<?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>IRCT201109037462N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2011-10-08</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Efficacy of using ball playing in movement skills and coping behaviors in children with autism</public_title>
      <acronym></acronym>
      <scientific_title>Efficacy of using ball playing in movement skills and coping behaviors in children with autism</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2011-11-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>20</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/7924</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Autism Spectrum Disorder.</hc_freetext>
      <i_freetext>Intervention 1: firstly, current treatments, without performing interventional phase are administered during 5 weeks. in this stage current treatments such as Speech Therapy, occupational therapy, Lovaas approach are performed, then Peabody,Vineland and questionnaire for evaluation of treatment of autism as pretests are administered. Intervention 2: using ball playing are performed for 5 weeks. in this interventional stage, children pass 10 therapeutic sessions 2 times per week during 5 weeks. 4 types of ball with different features are used and different ball playing skills such as: catching, throwing, striking by hands and feet or striking by device to ball are administered per session. practices are arranged from easy to hard and firstly, therapist interprets the performing format of practice viva voce and then performs it practically. after that, she helps children to perform  Movement patterns correctly  until they will be able to perform practices independently. practice performing with at least one of the essential balls is the basis of ball playing skills instruction; when children can perform the practice with one ball, other essential balls will be used to increase skills in that practice. at the end of fifth  week, Peabody, Vineland tests and questionnaire for evaluation of treatment of autism as posttests are administered.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohammad Reza Mohammadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Psychiatry and Psychology Research Center, Roozbeh Hospital, South Kargar Avenue, after the Lashkar crossroads, Tehran, IRAN</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 5541 3540</telephone>
        <email>mohammadimr@tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences, Psychiatry research center</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Reza Mohammadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Psychiatry and Psychology Research Center, Roozbeh Hospital, South Kargar Avenue, after the Lashkar crossroads, Tehran, IRAN.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 5541 3540</telephone>
        <email>mohammadimr@tums.ac.ir</email>
        <affiliation>Psychiatry and Psychology Research Center, Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: age 5-7 years old, Autism Spectrum Disorder diagnosis by child and adolescent psychiatrist according to DSM-IV &#13;
Exclusion criteria: epilepsy, cerebral palsy, brain damage, metabolism disorders and other secondary disorders</inclusion_criteria>
      <agemin>5 years</agemin>
      <agemax>7 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F84.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Childhood autism</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>firstly, current treatments, without performing interventional phase are administered during 5 weeks. in this stage current treatments such as Speech Therapy, occupational therapy, Lovaas approach are performed, then Peabody,Vineland and questionnaire for evaluation of treatment of autism as pretests are administered.</i_keyword>
      <i_keyword>using ball playing are performed for 5 weeks. in this interventional stage, children pass 10 therapeutic sessions 2 times per week during 5 weeks. 4 types of ball with different features are used and different ball playing skills such as: catching, throwing, striking by hands and feet or striking by device to ball are administered per session. practices are arranged from easy to hard and firstly, therapist interprets the performing format of practice viva voce and then performs it practically. after that, she helps children to perform  Movement patterns correctly  until they will be able to perform practices independently. practice performing with at least one of the essential balls is the basis of ball playing skills instruction; when children can perform the practice with one ball, other essential balls will be used to increase skills in that practice. at the end of fifth  week, Peabody, Vineland tests and questionnaire for evaluation of treatment of autism as posttests are administered.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Socialization. Timepoint: Baseline, 5 weeks after intervention. Method of measurement: Vaynlnd Adaptive behavior scale.</prim_outcome>
      <prim_outcome>Communication. Timepoint: Baseline, 5 weeks after intervention. Method of measurement: Vaynlnd Adaptive behavior scale.</prim_outcome>
      <prim_outcome>Activities of daily living. Timepoint: Baseline, 5 weeks after intervention. Method of measurement: Vaynlnd Adaptive behavior scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Gross Motor skills. Timepoint: Baseline, 5 weeks after intervention. Method of measurement: Peabody Developmental Motor Scales, Second Edition: PDMS-2.</sec_outcome>
      <sec_outcome>Fine Motor skills. Timepoint: Baseline, 5 weeks after intervention. Method of measurement: Peabody Developmental Motor Scales, Second Edition: PDMS-2.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2011-09-10</approval_date>
        <contact_name>Tehran University of Medical Sciences</contact_name>
        <contact_address>Qods street, Keshavarz Blvd, Tehran Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
