<?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>IRCT20240127060825N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-06-20</date_registration>
      <primary_sponsor>Shahid Beheshti University</primary_sponsor>
      <public_title>Effect of cognitive rehabilitation of spatial ability in children with attention deficit hyperactivity disorder</public_title>
      <acronym></acronym>
      <scientific_title>Effect of cognitive rehabilitation of spatial ability on improvement of executive and attentional functions in children with attention deficit hyperactivity disorder</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-07-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/75173</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Diagnostic, Randomization description: Participants were randomly allocated into intervention and control groups using simple randomization at the individual level. A computer-generated random number table was used to create the random allocation sequence. The randomization sequence was generated by a researcher who was not involved in the assessment process. Allocation concealment was performed using sealed opaque envelopes to prevent prediction of group assignment before participant allocation, Blinding description: Due to the nature of the cognitive rehabilitation intervention, blinding of participants and therapists delivering the intervention was not feasible. However, outcome assessments and data scoring procedures were conducted by an evaluator who was unaware of the participants’ group allocation in order to minimize assessment bias. In addition, standardized neuropsychological measures and structured assessment procedures were used to reduce the potential influence of observer expectancy effects.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Attention Deficit Hyperactivity Disorder (ADHD).</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The intervention group received 10 sessions of cognitive rehabilitation using the PARSA Spatial Ability Program. Sessions were conducted twice weekly and lasted 60 minutes each. Participants performed computerized spatial ability training exercises during each session. A cognitive rehabilitation therapist was present throughout the sessions to provide guidance and assistance whenever needed. Intervention 2: Control group: Participants in the control group received 10 sessions of the AREF Emotional Perception Cognitive Rehabilitation Program as an active control intervention. Sessions were conducted once weekly and lasted 15 minutes each.</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 Individual participant data will not be shared in order to protect participant confidentiality and comply with ethical considerations. The data involve children and were collected solely for the purposes of this study.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hajar Sabet</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.33, Alley 27, Zendan Crossroad, south Edalat Blvd., Shiraz Town,</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7168868875</zip>
        <telephone>+98 71 3824 5103</telephone>
        <email>hajarsabet@gmail.com</email>
        <affiliation>Shahid Beheshti Uni versity</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hajar Sabet</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.33, Alley 27, Zendan Crossroad, south Edalat Blvd., Shiraz Town,</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7168868875</zip>
        <telephone>+98 71 3824 5103</telephone>
        <email>hajarsabet@gmail.com</email>
        <affiliation>Shahid Beheshti Uni versity</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Diagnosis of Attention Deficit Hyperactivity Disorder (ADHD) by a child psychiatrist based on DSM diagnostic criteria.
Completion of the Conners Rating Scale by the parents of the mentioned children and obtaining a score higher than 40.
The child’s age should be between 9 and 12 years.
The child should be right-handed.</inclusion_criteria>
      <agemin>9 years</agemin>
      <agemax>12 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Lack of willingness, readiness, or cooperation of the child to participate in the study.
Use of medications other than methylphenidate.
Presence of neurological disorders such as seizures, cerebral palsy, visual impairments, or hearing impairments.
Presence of psychological disorders such as depression, anxiety disorders, learning disorders, or autism spectrum disorder.
Intelligence quotient (IQ) below the normal range.</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>Rehabilitation</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The intervention group received 10 sessions of cognitive rehabilitation using the PARSA Spatial Ability Program. Sessions were conducted twice weekly and lasted 60 minutes each. Participants performed computerized spatial ability training exercises during each session. A cognitive rehabilitation therapist was present throughout the sessions to provide guidance and assistance whenever needed.</i_keyword>
      <i_keyword>Control group: Participants in the control group received 10 sessions of the AREF Emotional Perception Cognitive Rehabilitation Program as an active control intervention. Sessions were conducted once weekly and lasted 15 minutes each.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Change in working memory assessed by the N-Back Test. Timepoint: Working memory was assessed at baseline (before the intervention) and at 40 and 70 days after the initiation of cognitive rehabilitation sessions. Method of measurement: N-Back Test.</prim_outcome>
      <prim_outcome>Change in response inhibition assessed by the Go/No-Go Test. Timepoint: Cognitive flexibility was assessed at baseline (before the intervention) and at 40 and 70 days after the initiation of cognitive rehabilitation sessions. Method of measurement: Wisconsin Card Sorting Test.</prim_outcome>
      <prim_outcome>Change in response inhibition assessed by the Go/No-Go Test. Timepoint: Response inhibition was assessed at baseline (before the intervention) and at 40 and 70 days after the initiation of cognitive rehabilitation sessions. Method of measurement: Go/No-Go Test.</prim_outcome>
      <prim_outcome>Change in attentional networks assessed by the Attention Network Test (ANT). Timepoint: Atentional Networks were assessed at baseline (before the intervention) and at 40 and 70 days after the initiation of cognitive rehabilitation sessions. Method of measurement: Attention Network Test.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Spatial ability was assessed using the Spatial Ability Test of the PARSA cognitive rehabilitation software. Timepoint: Spatial abilities were assessed at baseline (before the intervention) and at 40 and 70 days after the initiation of cognitive rehabilitation sessions. Method of measurement: Gardner Test of Visual Perceptual Skills.</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>Shahid Beheshti University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-07-06</approval_date>
        <contact_name>Research ethics comittees of shahid beheshti university</contact_name>
        <contact_address>Shahid Beheshti University of Medical Sciences and Health Services Administrative Headquarters, Building No. 2, 6th Floor Arabi Street, Yemen Street Shahid Chamran Expressway Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
