<?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>IRCT20210227050518N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-08-14</date_registration>
      <primary_sponsor>Institute for cognitive science studies</primary_sponsor>
      <public_title>Examining the effect of training pretend play based on theory of mind in children with autism spectrum disorder</public_title>
      <acronym></acronym>
      <scientific_title>Examining the effect of training pretend play based on theory of mind in children with autism spectrum disorder</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-08-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/54634</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Random sequencing will be done through a table of random numbers in such a way that from the second page of the third column of the table of random numbers with a sequence of 3 numbers whose last digit is even as an experimental group and numbers whose last digit is odd as a control group Is selected. Concealment of random allocation is sealed through the envelope by preparing a number of envelopes and writing the numbers of the table, experimental group, and control on the sheet and placing them in the envelope, respectively, and in order to maintain a random sequence, on external surfaces. Envelopes are numbered in the same way. Finally, the lids of the envelopes are glued and placed inside a box, respectively. At the beginning of the registration of participants, according to the order of entry of eligible participants into the study, one of the envelopes will be opened in order and the assigned group of the participant will be revealed, Blinding description: Pre-test and post-test will be performed by a trained assessor who is not aware of the patients' group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Autism spectrum disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Children after pre-test will undergo 20 sessions of pretend play training with a identiplay approach based on theory of mind for 45 minutes and 4 times a week and the current treatment approach. Sessions will be held individually. Intervention 2: Control group: They will receive standard rehabilitation therapies such as occupational therapy, cognitive rehabilitation, and speech therapy. Intervention 3: Intervention group: After the pre-test, the children undergo 20 sessions of pretend play training without the theory of mind approach for 45 minutes, 4 times a week, and regular rehabilitation treatments. Meetings are held individually.</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:
In the form of an article

When:
In the form of an article

To whom:
In the form of an article

Conditions:
In the form of an article

Where to obtain:
In the form of an article

How to obtain:
In the form of an article

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Samaneh Karamali Esmaili</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran, 1449614535, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۳۴۸۷ - ۱۵۴۵۹</zip>
        <telephone>+98 21 2222 2059</telephone>
        <email>esmaeili.s@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Samaneh Karamali Esmaili</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran, 1449614535, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۳۴۸۷ - ۱۵۴۵۹</zip>
        <telephone>+98 21 2222 2059</telephone>
        <email>esmaeili.s@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age range 9-5 years
Definitive diagnosis of autism spectrum disorder based on the opinion of a psychiatrist
Gilliam-Garz diagnostic test with a score of 30 or higher to diagnose mild to moderate autism spectrum disorder
Assessing the history of the child's play in the form of interviews with the mother and also observing the child's free play will be examined to assess the level of pretend to play in the child, performing 3 examples of pretend play that the child can show 3 consecutive or more pretending behaviors in the play
the literacy of reading and writing in Persian for parents</inclusion_criteria>
      <agemin>5 years</agemin>
      <agemax>9 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Lack of normal hearing and vision</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>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Children after pre-test will undergo 20 sessions of pretend play training with a identiplay approach based on theory of mind for 45 minutes and 4 times a week and the current treatment approach. Sessions will be held individually.</i_keyword>
      <i_keyword>Control group: They will receive standard rehabilitation therapies such as occupational therapy, cognitive rehabilitation, and speech therapy.</i_keyword>
      <i_keyword>Intervention group: After the pre-test, the children undergo 20 sessions of pretend play training without the theory of mind approach for 45 minutes, 4 times a week, and regular rehabilitation treatments. Meetings are held individually.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Theory of Mind. Timepoint: Beginning and end of the study. Method of measurement: Theory of mind inventory, Sally-Anne and smartiz task, penny-hiding game.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Task-based theory of mind. Timepoint: Beginning and end of the study. Method of measurement: penny-hiding game, Sally-Anne task and Smartiz task.</sec_outcome>
      <sec_outcome>Level of theory of mind from family perspective. Timepoint: Beginning and end of the study. Method of measurement: Theory of mind inventory.</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>Institute for cognitive science studies</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-01-31</approval_date>
        <contact_name>Ethics committee of Institute for Cognitive Sciences</contact_name>
        <contact_address>No. 216, between Aban &amp; Azar, khordad Ave, Golestan Blvd, Ahvaz Town Ahvaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
