<?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>IRCT20161122031016N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-08-30</date_registration>
      <primary_sponsor>Islamic Azad University, Rasht Branch</primary_sponsor>
      <public_title>Psychological interventions and Pharmacotherapy on improving the condition of children with attention deficit-hyperactivity disorder</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the Effectiveness of Pharmacotherapy and Neurofeedback on Improving Executive Functions and Externalizing Behavior Disorders in children with attention deficit-hyperactivity disorder</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-02-09</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/63814</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The limited block randomization method was used for randomization. In order to determine the 2 experimental and 1 control groups, 15 balls with code A for the experimental group 1, 15 balls with code B for the experimental group 2, and 15 balls with code C for the control group were considered. They will then be placed inside the lottery container and, without replacement, the balls will be randomly removed from the container and the sequence created will be recorded. Next, based on the research sample size, a number of aluminum envelopes are prepared and each random sequence is recorded on a card and the cards are placed in the envelopes in order.</study_design>
      <phase>3</phase>
      <hc_freetext>Attention deficit_ hyperactivity disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Methylphenidate was started twice daily in the morning and evening for 5 weeks at a dose of 5 mg and increased to 10 mg twice daily for one week until the end of the intervention period. Intervention 2: Intervention group: Neurofeedback, 30 sessions for 10 weeks (three times a week, each session 45 minutes). Intervention 3: Control group: Without intervention.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fatemeh Hedayati Shalkouhi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Darvazeh Lakan Street, Gas Square</address>
        <city>رشت</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۴۱۴۷۶۵۴۹۱۹</zip>
        <telephone>+98 13 3347 2099</telephone>
        <email>Fahim_hedayati@yahoo.com</email>
        <affiliation>Islamic Azad University, Rasht Branch</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Bahman Akbari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Darvazeh Lakan Street, Gas Square</address>
        <city>رشت</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۴۱۴۷۶۵۴۹۱۹</zip>
        <telephone>+98 13 3347 2099</telephone>
        <email>bAkbari44@yahoo.com</email>
        <affiliation>Islamic Azad University, Rasht Branch</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Receiving written consent from parents and informed consent of the child
gender (boy)
age range (8 to 12 years)
Average IQ (90 to 109) based on the Wechsler IQ test that is recorded in the child's file and clinical observations recorded by experts
definitive diagnosis of Attention Deficit Hyperactivity Disorder based on the criteria of the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders by a pediatric psychiatrist and child and adolescent clinical psychologist
obtaining the necessary cut score in the Behavior Rating Inventory of Executive Function (BRIEF), Gerard et al. (2000), and Achenbach's Child Behavior Checklist (CBCL), Achenbach (2001) for all three groups (two experimental groups and one control group)</inclusion_criteria>
      <agemin>8 years</agemin>
      <agemax>12 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Suffering from neurological-developmental or other psychological disorders at the same time
receiving other medical and psychological interventions at the same time</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F90.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Attention-deficit hyperactivity disorder, combined type</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Methylphenidate was started twice daily in the morning and evening for 5 weeks at a dose of 5 mg and increased to 10 mg twice daily for one week until the end of the intervention period.</i_keyword>
      <i_keyword>Intervention group: Neurofeedback, 30 sessions for 10 weeks (three times a week, each session 45 minutes)</i_keyword>
      <i_keyword>Control group: Without intervention</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Executive Functions. Timepoint: Before the start of the intervention, after the end of the intervention, Two month after the end of the intervention. Method of measurement: Behavior Rating Inventory of Executive Function (BRIEF).</prim_outcome>
      <prim_outcome>Externalizing Behavior Disorders. Timepoint: Before the start of the intervention, after the end of the intervention, Two month after the end of the intervention. Method of measurement: Achenbach's Child Behavior Checklist (CBCL).</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, Rasht Branch</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-01-26</approval_date>
        <contact_name>Ethics Committee of Islamic Azad University of Rasht</contact_name>
        <contact_address>Darvazeh Lakan Street, Gas Square Rasht Guilan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
