<?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>IRCT20231022059801N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-12-14</date_registration>
      <primary_sponsor>Bu Alisina University</primary_sponsor>
      <public_title>The Effectiveness of Empathy Training on Aggression, Adaptation and Social Responsibility of Preschool Children</public_title>
      <acronym></acronym>
      <scientific_title>The Effectiveness of Empathy Training on Aggression, Adaptation and Social Responsibility of Preschool Children</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-04-09</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/73416</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Education/Guidance, Randomization description: After selecting the sample using the table of random numbers, the subjects were randomly replaced in the experimental and control groups.A table of random numbers is a collection of numbers that are generated completely randomly without a specific pattern or order and are presented as a table. In order to use the table of random numbers, the researcher must first determine the direction of reading the numbers in the table (for example, up, down, left or right, in this study left to right was chosen). The second assumption of the researcher is to consider numbers for different groups (even numbers were considered for the intervention group and odd numbers were considered for the control group). Then the researcher randomly selected one of the numbers and moved in one of the predetermined directions (from left to right in this study) and recorded the numbers and allocated them to the intervention and control groups, and this process continued until all the sample subject were selected.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Aggression.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: intervention group (empathy training): To teach children empathy, empathy training programs (Jan Bozorgi, Noori and Agah Haris, 2014), which are suitable for preschool and elementary children. The program consists of four steps as follows: Step One: Introduction to physiological feelings such as hunger, thirst, fatigue, cold, heat. Step Two: Introduction to psychological feelings such as sadness, anger, happiness. Step Three: Focusing on the similarity and difference of your feeling with another and emphasizing your feelings. Step Four: Strengthening empathy responses. The intervention program was conducted by the researcher in the pre -school training classes. The intervention took place in eight sessions one hour. Intervention 2: Control group: The control group did not receive any intervention in the present study and received the usual daily training during the intervention period in experimental group.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Abolghasem Yaghoobi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hamedan, Chaharbagh Shahid Mostafa Ahmadi Roshan, Boali Sina University</address>
        <city>Hamedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۳۸۶۹۵-۶۵۱۷۸</zip>
        <telephone>+98 81 3284 5541</telephone>
        <email>Yaghoobi@basu.ac.ir</email>
        <affiliation>Bu-Ali Sina University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Abolghasem Yaghoobi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hamedan, Chaharbagh Shahid Mostafa Ahmadi Roshan, Boali Sina University</address>
        <city>Hamedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۳۸۶۹۵-۶۵۱۷۸</zip>
        <telephone>0098 81 3284541</telephone>
        <email>Yaghoobi@basu.ac.ir</email>
        <affiliation>Bu-Ali Sina University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Minimum age is 5 years old
Maximum age is 6 years old</inclusion_criteria>
      <agemin>5 years</agemin>
      <agemax>6 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having psychological disorders</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: intervention group (empathy training): To teach children empathy, empathy training programs (Jan Bozorgi, Noori and Agah Haris, 2014), which are suitable for preschool and elementary children. The program consists of four steps as follows: Step One: Introduction to physiological feelings such as hunger, thirst, fatigue, cold, heat. Step Two: Introduction to psychological feelings such as sadness, anger, happiness. Step Three: Focusing on the similarity and difference of your feeling with another and emphasizing your feelings. Step Four: Strengthening empathy responses. The intervention program was conducted by the researcher in the pre -school training classes. The intervention took place in eight sessions one hour.</i_keyword>
      <i_keyword>Control group: The control group did not receive any intervention in the present study and received the usual daily training during the intervention period in experimental group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Aggression. Timepoint: Pre-test stage and post-test stage - one month interval. Method of measurement: Measure: Questionnaire.</prim_outcome>
      <prim_outcome>Adaptation. Timepoint: Pre-test stage and post-test stage - one month interval. Method of measurement: Measure: Questionnaire.</prim_outcome>
      <prim_outcome>Social Responsibility. Timepoint: Pre-test stage and post-test stage - one month interval. Method of measurement: Measure: Questionnaire.</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>Bu Alisina University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-07-10</approval_date>
        <contact_name>Ethics committee of Bu-Ali Sina University</contact_name>
        <contact_address>Chaharbagh Shahid Mostafa Ahmadi Roshan, Bu-Ali Sina University, Hamedan Hamedan Hamadan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
