<?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>IRCT20200223046599N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-04-18</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Evaluation of emotion regulation training in attention deficit disorder - youth hyperactivity</public_title>
      <acronym></acronym>
      <scientific_title>Effectiveness of Emotional Regulation Training in Cognitive Disorders and Emotional Failure and General Health of Students with Attention Deficit / Hyperactivity Disorder in Secondary School</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-11-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>240</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/46819</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Among the dual education districts of Urmia, District 1 was selected based on coin toss. Among the second grade high schools in District One, two boys 'schools and two girls' schools were selected by lottery, and in each school, one class from each second grade high school with individual number (even and odd classes) were chosen.</study_design>
      <phase>N/A</phase>
      <hc_freetext>attention deficit hyperactivity disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Intervention group: Group of 15 selected for treatment, and treatment protocol based on Gross model will be administered in eight sessions for experimental group. The first session: Introducing the members of the group to each other and starting the relationship between the group leader and the members and doing exercises with the aim of getting to know each other. Short-term and long-term emotions of the third session: 1-Self-assessment with the aim of recognizing one's emotional experiences 2-Self-assessment with the aim of identifying the level of emotional vulnerability in the individual 3 Preventing social isolation and avoiding b) Teaching problem-solving strategies c) Teaching interpersonal skills (Dialogue, Expression, and Conflict Resolution)Session 5: 1) Stop the mental rumination and worry 2) Learn to pay attention to the sixth session: 1) Identify the wrong evaluations and their effects on emotional states 2) Teach the strategy of re-evaluation of the seventh session: Preventing and examining its emotional consequences 2) Confrontation 3) Emotional expression training 4) Behavior modification by changing environmental enhancers 5) Emotional evacuation training, relaxation and reverse action of the eighth session: 1) Evaluating the achievement of individual and group goals 2) Application of skills learned in natural environments outside the meeting 3) Investigating and removing barriers to homework. Intervention 2: Control group: Group of 15 people who will not receive any treatment.</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 The community is a statistic related to the Department of Education and publication is at the discretion of the Department.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sakineh Behravan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>West Azerbaijan Province, Urmia, Department of Education, General Directorate of Health and Wellness</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5719198853</zip>
        <telephone>00983676790</telephone>
        <email>sakinehbehravan@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sakineh Behravan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>West Azerbaijan Province, Urmia, Department of Education, General Directorate of Health and Wellness</address>
        <city>urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5719198853</zip>
        <telephone>00983676791</telephone>
        <email>sakinehbehravan@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having clinical symptoms of attention deficit hyperactivity disorder
Having cognitive impairment
Cognitive failure
Study in the second year of high school</inclusion_criteria>
      <agemin>16 years</agemin>
      <agemax>18 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Studying in high school in high school
Lack of attention deficit disorder - and hyperactivity
Out of age 16 and 18 years</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F90.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>تظاهرات بالینی مرکب(هم تکانشی و هم بی توجهی)</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: Intervention group: Group of 15 selected for treatment, and treatment protocol based on Gross model will be administered in eight sessions for experimental group. The first session: Introducing the members of the group to each other and starting the relationship between the group leader and the members and doing exercises with the aim of getting to know each other. Short-term and long-term emotions of the third session: 1-Self-assessment with the aim of recognizing one's emotional experiences 2-Self-assessment with the aim of identifying the level of emotional vulnerability in the individual 3 Preventing social isolation and avoiding b) Teaching problem-solving strategies c) Teaching interpersonal skills (Dialogue, Expression, and Conflict Resolution)Session 5: 1) Stop the mental rumination and worry 2) Learn to pay attention to the sixth session: 1) Identify the wrong evaluations and their effects on emotional states 2) Teach the strategy of re-evaluation of the seventh session: Preventing and examining its emotional consequences 2) Confrontation 3) Emotional expression training 4) Behavior modification by changing environmental enhancers 5) Emotional evacuation training, relaxation and reverse action of the eighth session: 1) Evaluating the achievement of individual and group goals 2) Application of skills learned in natural environments outside the meeting 3) Investigating and removing barriers to homework.</i_keyword>
      <i_keyword>Control group: Group of 15 people who will not receive any treatment.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Attention deficit hyperactivity disorder condition. Timepoint: Will be done from 20/11/19 to15/12/19 before intervention and two weeks after intervention. Method of measurement: Through the questionnaire.</prim_outcome>
      <prim_outcome>Cognitive failure. Timepoint: Will be done from 20/11/19 to15/12/19 before intervention and two. Method of measurement: Through the questionnaire.</prim_outcome>
      <prim_outcome>Emotional failure. Timepoint: Will be done from 20/11/19 to15/12/19 before intervention and two. Method of measurement: Through the questionnaire.</prim_outcome>
      <prim_outcome>General health. Timepoint: Will be done from 20/11/19 to15/12/19 before intervention and two. Method of measurement: Through the 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>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-12-06</approval_date>
        <contact_name>Ethics committee of Hormozgan University of Medical Sciences</contact_name>
        <contact_address>Hormozgan University of Medical Sciences, Shahid Chamran Boulevard, Bandar Abbas, Irani Bandaabas Hormozgan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
