<?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>IRCT20141216020344N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-03-19</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>Effect of drawing and storytelling on autism</public_title>
      <acronym>autism</acronym>
      <scientific_title>The effect of drawing and storytelling attachment and sleeping habits in children with autism</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-03-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>42</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/53320</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Other.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Autism.</hc_freetext>
      <i_freetext>Intervention 1: After receiving a referral letter from Iran University of Medical Sciences, researchers refer to rehabilitation centers under the supervision of the university and start sampling.  At the beginning the, the objectives of the study are explained to the parents whose children participating in the study. In addition, written consent is obtained from all individuals to participate in the study.  The pre-test is then completed through the Child Sleep Habits and Attachment Questionnaire. The intervention group is asked about this process: every night, if the child and family wish to do so, after dinner and before sleep rituals such as brushing the child, Start painting with the subject alone under the supervision of a mother or father.  Then paint and then take  the sheet from the office and stick it on the wall of the child's room next to the bed, so that the child can see them.  This intervention is performed at least  for 5 nights a week for a month.  Each week, the family takes  paintings of the wall and sends it to the researcher so that the researcher can be sure of the  intervention process. Intervention 2: First, after receiving a letter of introduction from Iran University of Medical Sciences, they refer to the rehabilitation centers under the supervision of the university and start sampling. At the beginning of the study, the objectives of the study are explained to the parents of the children participating in the study. In addition, written consent is obtained from all individuals to participate in the study. The pre-test is then completed through the Child Sleep Habits and Attachment Questionnaire. The intervention group is asked about this process: every night, if the child and family wish to do so, after dinner and before sleep rituals such as brushing the child. If the child and the family want to do this, the story will be read to the child before going to bed and chosen by the parents. After one month, the questionnaire is completed by the parents. Intervention 3: In the control group: interventions are not performed.</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 is encrypted in order to make individuals' identifiable and confidential

When:
From the end of sampling to 6 months after the publication of the article

To whom:
University Ethics Committee, Project Arbitration Committee, Article Arbitration Committee and other researchers

Conditions:
Perform systematic review or meta-analysis by mentioning the document

Where to obtain:
Dr Hamidreza Khoshnezhad Ebrahimi

How to obtain:
After submitting the application via academic email, we will provide the information files to the individuals within a maximum of one week.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Hamidreza Khoshnezhad Ebrahimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran, Modares Highway, after Mirdamad Bridge, Shahid Dastgerdi St. (Zafar), Hazrat Ali Asghar Children's Hospital</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1919816766</zip>
        <telephone>+98 21 2222 2041</telephone>
        <email>khoshnezhad.hr@iums.acir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Hamidreza Khoshnezhad Ebrahimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran, Modares Highway, after Mirdamad Bridge, Shahid Dastgerdi St. (Zafar), Hazrat Ali Asghar Children's Hospital</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1919816766</zip>
        <telephone>+98 21 2222 2045</telephone>
        <email>khoshnezhad.hr@iums.acir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Kid's age should be between 4 to 12 years
Definitive diagnosis of autism in a child
Family willingness to cooperate</inclusion_criteria>
      <agemin>4 years</agemin>
      <agemax>12 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>The child suffers from levels two and three of autism</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>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>After receiving a referral letter from Iran University of Medical Sciences, researchers refer to rehabilitation centers under the supervision of the university and start sampling.  At the beginning the, the objectives of the study are explained to the parents whose children participating in the study. In addition, written consent is obtained from all individuals to participate in the study.  The pre-test is then completed through the Child Sleep Habits and Attachment Questionnaire. The intervention group is asked about this process: every night, if the child and family wish to do so, after dinner and before sleep rituals such as brushing the child, Start painting with the subject alone under the supervision of a mother or father.  Then paint and then take  the sheet from the office and stick it on the wall of the child's room next to the bed, so that the child can see them.  This intervention is performed at least  for 5 nights a week for a month.  Each week, the family takes  paintings of the wall and sends it to the researcher so that the researcher can be sure of the  intervention process.</i_keyword>
      <i_keyword>First, after receiving a letter of introduction from Iran University of Medical Sciences, they refer to the rehabilitation centers under the supervision of the university and start sampling. At the beginning of the study, the objectives of the study are explained to the parents of the children participating in the study. In addition, written consent is obtained from all individuals to participate in the study. The pre-test is then completed through the Child Sleep Habits and Attachment Questionnaire. The intervention group is asked about this process: every night, if the child and family wish to do so, after dinner and before sleep rituals such as brushing the child. If the child and the family want to do this, the story will be read to the child before going to bed and chosen by the parents. After one month, the questionnaire is completed by the parents</i_keyword>
      <i_keyword>In the control group: interventions are not performed</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Attachment. Timepoint: Before and one month after the start of the intervention. Method of measurement: Kinship Center Attachment Questionnaire.</prim_outcome>
      <prim_outcome>Sleep. Timepoint: Before and one month after the start of the intervention. Method of measurement: Children's Sleep Habits Questionnaire 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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-11-30</approval_date>
        <contact_name>Ethics Committee of Iran University of Medical Sciences</contact_name>
        <contact_address>Tehran, Modares Highway, after Mirdamad Bridge, Shahid Dastgerdi St. (Zafar), Hazrat Ali Asghar Children's Hospital Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
