<?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>IRCT20180429039464N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-02-19</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Effect of emotions label training in Autism children</public_title>
      <acronym></acronym>
      <scientific_title>The effect of emotions label training to Autism children with high-function on their Quality of life and Mother-Child Relation</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-12-26</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>5</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/36173</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment, Other design features: This study is done with the single-subject design, according to different sources, the number of samples is between 2-10 and without computational formulas, as well as these types of designs are single-grouped and to study the effect of different education in children Autism has many uses in and out of the country.</study_design>
      <phase>2</phase>
      <hc_freetext>Autism with high-function.</hc_freetext>
      <i_freetext>Lets Face It (LFI) Educational Software Training performance: This software will be taught for each child for 3 hours and 15 hours total. In this way, the software is trained by a Lap Top devise in the presence of child's instructor in an appropriate room, and the score will be recorded after the game is completed.                                                                                                 Emotions label performance: Test will include 3 happy, sadness and nervousness emotion cards and 40 situation cards related to these emotional states and include of 2 steps. At each stage, all children, a child instructor and researcher will be in the room. 1- several emotional situations cards will be placed on the board. Then an emotional card will be given to one of the children in random and will be asked to identify the associated emotional state from the cards on the board. Then the emotions situation cards are replaced and the emotional card will be changed, and the same process will be implemented for the next child.    َ2- In reverse of previous step, emotion cards will place on board and request from child to find the emotional situation related to it. Each step is performed in 3 rounds and each round consist of 40 tests for each child. All emotions label training will be performed within 30 hours. Each child is trained for 6 hours in total..</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 Due to the fact that the current study is a new study within the country, there should be extensive consultation with specialized professors in this field and then decide on the release of related items.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Marzieh Hasanpour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery of Tehran, Mirkhani St, Tohid Square</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733171</zip>
        <telephone>+98 21 6105 4413</telephone>
        <email>m-hasanpour@sina.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Marzieh Hasanpour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery of Tehran, Mirkhani St, Tohid Square</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733171</zip>
        <telephone>+98 21 6105 4413</telephone>
        <email>m-hasanpour@sina.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>having Autism with high-function
be able react to Language instructions
age in 8-12 years
IQ upper than 80
Not having emotions control training
Mother and child desire to participate in intervention
No having vision and hearing problems</inclusion_criteria>
      <agemin>8 years</agemin>
      <agemax>12 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Having moderate autism
History of non-collaboration with a researcher in previous studies
The accompanying illnesses disrupt the normal life situation</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F84.5</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Asperger's syndrome</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Lets Face It (LFI) Educational Software Training performance: This software will be taught for each child for 3 hours and 15 hours total. In this way, the software is trained by a Lap Top devise in the presence of child's instructor in an appropriate room, and the score will be recorded after the game is completed.                                                                                                 Emotions label performance: Test will include 3 happy, sadness and nervousness emotion cards and 40 situation cards related to these emotional states and include of 2 steps. At each stage, all children, a child instructor and researcher will be in the room. 1- several emotional situations cards will be placed on the board. Then an emotional card will be given to one of the children in random and will be asked to identify the associated emotional state from the cards on the board. Then the emotions situation cards are replaced and the emotional card will be changed, and the same process will be implemented for the next child.    َ2- In reverse of previous step, emotion cards will place on board and request from child to find the emotional situation related to it. Each step is performed in 3 rounds and each round consist of 40 tests for each child. All emotions label training will be performed within 30 hours. Each child is trained for 6 hours in total.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Quality of life in  children with High Function Autism. Timepoint: Questionnaire will be measured three, two and one weeks before the test, as well as the first day of the test, two weeks after the start of the test and the final day of the test. Method of measurement: Children's Quality of Life Questionnaire (PedsQl).</prim_outcome>
      <prim_outcome>Mother-child relation in autism children with high-function. Timepoint: Questionnaire will be measured three, two and one weeks before the test, as well as the first day of the test, two weeks after the start of the test and the final day of the test. Method of measurement: Mother-child relation questionnaire (MCRE).</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-08-29</approval_date>
        <contact_name>Ethics Committee of Tehran University of Medical Science</contact_name>
        <contact_address>Faculty of Nursing &amp; Midwifery, East Norsrat(Mirkhani) St, Enghelab St Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
