<?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>IRCT20190703044082N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-06-06</date_registration>
      <primary_sponsor>Hamedan University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the effect of traditional and computerized emotional facial education training on children with autism</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of traditional face computer training on children with autism on mother-child relationships and parental competence in autism centers</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-06-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/42697</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Parallel block random allocation will be used to randomly allocate high and moderate performance autistic children to traditional, computerized and control groups. Write the names of the three groups on a piece of paper and randomize them and specify the order of sampling.For random allocation of samples in three traditional, computerized and control groups, 20 blocks of 6 blocks will be used as random block allocation. Thus, the letter A for the computer group, the letter B for the traditional group and the letter C for the control group  will be considered.On the pieces of paper, WILL write the blocks and put them in the envelope and we will randomly remove the the pieces of paper. next according to the probable order of sampling will start, Blinding description: The person who completes the questionnaires will be blinded by the allocation of individuals in the intervention groups.In addition, the person who analyzes the data will be blinded to the allocation of individuals to the groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Autism.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group( traditional method) : In this method, the children will be trained by the researcher with the mother in 10 sessions of 30 to 60 minutes.It will be used To train 40 different images related to 4 positions of happiness, sadness, anger and fear (From each mode, 10 images) and The child should, with the help of the researcher and the mother, select the right emotional state appropriate to the target's face.All faces are a picture of a boy in size A5 and colorful.Images are displayed individually and from the front view to the child and without any explanation, the child is asked to select any image appropriate to the target's face. Every time they recognize a picture correctly, they will be encouraged by the mother and the researcher, and the next image will be shown. But in the event of a wrong answer, the researcher or the mother reminds you to "try again" and an indirect reference to the correct answer And if the wrong answer is repeated, direct reference is given to the correct answer And this process will be repeated until the participant gives the correct answer.In each session, four pictures (one image of each emotional state) are taught to the child. The mother is present with the researcher and learns how to train. Whenever a mother expresses her willingness to educate the child, the researcher assigns one or more of the images to her And supervises the child's education by the mother so that the training is done correctly. In this case, the researcher will express it if it is necessary to provide a point. At the end of each training session, if the mothers have ambiguity and questions about the trained images in each session, the researcher will respond to them. Intervention 2: Intervention group (computer method): To teach computer method, the participants will be trained by a researcher with the mother with LFI software in 30 to 60 minutes during 10 sessions.In this method, the researcher teaches Let's Face It educational software (6 game stages) for each of the participants independently, using a laptop device in each session. Each child will independently play all the steps of the software with the help and guidance of a researcher.This software consists of 8 links, the logo of each link is the face of an animal that enters the game by clicking on it. game links include: Lion, Stork, Zebra, Monkey, Rhinoceros, Crocodile, Elephant and Blue Horse, all of which will improve the understanding and recognition of emotions in all its dimensions.Each stage of the game has many advantages that are set to encourage the child to play more and more.At the end of all games, each participant's score will be added and the child's score will be estimated. At the end of each training session, if the mothers have any ambiguities or questions about the images taught in each session, the researcher will answer them. Intervention 3: Control group: The control group receives routine training.</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 No information available</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fatemeh Mohammadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Beginning of Ayatollah Kashani Boulevard, Hamadan University of Medical Sciences and Health Services</address>
        <city>Hamedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6517838698</zip>
        <telephone>+98 81 3334 5678</telephone>
        <email>F-mohammadi@umsha.ac.ir</email>
        <affiliation>Hamedan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fatemeh Mohammadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Beginning of Ayatollah Kashani Boulevard, Hamadan University of Medical Sciences and Health Services</address>
        <city>Hamedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6517838698</zip>
        <telephone>+98 81 3334 5678</telephone>
        <email>F-mohammadi@umsha.ac.ir</email>
        <affiliation>Hamedan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Based on the DSM-IV Manual of Psychiatric Disorders, according to a psychiatrist's assessment of a child and adolescent child with high and moderate performance  autism
In the pediatric medical records, they received 22 scores from the instructor or 19 scores from the mother based on the Autism Scale questionnaire
Has the ability to understand and practice experimental exercises
Lack of mental retardation or other known physical, cognitive, evolutionary-disease
Lack of visual impairment
Their mothers are satisfied with the child's participation in the study
Their mothers are able to participate in the child's education and participate in the study
Ability to work with computers at elementary level</inclusion_criteria>
      <agemin>6 years</agemin>
      <agemax>15 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Absence of children in three sessions or more during training</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>f84</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>childhood autism</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group( traditional method) : In this method, the children will be trained by the researcher with the mother in 10 sessions of 30 to 60 minutes.It will be used To train 40 different images related to 4 positions of happiness, sadness, anger and fear (From each mode, 10 images) and The child should, with the help of the researcher and the mother, select the right emotional state appropriate to the target's face.All faces are a picture of a boy in size A5 and colorful.Images are displayed individually and from the front view to the child and without any explanation, the child is asked to select any image appropriate to the target's face. Every time they recognize a picture correctly, they will be encouraged by the mother and the researcher, and the next image will be shown. But in the event of a wrong answer, the researcher or the mother reminds you to "try again" and an indirect reference to the correct answer And if the wrong answer is repeated, direct reference is given to the correct answer And this process will be repeated until the participant gives the correct answer.In each session, four pictures (one image of each emotional state) are taught to the child. The mother is present with the researcher and learns how to train. Whenever a mother expresses her willingness to educate the child, the researcher assigns one or more of the images to her And supervises the child's education by the mother so that the training is done correctly. In this case, the researcher will express it if it is necessary to provide a point. At the end of each training session, if the mothers have ambiguity and questions about the trained images in each session, the researcher will respond to them.</i_keyword>
      <i_keyword>Intervention group (computer method): To teach computer method, the participants will be trained by a researcher with the mother with LFI software in 30 to 60 minutes during 10 sessions.In this method, the researcher teaches Let's Face It educational software (6 game stages) for each of the participants independently, using a laptop device in each session. Each child will independently play all the steps of the software with the help and guidance of a researcher.This software consists of 8 links, the logo of each link is the face of an animal that enters the game by clicking on it. game links include: Lion, Stork, Zebra, Monkey, Rhinoceros, Crocodile, Elephant and Blue Horse, all of which will improve the understanding and recognition of emotions in all its dimensions.Each stage of the game has many advantages that are set to encourage the child to play more and more.At the end of all games, each participant's score will be added and the child's score will be estimated. At the end of each training session, if the mothers have any ambiguities or questions about the images taught in each session, the researcher will answer them.</i_keyword>
      <i_keyword>Control group: The control group receives routine training</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Maternal-child relationships with autism 6-12 years in Ross questionnaire. Timepoint: 1 day before training and 1 and 7 days after training. Method of measurement: Ross questionnaire.</prim_outcome>
      <prim_outcome>Parental Competence in Parents of Autistic Children in (PCS)questionnaire. Timepoint: 1 day before training and 1 and 7 days after training. Method of measurement: (PCS)questionnaire.</prim_outcome>
      <prim_outcome>Emotional face identification in children with autism. Timepoint: 1 day before training and 1 and 7 days after training. Method of measurement: Modified Benton Face Recognition Scale.</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>Hamedan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-07-16</approval_date>
        <contact_name>Research ethics committee of Hamedan University of Medical Sciences</contact_name>
        <contact_address>Beginning of Khajeh Rashid Blvd, Hamedan University of Medical Sciences Hamedan Hamadan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
