<?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>IRCT20180106038230N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-06-30</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Comparing the efficacy of Neurofeedback  and combined treatments in ADHD</public_title>
      <acronym>ADHD</acronym>
      <scientific_title>Comparing the efficacy of methods of Neurofeedback, Neurofeedback and Barkly's Parent Training, Neurofeedback and Computerized Coginetive Rehabilitation on  children with Attention -Deficit/Hyperactivity Disorder</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-05-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>56</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/28698</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: According to entrance criteria fifty six individuals will be selected from available sample community then  assigned randomly based on equal chance and in sequential drawing to 4  experiment groups including group 1,2,3 and the control group. Each group will be included 14 members. Nobody knows anything about the participants’ list and numbers except the researcher, Blinding description: In this study control group participants will have sham,  however they will be unaware, their parents are aware. Also the statistical analyzer has no  data about the research process.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Attention Deficit Hyperactivity Disorder.</hc_freetext>
      <i_freetext>Intervention 1: First intervention group: Only Neurofeedback training, the intervention  will be performed during 30 training sessions 3 days per week and each  session will be lasted 30 minutes using a set of Procomp 2 and BioGraph INFINITI software made by Canada (having treatment protocol  based on BioGraph INFINITI baseline). Intervention 2: Second intervention group: Neurofeedback and Barkly Parental training. The intervention will be performed during 30 training sessions 3 days per week and each session will be lasted 30 minutes using the set of  Procomp 2 and BioGraph INFINITI software made by Canada (having treatment protocol  based on BioGraph INFINITI baseline), beside 9 session Barckly parental  training for 60 minutes once in a week. Intervention 3: The third intervention group: Neurofeedback  and Computerized Cognitive Rehabilitation training,This group will have 30 sessions training, 3 days per week and each session will be lasted 30 minutes using the set of  Procomp 2 and BioGraph INFINITI software made by Canada (having treatment protocol  based on BioGraph INFINITI baseline), beside, 15 session Computerized Cognitive Rehabilitation training for 30 minutes 3 times a week by Cogiplus software made by SCHUHFRIED company in Austria. Intervention 4: Control group:The intervention will be performed during 30 sham training sessions, 3 days per  week and each session will be lasted 30 minutes  using the set of Procomp 2 and BioGraph INFINITI software made by Canada.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no additional Information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Elahe Hajeforoush</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.4 Aseman Flat, Harandizade Dead end,  Majlesi  Allay, 2Apadana Ave,</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8166763631</zip>
        <telephone>+98 31 3630 3512</telephone>
        <email>E.Hajeforoush@khuisf.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Elahe Hajeforoush</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.4 Aseman Flat, Harandizade Dead end,  Majlesi  Allay, 2Apadana Ave,</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8166763631</zip>
        <telephone>+98 31 3630 3512</telephone>
        <email>E.Hajeforoush@khuisf.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>psychiatrist diagnosis of ADHD
Being an Elementary school student
Having IQ more than 85score according to Wechsler IQ test
No using drugs affecting the CNS
completing informed consent form
Being male
Age group 6 to 13 years</inclusion_criteria>
      <agemin>6 years</agemin>
      <agemax>13 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Having other psychiatric and cognitive- neurological disorders
having Epileptic seizure in the last two years</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F90</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Attention-deficit hyperactivity disorders</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>First intervention group: Only Neurofeedback training, the intervention  will be performed during 30 training sessions 3 days per week and each  session will be lasted 30 minutes using a set of Procomp 2 and BioGraph INFINITI software made by Canada (having treatment protocol  based on BioGraph INFINITI baseline).</i_keyword>
      <i_keyword>Second intervention group: Neurofeedback and Barkly Parental training. The intervention will be performed during 30 training sessions 3 days per week and each session will be lasted 30 minutes using the set of  Procomp 2 and BioGraph INFINITI software made by Canada (having treatment protocol  based on BioGraph INFINITI baseline), beside 9 session Barckly parental  training for 60 minutes once in a week.</i_keyword>
      <i_keyword>The third intervention group: Neurofeedback  and Computerized Cognitive Rehabilitation training,This group will have 30 sessions training, 3 days per week and each session will be lasted 30 minutes using the set of  Procomp 2 and BioGraph INFINITI software made by Canada (having treatment protocol  based on BioGraph INFINITI baseline), beside, 15 session Computerized Cognitive Rehabilitation training for 30 minutes 3 times a week by Cogiplus software made by SCHUHFRIED company in Austria.</i_keyword>
      <i_keyword>Control group:The intervention will be performed during 30 sham training sessions, 3 days per  week and each session will be lasted 30 minutes  using the set of Procomp 2 and BioGraph INFINITI software made by Canada.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Symptoms of ADHD measured by IVA+ PLUS test. Timepoint: Pretest,two and a half  month post test &amp; two and a half  month follow up. Method of measurement: Integrative Visual and Auditory performance test.</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>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-04-16</approval_date>
        <contact_name>Ethics committee of Islamic Azad university  Isfahan(Khorasgan) branch</contact_name>
        <contact_address>Daneshgah Blvd, Arghavanyeh, East Jey Ave, Azad Islamic Univercity  Isfahan(Khorasgan) branch Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
