<?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>IRCT20200825048511N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-10-17</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>Hippotherapy effect in children with autism</public_title>
      <acronym></acronym>
      <scientific_title>The effect of hippotherapy on behavioral problems and executive function in children with autism spectrum disorder</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-10-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>8</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/50535</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Supportive, Other design features: Single group without control group before and after the intervention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Autism Spectrum Disorder.</hc_freetext>
      <i_freetext>Intervention group: In this study, the participants of the study are children aged 9-12 years old with autism who are members of the Urmia Autism Association and have inclusion criteria and also children and their families want their children to participate in this study. Horse therapy sessions will be performed with the treatment team (including handler, companion and therapist or equestrian instructor). The equine therapy program lasts 10 sessions over 10 weeks in which children will not only ride horses but also pet the horse before they will do horseback riding, talking to horses, walking with horses and visiting horse stables. The duration of each session will be 60-45 minutes. The things that will be done the same in each session are: at the beginning of the sessions; Explain the plans of the same session, change clothes, repeat the rules, read poetry at the gate and observe hygiene (including washing hands and face and combing hair) and in the last three sessions, say goodbye to the horse..</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:
The whole data can be shared after making participants unrecognizable

When:
Starting 6 months after publication

To whom:
Study data only will be  available for people working in academic institutions

Conditions:
Research team members have access to information.

Where to obtain:
Send an email to the responsible author at the following address:
faraztayyar97@gmail.com

How to obtain:
Send an email to the responsible author at the following address:
faraztayyar97@gmail.com

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Faraz Tayyar-Iravanlou</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 9; 6th alley; second 12-meter avenue; Kowsar street; 8 Shahrivar street</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5716846693</zip>
        <telephone>+98 44 3383 3829</telephone>
        <email>faraztayyar97@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Faraz Tayyar-Iravanlou</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 9; 6th alley; second 12-meter avenue; Kowsar street; 8 Shahrivar street</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5716846693</zip>
        <telephone>+98 44 3383 3829</telephone>
        <email>faraztayyar97@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Children with a diagnosis of Autism Spectrum Disorder (ASD) in the medical record
Membership of children in the Urmia Autism Association and having a medical record
Age range of 8-12 years old
No medical prohibition for children to attend educational sessions</inclusion_criteria>
      <agemin>8 years</agemin>
      <agemax>12 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Children who have a history of self-harm or alteration or suicide
Children who have a history of violence against animals or fear of animals
Children who have underlying diseases in addition to autism (such as epilepsy, hypertension, psychiatric illness, asthma, and other illnesses)
Children with a history of hippotherapy</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>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In this study, the participants of the study are children aged 9-12 years old with autism who are members of the Urmia Autism Association and have inclusion criteria and also children and their families want their children to participate in this study. Horse therapy sessions will be performed with the treatment team (including handler, companion and therapist or equestrian instructor). The equine therapy program lasts 10 sessions over 10 weeks in which children will not only ride horses but also pet the horse before they will do horseback riding, talking to horses, walking with horses and visiting horse stables. The duration of each session will be 60-45 minutes. The things that will be done the same in each session are: at the beginning of the sessions; Explain the plans of the same session, change clothes, repeat the rules, read poetry at the gate and observe hygiene (including washing hands and face and combing hair) and in the last three sessions, say goodbye to the horse.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Behavioral disorders score. Timepoint: The questionnaire is completed in two stages, the first stage at the beginning of the equine therapy sessions and before the intervention, the second stage at the end of the intervention and in the closing session by the parents. Method of measurement: In this study, in addition to a questionnaire related to demographic information of children with autism, questionnair of behavioral disorders in children with autism spectrum (parent form) will be used to collect data.</prim_outcome>
      <prim_outcome>Executive functional behavior rating. Timepoint: The questionnair are completed in two stages, the first stage at the beginning of the equine therapy sessions and before the intervention, the second stage at the end of the intervention and in the closing session by the parents. Method of measurement: In this study, in addition to a questionnaire related to demographic information of children with autism, questionnair of  behavioral rating questionnaire of executive function will be used to collect data.</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>Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-08-23</approval_date>
        <contact_name>Ethics committee of school of Pharmacy and Nursing &amp; Midwifery ; Shahid Beheshti University of Medic</contact_name>
        <contact_address>No. 9, 6th Alley,third Davazdah Metri, Kowsar street, 8 Shahrivar street Urmia West Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
