahaner</address>
        <city>Qazvin</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5981134197</zip>
        <telephone>+98 28 3336 9581</telephone>
        <email>hmorshedi@qums.ac.ir</email>
        <affiliation>Qazvin University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The willingness and satisfaction of students and their parents to participate in the study
Being in the first 3 stages of preparation for change (according to the answers given to the algorithm of the stages of change)
Studying in 2022-2023, female students in the age range of 12-14 years
Possession of smart mobile phones by students or their parents to send educational posts or virtual education</inclusion_criteria>
      <agemin>12 years</agemin>
      <agemax>14 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Unwillingness to continue volunteering
Suffering from physical and mental disorders and diseases that somehow prevent proper participation in the study (confirmed report by a doctor)
Absence of more than 2 sessions in the training class</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>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Face-to-face training 4 sessions of 45 minutes in 4 weeks with questions and answers along with slides and video playback, the educational content is compiled based on the theory of planned behavior. The educational program will include subjects to increase awareness, attitude, intention, behavior and perceived behavioral control and abstract norms.</i_keyword>
      <i_keyword>Control group: no action</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Consciousness. Timepoint: Before the intervention, one month after the intervention. Method of measurement: Questionnaire.</prim_outcome>
      <prim_outcome>Attitude. Timepoint: Before the intervention, one month after the intervention. Method of measurement: Questionnaire.</prim_outcome>
      <prim_outcome>Perceived behavioral control. Timepoint: Before the intervention, one month after the intervention. Method of measurement: Questionnaire.</prim_outcome>
      <prim_outcome>Behavioral intention. Timepoint: Before the intervention, one month after the intervention. Method of measurement: Questionnaire.</prim_outcome>
      <prim_outcome>Stages of behavior change. Timepoint: Before the intervention, one month after the intervention. Method of measurement: Questionnaire.</prim_outcome>
      <prim_outcome>Safe traffic behavior. Timepoint: Before the intervention, one month after the intervention. Method of measurement: Questionnaire.</prim_outcome>
      <prim_outcome>Abstract norm. Timepoint: Before the intervention, one month after the intervention. Method of measurement: Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Age. Timepoint: Before the intervention, one month after the intervention. Method of measurement: Questionnaire.</sec_outcome>
      <sec_outcome>Grade. Timepoint: Before the intervention, one month after the intervention. Method of measurement: Questionnaire.</sec_outcome>
      <sec_outcome>Parents' occupation. Timepoint: Before the intervention, one month after the intervention. Method of measurement: Questionnaire.</sec_outcome>
      <sec_outcome>Parents' education. Timepoint: Before the intervention, one month after the intervention. Method of measurement: Questionnaire.</sec_outcome>
      <sec_outcome>The economic situation. Timepoint: Before the intervention, one month after the intervention. Method of measurement: Questionnaire.</sec_outcome>
      <sec_outcome>A history of accidents leading to injuries in the family, relatives and friends. Timepoint: Before the intervention, one month after the intervention. Method of measurement: Questionnaire.</sec_outcome>
      <sec_outcome>A history of accidents leading to death in the family, relatives and friends. Timepoint: Before the intervention, one month after the intervention. Method of measurement: 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>Qazvin University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-03-18</approval_date>
        <contact_name>Ethics Committee of Qazvin University of Medical Sciences</contact_name>
        <contact_address>Qazvin University of Medical Sciences, BIvd Shahid Bahonar Qazvin Qazvin Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
