<?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>IRCT20171016036814N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-02-11</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>The effect of smoking  prevention program on smoking refusal  self-efficacy</public_title>
      <acronym></acronym>
      <scientific_title>Study of The effect of educational smoking  prevention program on  smoking refusal self-efficacy of senior high school females</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-02-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>27</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/28217</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Randomization: simple, unit of randomization: school, method: of the two schools that are randomly selected, one will assigned to intervention and the other will be taken as control. this procedure will be done by Excel program. Concealment is not applicable to the present study.</study_design>
      <phase>N/A</phase>
      <hc_freetext>prevention of smoking in adolescents.</hc_freetext>
      <i_freetext>Intervention 1: The intervention group: the intervention group will take part in five 90 minute smoking preventive educational sessions, held in their schools and within five consecutive weeks. Instruction methods include lecture, group discussion, showing video, pamphlets, and role modelling with focus on short- and long-term harmful effect of smoking, as well as stress management, assertiveness, effective communication, and decision-making skills. The eight following activities are implemented in each session: (1) “Sharing experience/brainstorming” (discussion and brainstorm participant’s self-knowledge and self-experience about smoking), (2) “Knowledge about smoking” (ingredients of cigarettes, short-term effects of smoking on body and health, long-term effects of smoking on body and health, increasing awareness about consequence of smoking to passive smokers or second-hand smokers and understanding of myth and fact about smoking), (3) “Stress management for teenager” (stress management and lesson about stress, emotion experience, psychological stressor, strategies to handle stress situation, created positive mood and reduced stress in daily), (4) “Assertive communication and smoking refusal skill” (Training and role play to refuse cigarette offered by watching the video), enhancing awareness and motivate to refuse cigarette), (5) “Decision making skills” (Knowledge to make decision related to smoking behavior and practice decision making skill in group), .6)Role playing in situation that needs to say no. Intervention 2: Control group: the control group receive no intervention.</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 except for identity information could be available to researchers

When:
six months after publishing the research paper

To whom:
Researchers

Conditions:
research affairs

Where to obtain:
Dr Fatemeh Heshmati Nabavi, Scientific responsible of the research project

How to obtain:
A research proposal which is approved by a formal organization and is confirmed by Mashhad University of Medical Sciences and then correspondence with Dr Fatemeh Heshmati Nabavi, Scientific responsible of the research project

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>zienab Rafiee</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>NO. 98 ,emamat Ave,</address>
        <city>mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9188615381</zip>
        <telephone>+98 51 3608 3416</telephone>
        <email>rafieez2@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>fatemeh heshmati nabavi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ebn sina Ave.nursig and midwifery univercity</address>
        <city>mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9138813944</zip>
        <telephone>+98 51 3859 1511</telephone>
        <email>HeshmatiNf2@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Female
Had willingness to participate
Had permission from the parents or guardians to join in the program
Non-smoker</inclusion_criteria>
      <agemin>16 years</agemin>
      <agemax>16 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>smoker
Students with depression condition</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>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The intervention group: the intervention group will take part in five 90 minute smoking preventive educational sessions, held in their schools and within five consecutive weeks. Instruction methods include lecture, group discussion, showing video, pamphlets, and role modelling with focus on short- and long-term harmful effect of smoking, as well as stress management, assertiveness, effective communication, and decision-making skills. The eight following activities are implemented in each session: (1) “Sharing experience/brainstorming” (discussion and brainstorm participant’s self-knowledge and self-experience about smoking), (2) “Knowledge about smoking” (ingredients of cigarettes, short-term effects of smoking on body and health, long-term effects of smoking on body and health, increasing awareness about consequence of smoking to passive smokers or second-hand smokers and understanding of myth and fact about smoking), (3) “Stress management for teenager” (stress management and lesson about stress, emotion experience, psychological stressor, strategies to handle stress situation, created positive mood and reduced stress in daily), (4) “Assertive communication and smoking refusal skill” (Training and role play to refuse cigarette offered by watching the video), enhancing awareness and motivate to refuse cigarette), (5) “Decision making skills” (Knowledge to make decision related to smoking behavior and practice decision making skill in group), .6)Role playing in situation that needs to say no.</i_keyword>
      <i_keyword>Control group: the control group receive no intervention</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Smoking refusal self-efficacy. Timepoint: At the beginning of study, Four weeks after completion of intervention. Method of measurement: The self-efficacy scale for adolescents smoking by lawrence.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>. Timepoint: . Method of measurement: .</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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-10-07</approval_date>
        <contact_name>Ethics committee of Mashhad  University of Medical Sciences</contact_name>
        <contact_address>No. 18, university Ave., mashhad Town Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
