<?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>IRCT20200101045980N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-02-04</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>Development and Effectiveness of cognitive, behavioral and social interventions on smoke use prevention (CIPS) among adolescents (15-19 Years Old): a community-based Mixed method Study</public_title>
      <acronym>CIPS</acronym>
      <scientific_title>Development and Effectiveness of cognitive, behavioral and social interventions on smoke use prevention (CIPS) among adolescents (15-19 Years Old) pirbakran city: a community-based Mixed method Study</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-06-27</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>73</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/44747</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Prevention, Other design features: This study is a community-based study without a control group. All participants receive educational intervention directly and indirectly.</study_design>
      <phase>N/A</phase>
      <hc_freetext>smoking.</hc_freetext>
      <i_freetext>Educational intervention in the form of a city-wide exhibition on the outcomes of smoking, sending educational messages through social networks, drawing competitions on the consequences of smoking and secondhand smoke in schools, designing educational reference websites, holding educational sessions. It will do for some adolescent and parents..</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:
Participants' data file, consent form, codes used in the analysis, data classification system, and statistical analysis plan will provide to the responsible persons if necessary for accuracy of the information and...
The study protocol will publish as a rational model of education to prevent smoking in adolescents 
The results of this study and the clinical trial report will publish in the form of an article.

When:
From the second half of the year 1399

To whom:
Research committees and responsible for the journal to verify the results of the study

Conditions:
- Considering the development of the questionnaire the use of this questionnaire in future studies
- the use of interventions to prevent smoking in adolescents

Where to obtain:
E-mail the Research Committees and the journal responsible for the validity of the study results

How to obtain:
Valid e-mail-related research organizations

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hajar Rezaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>First Floor., The Second Door., Left Hand Beside The Aqueduct., Alley  Hosseinieh., Main Ave., Bagh Abrisham., Abrisham City</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8178963539</zip>
        <telephone>+98 31 3744 2638</telephone>
        <email>h.rezaee@hlth.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hajar Rezaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>First Floor., The Second Door., Left Hand Beside The Aqueduct., Alley  Hosseinieh., Main Ave., Bagh Abrisham., Abrisham City</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8178963539</zip>
        <telephone>+98 31 3744 2638</telephone>
        <email>h.rezaee@hlth.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Residing in Pirbakran city
adolescents 15-19 Years Old</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>19 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Questionnaires are incomplete</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>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Educational intervention in the form of a city-wide exhibition on the outcomes of smoking, sending educational messages through social networks, drawing competitions on the consequences of smoking and secondhand smoke in schools, designing educational reference websites, holding educational sessions. It will do for some adolescent and parents.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Cigarette smoking behavior. Timepoint: Before intervention, one and six months after intervention. Method of measurement: research-made questionnaire.</prim_outcome>
      <prim_outcome>Outcome expectancy in a research-made questionnaire from a Mixed Study. Timepoint: Before intervention, one and six months after intervention. Method of measurement: research-made questionnaire from a Mixed Study.</prim_outcome>
      <prim_outcome>Outcome expectation in a research-made questionnaire from a Mixed Study. Timepoint: Before intervention, one and six months after intervention. Method of measurement: research-made questionnaire from a Mixed Study.</prim_outcome>
      <prim_outcome>Self-regulation in a research-made questionnaire from a Mixed Study. Timepoint: Before intervention, one and six months after intervention. Method of measurement: research-made questionnaire from a Mixed Study.</prim_outcome>
      <prim_outcome>Self-efficacy in a research-made questionnaire from a Mixed Study. Timepoint: Before intervention, one and six months after intervention. Method of measurement: research-made questionnaire from a Mixed Study.</prim_outcome>
      <prim_outcome>Self-esteem in a research-made questionnaire from a Mixed Study. Timepoint: Before intervention, one and six months after intervention. Method of measurement: research-made questionnaire from a Mixed Study.</prim_outcome>
      <prim_outcome>Family Function in a research-made questionnaire from a Mixed Study. Timepoint: Before intervention, one and six months after intervention. Method of measurement: research-made questionnaire from a Mixed Study.</prim_outcome>
      <prim_outcome>School Function in a research-made questionnaire from a Mixed Study. Timepoint: Before intervention, one and six months after intervention. Method of measurement: research-made questionnaire from a Mixed Study.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>Esfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-05-15</approval_date>
        <contact_name>Isfahan University of Medical Sciences</contact_name>
        <contact_address>First Floor., The Second Door., Left Hand Beside The Aqueduct., Alley  Hosseinieh., Main Ave., Bagh Abrisham., Abrisham City Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
