<?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>IRCT20210619051618N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-11-01</date_registration>
      <primary_sponsor>Cognitive Sciences and Technologies Council</primary_sponsor>
      <public_title>Comparison of effectiveness of cognitive rehabilitation based on remediation and compensation strategies on theory of mind and executive function in preschool children with autism</public_title>
      <acronym></acronym>
      <scientific_title>Social cognition dysfunction in children with high functioning autism disorder: evaluation, developing program based on remediation and compensation strategies and study on its effectiveness on theory of mind ability and executive function</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-10-24</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/57924</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: participant who met the inclusion and exclusion criteria were randomly divided into three groups of first intervention, second intervention and control by online generating random numbers (calculator.net/random-number-generator). In the random numbers program, the numbers range was set from 1 to 60, and by choosing no duplicates, we request the production of three sets of random numbers, which are assigned to each group according to visit number of the people. This allocation is concealed from researchers and participant, Blinding description: Not blinded.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Autism.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1 : program based on remediation strategies. The treatment protocol consists of 18 one-hour sessions. The theory of mind training package based on the basics of mind theory and  is designed according to the evolutionary and multidimensional approach of "theory of mind". training package is designed according to the evolutionary and multidimensional approach of "theory of mind". Intervention 2: Intervention group 2 : program based on compensation strategies. Rehabilitation package for executive functions in children with autism: In this program, based on theories, the basis of executive functions and cognitive rehabilitation,  inhibitory control, working memory and cognitive flexibility are targeted.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
data file, study protocol, informed consent form and clinical study reports after unidentifiable people is shareable

When:
The beginning of the access period is 1 year after the publication of the results.

To whom:
data of this research will be available only for researchers that working in universities.

Conditions:
Use of the data is allowed only for review articles.

Where to obtain:
fateme abadi
 Mobile number: 00 98 9123138621
Email:psy.abadi@gmail.com
Address:Phase 4 of Pardis City, Tehran, Iran

How to obtain:
Researchers who want to access the data must get a letter from the university at their place of work and send to the responsible person's email address, then the data will be available in less than 1 month.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Alireza Moradi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Phase 4 of Pardis City, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1658344575</zip>
        <telephone>+98 21 7629 1130</telephone>
        <email>moradi90@yahoo.com</email>
        <affiliation>Institute for Cognitive Science Studies</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fateme Abadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Phase 4 of Pardis City, Tehran, Iran</address>
        <city>tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1658344575</zip>
        <telephone>+98 21 7629 1130</telephone>
        <email>psy.abadi@gmail.com</email>
        <affiliation>Institute for Cognitive Science Studies</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>used participants between the ages of 4 and 7 years with autism spectrum disorder
diagnosis of autism based on DSM-V criteria
IQ above 80 according to Wechsler 3
don't poor vision or hearing based on the child's record
Parent consent to participate in the study</inclusion_criteria>
      <agemin>4 years</agemin>
      <agemax>7 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>history of seizures
Receive simultaneous study
Reluctance to continue attending meetings</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F84.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Autistic disorder</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>N/A</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1 : program based on remediation strategies. The treatment protocol consists of 18 one-hour sessions. The theory of mind training package based on the basics of mind theory and  is designed according to the evolutionary and multidimensional approach of "theory of mind". training package is designed according to the evolutionary and multidimensional approach of "theory of mind".</i_keyword>
      <i_keyword>Intervention group 2 : program based on compensation strategies. Rehabilitation package for executive functions in children with autism: In this program, based on theories, the basis of executive functions and cognitive rehabilitation,  inhibitory control, working memory and cognitive flexibility are targeted.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Mind Theory score, which is measured through the Mind Theory Scale, Stirman et al.'S Mind Theory, and Mind Theory Stories questionnaires. Timepoint: Components of theory of mind   at the beginning of the study before the intervention and will be measured three months after the start of the study after the intervention and one month after the last intervention. Method of measurement: theory of mind is measured through the theory of mind Scale Questionnaire, the theory of mind Test, theory of mind stories.</prim_outcome>
      <prim_outcome>Executive functions score, which is measured through the dimond's shape span, Missing scan test, shape school, day and night stroop,TRAIL-P. Timepoint: executive functions at the beginning of the study before the intervention and will be measured three months after the start of the study after the intervention and one month after the last intervention. Method of measurement: executive function is measured dimond's shape span, Missing scan test, shape school, day and night stroop,TRAIL-P.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Behavioral dimensions of theory of mind. Timepoint: Behavioral dimensions of theory of mind at the beginning of the study before the intervention and will be measured three months after the start of the study after the intervention and one month after the last intervention. Method of measurement: Behavioral dimensions of theory of mind is measured Theory of Mind Inventory.</sec_outcome>
      <sec_outcome>Behavioral dimensions of executive function. Timepoint: Behavioral dimensions of executive function at the beginning of the study before the intervention and will be measured three months after the start of the study after the intervention and one month after the last intervention. Method of measurement: Behavioral dimensions of executive function is measured Behavioral Rating Executive Function Questionnaire Preschool(BRIEF-P).</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>cognitive sciences and technologies council</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-02-13</approval_date>
        <contact_name>Ethics committee of kharazmi university</contact_name>
        <contact_address>KhU, No. 43. South Mofatteh Ave., Tehran, Iran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
