<?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>IRCT20200923048817N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-10-26</date_registration>
      <primary_sponsor>Jeeroft University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation the effect of educational program based on Self-regulation Theory on prevention of alcohol use among Secondery high school male students</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation the effect of educational program based on Self-regulation Theory on prevention of alcohol use among Secondery high school male students in southern area of Kerman</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-12-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>420</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/51213</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Other design features: Intervention based on the structures of self-regulatory theory, Randomization description: The statistical population includes second grade high school male students in 7 cities under the auspices of Jiroft University of Medical Sciences (south of Kerman) in the academic year 2010-2011. The sampling method is cluster-multi-stage sampling. Sampling is that 2 high schools from each city and 1 class from each high school are randomly selected. A total of 14 classes are randomly selected. After that, in each high school, one class is considered as the experimental group and one class as the control group, and finally 7 classes are divided as the experimental group and 7 classes as the control group, Blinding description: Study participants were unaware of the allocation in groups after consenting to participate in the study and knowledge of the purpose of the study. Data collectors and those evaluating the outcome were also unaware of the allocation of students in the groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>alcohol use.</hc_freetext>
      <i_freetext>Intervention 1: The intervention is such that at least 6 training sessions (45 to 60 minutes each session according to the participants) are used during 10 weeks to prevent alcohol consumption using self-regulatory theory. The first session to increase knowledge and skills with lectures and questions and answers, the second session with increasing people's self-confidence through self-efficacy and performing behavioral inhibition behavior skills from short educational videos, setting up an exhibition, the third session on effective memory, which includes the ability Store and recall useful information to solve the problem. That can be activated in people with the ability to save and remember by reporting and working on a specific project or content. The fourth session is accompanied by an internal dialogue so that by expressing the inner feelings and emotions of the participants, as much as possible, people can be led to their situation, where they are and where they want to go. The fifth session is about motivational assessment: the person tries to create a hypothetical future by emotionally and motivationally evaluating past events in effective memory. By evaluating the desirable situation of people in the past and by remembering them, a bright future in people's lives can be imagined. Sixth session, including behavioral reconstruction (behavioral synthesis), should be done by analyzing or separating the past behavioral structure and their hierarchy and rearranging the past behavior and creating new behaviors with a new structure and new sequence. Encouraged in people. Intervention 2: Control group: No intervention is made.</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 Since the study has not started yet, I have not made a decision yet</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ehsan Movahed</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Pasdaran</address>
        <city>Jiroft</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7618746864</zip>
        <telephone>+98 34 4331 7802</telephone>
        <email>ehsanmovahed89@yahoo.com</email>
        <affiliation>Jeeroft University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ehsan Movahed</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>pasdaran</address>
        <city>Jiroft</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7618746864</zip>
        <telephone>+98 34 4331 7802</telephone>
        <email>ehsanmovahed89@yahoo.com</email>
        <affiliation>Jeeroft University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Second grade of high school
boy
natives of the region</inclusion_criteria>
      <agemin>16 years</agemin>
      <agemax>17 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Lack of cooperation to participate in the study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F10.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Alcohol abuse</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 is such that at least 6 training sessions (45 to 60 minutes each session according to the participants) are used during 10 weeks to prevent alcohol consumption using self-regulatory theory. The first session to increase knowledge and skills with lectures and questions and answers, the second session with increasing people's self-confidence through self-efficacy and performing behavioral inhibition behavior skills from short educational videos, setting up an exhibition, the third session on effective memory, which includes the ability Store and recall useful information to solve the problem. That can be activated in people with the ability to save and remember by reporting and working on a specific project or content. The fourth session is accompanied by an internal dialogue so that by expressing the inner feelings and emotions of the participants, as much as possible, people can be led to their situation, where they are and where they want to go. The fifth session is about motivational assessment: the person tries to create a hypothetical future by emotionally and motivationally evaluating past events in effective memory. By evaluating the desirable situation of people in the past and by remembering them, a bright future in people's lives can be imagined. Sixth session, including behavioral reconstruction (behavioral synthesis), should be done by analyzing or separating the past behavioral structure and their hierarchy and rearranging the past behavior and creating new behaviors with a new structure and new sequence. Encouraged in people.</i_keyword>
      <i_keyword>Control group: No intervention is made</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Behavioral inhibition. Timepoint: Before and after the intervention. Method of measurement: researcher-made questionnaire (behavioral inhibition).</prim_outcome>
      <prim_outcome>Effective memory. Timepoint: Before and after the intervention. Method of measurement: Researcher-made questionnaire (effective memory).</prim_outcome>
      <prim_outcome>Internal dialogue. Timepoint: Before and after the intervention. Method of measurement: Researcher-made questionnaire (internal conversation).</prim_outcome>
      <prim_outcome>Motivational assessment;. Timepoint: Before and after the intervention. Method of measurement: Researcher-made questionnaire (motivational assessment).</prim_outcome>
      <prim_outcome>Behavioral reconstruction. Timepoint: Before and after the intervention. Method of measurement: Researcher-made questionnaire (behavioral reconstruction).</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>Jeeroft University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-02-20</approval_date>
        <contact_name>Ethics Committee of Jiroft University of Medical Sciences</contact_name>
        <contact_address>Pasdaran Blvd Jiroft Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
