<?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>IRCT20220911055936N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-10-02</date_registration>
      <primary_sponsor>دانشگاه محقق اردبیلی</primary_sponsor>
      <public_title>Comparison of the effectiveness of Transcranial Direct Current Brain Stimulation (tDCS) and computer-based cognitive rehabilitation on  children with attention deficit/ hyperactivity disorder</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effectiveness of Transcranial Direct Current Brain Stimulation (tDCS) and computer-based cognitive rehabilitation on improving executive functions, cognitive emotion regulation and impulsivity in  children with attention deficit/ hyperactivity disorder</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-09-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/65830</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: After preparing a list of children with attention deficit/ hyperactivity disorder, 60 of these children will be selected as a simple random sampling method (random listing and selection of people in lottery) and again by simple random method (preparation Lottery list and selection of people as lottery) will be planted in two experimental groups and one control group (each containing 20 people(, Blinding description: The participants in the research will not know about the other experimental groups, the method of intervention, the results, and also the names of the participants. The test groups will be present at the performance site at completely different times.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Attention Deficit/ Hyperactivity Disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention Group One: Electrical Stimulation of the Brain (TDCS): In this group, which includes 20 subjects, the brain's electrical stimulation will be performed for 10 20 -minute current with 2 mAh for subjects. Intervention 2: Second Intervention Group: Computer Cognitive Rehabilitation: In this group, which includes 20 subjects, participants will receive Captain Log Rehabilitation Package 10 times for 60 minutes. Intervention 3: Control Group: In this group, which includes 20 subjects, people will not receive any study interventions and will only be taken pre -test and post -test.</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:
There is no data release plan. But this will be done if necessary

When:
There is no data release plan. But this will be done if necessary

To whom:
It will be available for researchers in academic and scientific institutions

Conditions:
The final results will be provided to the applicants

Where to obtain:
To receive documents, they can refer to the author's email address
sara.taghizadeh1370@gmail.com

How to obtain:
After sending the email and request, the answer will be given in about a month

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sara Taghizadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 19, Ibrahim Abad Blvd, Saheli Ave</address>
        <city>Ardabil</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5613974887</zip>
        <telephone>+98 45 3325 7563</telephone>
        <email>sara.taghizadeh1370@gmail.com</email>
        <affiliation>Mohaghegh Ardabili University.</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sara Taghizadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Educational Sciences and psychology, Mohaghegh Ardabili University, Daneshghah Ave</address>
        <city>Ardebil</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5613974887</zip>
        <telephone>+98 45 3325 7563</telephone>
        <email>s.taghizadeh@uma.ac.ir</email>
        <affiliation>Ardabil University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>having attention deficit/hyperactivity disorder
informed consent of parents and children to participate in the research
not having other psychiatric disorders</inclusion_criteria>
      <agemin>7 years</agemin>
      <agemax>13 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Obtaining low intelligence score on Raven's intelligence test</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F90.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Attention-deficit hyperactivity disorder, predominantly inattentive type</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention Group One: Electrical Stimulation of the Brain (TDCS): In this group, which includes 20 subjects, the brain's electrical stimulation will be performed for 10 20 -minute current with 2 mAh for subjects</i_keyword>
      <i_keyword>Second Intervention Group: Computer Cognitive Rehabilitation: In this group, which includes 20 subjects, participants will receive Captain Log Rehabilitation Package 10 times for 60 minutes</i_keyword>
      <i_keyword>Control Group: In this group, which includes 20 subjects, people will not receive any study interventions and will only be taken pre -test and post -test</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Executive Functions. Timepoint: Conducting electrical brain stimulation (tDCS) once a week for 10 sessions, for the first experimental group. Implementation of the computerized cognitive rehabilitation package twice a week for 10 sessions, for the second experimental group. Conducting the pre-test and post-test before and after the end of the intervention sessions (one week before and after the start and end of the intervention). Method of measurement: 1- N-Back working memory test (to measure  working memory) 2- Stroop color word test (to measure inhibition).</prim_outcome>
      <prim_outcome>Cognitive Emotion Regulation. Timepoint: Conducting electrical brain stimulation (tDCS) once a week for 10 sessions, for the first experimental group. Implementation of the computerized cognitive rehabilitation package twice a week for 10 sessions, for the second experimental group. Conducting the pre-test and post-test before and after the end of the intervention sessions (one week before and after the start and end of the intervention). Method of measurement: cognitive emotion regulation questionnaire (to measure cognitive emotion regulation).</prim_outcome>
      <prim_outcome>Impulsivity. Timepoint: Conducting electrical brain stimulation (tDCS) once a week for 10 sessions, for the first experimental group. Implementation of the computerized cognitive rehabilitation package twice a week for 10 sessions, for the second experimental group. Conducting the pre-test and post-test before and after the end of the intervention sessions (one week before and after the start and end of the intervention). Method of measurement: Balloon risk test (to measure impulsivity).</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>دانشگاه محقق اردبیلی</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-09-03</approval_date>
        <contact_name>Ethics Committee of Mohaghegh Ardabili University</contact_name>
        <contact_address>Mohaghegh Ardabili University, Daneshghah Ave Ardabil Ardabil Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
