<?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>IRCT20191113045429N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-06-15</date_registration>
      <primary_sponsor>Vice President For Research and Technology Of Ferdowsi University Of Mashhad</primary_sponsor>
      <public_title>Virtual Reality and  Autism</public_title>
      <acronym>Virtual Reality and  Autism</acronym>
      <scientific_title>Comparing the effect of Risperidone, Virtual Reality on Social Skills, and Behavioral difficulties in Children with Autism</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/48370</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Other design features: Because the tool is built for the first time, the effectiveness of reducing social and behavioral problems is assessed, Randomization description: People with autism were randomly assigned to three groups (virtual reality,ٌRisperidone therapy, and control group). Thirty names were written by chance, and the first 10 people were randomly selected from the Virtual Reality Process, and the second 10 people from the Risperidone group and the third 10 people from the group were waiting for the group to receive no intervention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Autism Disorder.</hc_freetext>
      <i_freetext>Intervention 1: Risperidone drug therapy is the first intervention in a group. The intervention lasted 6 months. The first group to receive drug treatment under the supervision of a psychiatrist received Risperidone medication. First, behavioral and social problems were taken before the test, and after 6 drug treatments, behavioral and social problems were taken twice, and this difference shows the effect of drug therapy on reducing behavioral and social problems. Intervention 2: In the second virtual reality intervention group, behavioral and emotional disorders were taken before the test, and two sessions a week, in which a 45-minute virtual reality training program was taught and lasted for 6 months. In this intervention model, a number of animation images that Communication skills training is done in a three-dimensional way for a child with autism, and at the end of 6 months of post-test intervention, behavioral and emotional disorders were performed. Intervention 3: The control group did not receive any referrals. Only pre-tests completed behavioral and social problems and were placed on a waiting list, and after 6 months they completed the behavioral and social problem questionnaire again.</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:
Comparing the effect of Risperidone, Virtual Reality and Risperidone on Social Skills, and Behavioral difficulties in Children with Autism

When:
1 year later in 2021

To whom:
every one

Conditions:
Article

Where to obtain:
s.soltani@um.ac.ir

How to obtain:
s.soltani@um.ac.ir

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sakineh Soltani Kouhbanani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Azadi Ave. Ferdowsi university of mashhad</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9177948974</zip>
        <telephone>+98 51 3880 3000</telephone>
        <email>s.soltani@um.ac.ir</email>
        <affiliation>Vice President For Research and Technology Of Ferdowsi University Of Mashhad</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sakineh Soltani Kouhbanani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Azadi Ave. Ferdowsi university of mashhad</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9177948974</zip>
        <telephone>+98 51 3880 3000</telephone>
        <email>s.soltani@um.ac.ir</email>
        <affiliation>Vice President For Research and Technology Of Ferdowsi University Of Mashhad</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having autism based on Gilliam test, clinical interview and DSM-5 components
Minimum age 4 years and maximum age 12 years</inclusion_criteria>
      <agemin>4 years</agemin>
      <agemax>16 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>‌parents dont agreed
children  who  have comotbity disorder bisides  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>Treatment - Drugs</i_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Diagnosis</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Risperidone drug therapy is the first intervention in a group. The intervention lasted 6 months. The first group to receive drug treatment under the supervision of a psychiatrist received Risperidone medication. First, behavioral and social problems were taken before the test, and after 6 drug treatments, behavioral and social problems were taken twice, and this difference shows the effect of drug therapy on reducing behavioral and social problems.</i_keyword>
      <i_keyword>In the second virtual reality intervention group, behavioral and emotional disorders were taken before the test, and two sessions a week, in which a 45-minute virtual reality training program was taught and lasted for 6 months. In this intervention model, a number of animation images that Communication skills training is done in a three-dimensional way for a child with autism, and at the end of 6 months of post-test intervention, behavioral and emotional disorders were performed.</i_keyword>
      <i_keyword>The control group did not receive any referrals. Only pre-tests completed behavioral and social problems and were placed on a waiting list, and after 6 months they completed the behavioral and social problem questionnaire again.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Evaluates the behavioral problems of children with autism through a questionnaire. Timepoint: The first group had two virtual reality training sessions per week, the second group received drug therapy every day, but pre-test and post-test measurements were performed only at the beginning and end of the intervention period (6 months). Method of measurement: Behavioral Problems Questionnaire.</prim_outcome>
      <prim_outcome>Evaluates the social  problems of children with autism through a questionnaire. Timepoint: The first group had two virtual reality training sessions per week, the second group received drug therapy every day, but pre-test and post-test measurements were performed only at the beginning and end of the intervention period (6 months). Method of measurement: Social Problem 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>Private</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-11-14</approval_date>
        <contact_name>Ferdowsi University Of Mashhad</contact_name>
        <contact_address>Azadi Ave.Ferdowsi University Of Mashhad Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
