<?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>IRCT201106136794N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2011-08-03</date_registration>
      <primary_sponsor>Vice chancellor of research, faculty of humanities, Tarbiat Modares University</primary_sponsor>
      <public_title>Comparison&#13;
of the computerized cognitive rehabilitation and drug therapy in the&#13;
treatment of attention-deficit/ hyperactivity disorder.</public_title>
      <acronym></acronym>
      <scientific_title>Comparison&#13;
of the effects of computer-assisted cognitive rehabilitation treatment&#13;
and taking Methylphenidate (Ritalin) on executive functions and severity of clinical symptoms in children with attention deficit/&#13;
hyperactivity disorder.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2010-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>34</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/7204</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>3</phase>
      <hc_freetext>Disturbance of activity and attention.</hc_freetext>
      <i_freetext>Intervention 1: For first experimental group (computer assisted cognitive rehabilitation): the intervention included 20 hours (20 one-hour-sessions) of executive functions training using a computer. Trained executive functions included: verbal working memory; visuo-spatial working memory; sustained attention; response inhibition; planning and organization; and information processing speed. Total period of intervention was 2 months. Intervention 2: For second experimental group (drug therapy group): The intervention included 2 or 3 doses of Immediate-release Methylphenidate (Ritalin) per day (each doses included one Ritalin pill). This intervention lasted 2 months.</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>Morteza Nazifi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Departement of psychology, faculty of humanities, Tarbiat Modares university, Jalale Al e Ahmad Highway, Nasr bridge, Tehran.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>111-14115</zip>
        <telephone>+98 21 82880</telephone>
        <email>Pres@modares.ac.ir</email>
        <affiliation>Tarbiat Modares university</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Morteza Nazifi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of psychology, faculty of humanities, Tarbiat Modares university, Jalal e Al e Ahmad highway, Nasr bridge, Tehran.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>111-14115</zip>
        <telephone>+98 21 82880</telephone>
        <email>Pres@modares.ac.ir</email>
        <affiliation>Tarbiat Modares University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion&#13;
criteria: receiving ADHD diagnosis using psychiatric interviews and&#13;
behavioral rating scales; having an age between 7 and 11 years;&#13;
IQ&gt;85.&#13;
Exclusion criteria: Having sever co-morbid mental disorders such as&#13;
oppositional defiant disorder, autism or asperger syndrom, and&#13;
depression; a history of epileptic seizures during past 2 years;&#13;
IQ&lt;85; having some type of motor or perceptual disability which&#13;
interferes with computer operation; having some kind of Medical&#13;
condition which make one to seek immediate treatment.</inclusion_criteria>
      <agemin>7 years</agemin>
      <agemax>11 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F90.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Disturbance of activity and attention</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>For first experimental group (computer assisted cognitive rehabilitation): the intervention included 20 hours (20 one-hour-sessions) of executive functions training using a computer. Trained executive functions included: verbal working memory; visuo-spatial working memory; sustained attention; response inhibition; planning and organization; and information processing speed. Total period of intervention was 2 months.</i_keyword>
      <i_keyword>For second experimental group (drug therapy group): The intervention included 2 or 3 doses of Immediate-release Methylphenidate (Ritalin) per day (each doses included one Ritalin pill). This intervention lasted 2 months.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Intesity of ADHD, combined subtype. Timepoint: preintervention, postintervention, and one month after intervention has finished. Method of measurement: Persian version of SNAP-IV scale.</prim_outcome>
      <prim_outcome>Intesity of ADHD, hyperactive/ impulsive subtype. Timepoint: preintervention, postintervention, and one month after intervention has finished. Method of measurement: Persian version of SNAP-IV scale.</prim_outcome>
      <prim_outcome>Verbal working memory. Timepoint: preintervention, postintervention, and one month after Intervention has finished. Method of measurement: Digit span test from the WISC-R IQ test (Wechsler, 1981).</prim_outcome>
      <prim_outcome>Visuo-spatial working memory. Timepoint: preintervention, postintervention, and one month after Intervention has finished. Method of measurement: Span board task from Wechsler RNI batterey (Kaplan, Fein, Morris, and Delis, 1991).</prim_outcome>
      <prim_outcome>Sustained attention. Timepoint: preintervention, postintervention, and one month after Intervention has finished. Method of measurement: Persian version of continuous performance test (CPT).</prim_outcome>
      <prim_outcome>Intesity of ADHD, inattentive subtype. Timepoint: preintervention, postintervention, and one month after Intervention has finished. Method of measurement: Persian version of SNAP-IV scale.</prim_outcome>
      <prim_outcome>Raven's IQ test. Timepoint: preintervention, postintervention, and one month after Intervention has finished. Method of measurement: Raven's colored progressive matrices (Raven, 1995).</prim_outcome>
      <prim_outcome>Respons inhibition. Timepoint: preintervention, postintervention, and one month after Intervention has finished. Method of measurement: Persian version of continuous performance test (CPT).</prim_outcome>
      <prim_outcome>Planning. Timepoint: preintervention, postintervention, and one month after Intervention has finished. Method of measurement: Persian version of tower of London test.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name>Research Institute for education, Ministry of Education</sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Vice chancellor of research, faculty of humanities, Tarbiat Modares University</source_name>
      <source_name>Research Institute for education, Ministry of Education</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2010-03-13</approval_date>
        <contact_name>The ethics committee of university of Tarbiat Modares, faculty of humanities, vice chancellor of res</contact_name>
        <contact_address>Faculty of humananities, Tarbiat Modares university, Jalale Ale Ahmad Highway, Nasr Bridge, Tehran, Iran. Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
