<?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>IRCT20180813040780N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-10-13</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>Effectiveness of an interventional program on aggressive behaviors in adolescents aged 13 to 15</public_title>
      <acronym></acronym>
      <scientific_title>The effect of training based on planned pattern of behavior on aggression in adolescents aged 13-15</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/33410</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Education/Guidance, Other design features: In this study, a model of planned behavior will be used to study the components of a comprehensive school aggression prevention approach, Randomization description: Two boys 'state schools will be available in terms of roughly similar terms (geographic location, student numbers and teachers' status). After explaining the goal to the parents and obtaining the written consent of the researcher from their students and their parents, two schools will be randomly assigned to two intervention and control groups through throwing coins (control group milk and intervention group line).</study_design>
      <phase>N/A</phase>
      <hc_freetext>Aggression.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Educational sessions based on the results obtained from the completion of the questionnaire of the structured models of planned behavior in the intervention group, educational program based on the pattern of planned behavior in the intervention group, group sessions, lectures and group discussions, and in groups of 10, educational booklet. Intervention 2: Control group: This group does not receive any 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>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 After the end of the study, the decision will be made according to the results of the study.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohaddeseh Salari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>University of Ave., Ph.D. Course, Avicenna Street, Faculty of Nursing and Midwifery9</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9137913199</zip>
        <telephone>+98 51 3859 1511</telephone>
        <email>Salaridm951@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohadese Salari dehreis</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>University of Nursing, Ph.D. Ave., Avicenna Street, Faculty of Nursing and Midwifery9</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9137913199</zip>
        <telephone>+98 51 3859 1511</telephone>
        <email>salaridm951@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Conscious Satisfaction of Students and Parents with Participation in Intervention
Living with parents
The ability to communicate verbally
Earn score of 77/8 or more from bass and perry aggression questionnaire
The absence of acute or chronic physical or mental illness
Ages ranging from 15 to 13 years old</inclusion_criteria>
      <agemin>13 years</agemin>
      <agemax>15 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Presence of acute or chronic physical or mental illness confirmed by a doctor</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F91.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Conduct disorder, adolescent-onset type</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Educational sessions based on the results obtained from the completion of the questionnaire of the structured models of planned behavior in the intervention group, educational program based on the pattern of planned behavior in the intervention group, group sessions, lectures and group discussions, and in groups of 10, educational booklet</i_keyword>
      <i_keyword>Control group: This group does not receive any intervention.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Earn at least a score of 77.8 from the Bass &amp; Perry Aggression Questionnaire. Timepoint: Before starting the study, immediately and one month after the intervention. Method of measurement: Bass &amp; Perry Aggression Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Verbal aggression. Timepoint: Before the intervention, immediately after the intervention, one month after the intervention. Method of measurement: Bass &amp; Perry Aggression Questionnaire.</sec_outcome>
      <sec_outcome>Physical aggression. Timepoint: Before the intervention, immediately after the intervention, one month after the intervention. Method of measurement: Bass &amp; Perry Aggression Questionnaire.</sec_outcome>
      <sec_outcome>Anger. Timepoint: Before the intervention, immediately after the intervention, one month after the intervention. Method of measurement: Bass &amp; Perry Aggression Questionnaire.</sec_outcome>
      <sec_outcome>Hostility. Timepoint: Before the intervention, immediately after the intervention, one month after the intervention. Method of measurement: Bass &amp; Perry Aggression Questionnaire.</sec_outcome>
      <sec_outcome>Awareness. Timepoint: Before the intervention, immediately after the intervention, one month after the intervention. Method of measurement: Structure Theory of Planned Behavior.</sec_outcome>
      <sec_outcome>Attitude. Timepoint: Before the intervention, immediately after the intervention, one month after the intervention. Method of measurement: Structure Theory of Planned Behavior.</sec_outcome>
      <sec_outcome>Abstract norms. Timepoint: re the intervention, immediately after the intervention, one month after the intervention. Method of measurement: Structure Theory of Planned Behavior.</sec_outcome>
      <sec_outcome>Intent. Timepoint: Before the intervention, immediately after the intervention, one month after the intervention. Method of measurement: Structure Theory of Planned Behavior.</sec_outcome>
      <sec_outcome>Behavior. Timepoint: Before the intervention, immediately after the intervention, one month after the intervention. Method of measurement: Structure Theory of Planned Behavior.</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>2018-08-23</approval_date>
        <contact_name>The Ethics Committee of Mashhad University of Medical Sciences</contact_name>
        <contact_address>Faculty of Nursing and Midwifery, Ibn Sina Avenue, Ph.D., Mashhad, Iran Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
