<?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>IRCT20240827062877N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-10-09</date_registration>
      <primary_sponsor>Kashan University of Medical Sciences</primary_sponsor>
      <public_title>"The effect of mindfulness based cognitive behavioral therapy for children on learning disorders"</public_title>
      <acronym></acronym>
      <scientific_title>"The effect of mindfulness based cognitive behavioral therapy for children (MBCT-C) on cognitive inhibition, emotional self-regulation, and behavioral problems of children with learning disabilities"</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-10-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>36</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/78743</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: This study has two experimental and control groups, children in both groups will continue their common treatment and after completing the treatment process (MBCT-C), the control group will also receive this intervention if they wish, Randomization description: Assigning participants to intervention and control groups is done by simple random (based on the table of random numbers), In this way, each participant will be assigned a number and with the help of "random.org/lists" they will be randomly assigned to two groups based on their number.</study_design>
      <phase>N/A</phase>
      <hc_freetext>learning disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In this research, there is an intervention group with 18 children aged 9 to 12 years, and the children in this group will be treated with MBCT_C in addition to their usual treatment. mindfulness based cognitive behavioral therapy for children in the form of 12 90-minute sessions that are performed once a week. Intervention 2: Control group: In this research, there is a control group with 18 children aged 9 to 12 years, and the children in this group will continue their usual treatment, and they will also be assured that after completing the research process, if Will receive mindfulness based cognitive behavioral therapy for children.</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 further information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fateme Movahedian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kashan University Of Medical Sciences., Pezeshk Blvd., Qutb Rawandi Blvd., Kashan</address>
        <city>Kashan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8715973474</zip>
        <telephone>+98 31 5510 9999</telephone>
        <email>fatemeh.movahedian2233@gmail.com</email>
        <affiliation>Kashan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fateme Movahedian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kashan University of Medical Sciences., Pezashk Blvd., Qutb Rawandi Blvd., Kashan</address>
        <city>Kashan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8715973474</zip>
        <telephone>0098 31 155109999</telephone>
        <email>fatemeh.movahedian2233@gmail.com</email>
        <affiliation>Kashan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having a learning disorder based on the diagnosis of the child's psychiatrist or clinical psychologist
Having informed consent to participate in the research
Age 9 to 12 years
At least one of the 9 diagnostic items in the learning disorder questionnaire received a positive score</inclusion_criteria>
      <agemin>9 years</agemin>
      <agemax>12 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Suffering from acute physical and mental illness such as diabetes, cancer, bereavement and ..
Receiving various types of psychotherapy</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F81.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Developmental disorder of scholastic skills, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In this research, there is an intervention group with 18 children aged 9 to 12 years, and the children in this group will be treated with MBCT_C in addition to their usual treatment. mindfulness based cognitive behavioral therapy for children in the form of 12 90-minute sessions that are performed once a week.</i_keyword>
      <i_keyword>Control group: In this research, there is a control group with 18 children aged 9 to 12 years, and the children in this group will continue their usual treatment, and they will also be assured that after completing the research process, if Will receive mindfulness based cognitive behavioral therapy for children.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Cognitive inhibition score in the Boshra Test. Timepoint: Before and after the intervention. Method of measurement: Boshra Test.</prim_outcome>
      <prim_outcome>Emotion regulation score in child and adolescent emotion regulation questionnaire (ERQ-CA). Timepoint: Before and after the intervention. Method of measurement: child and adolescent emotion regulation questionnaire (ERQ-CA).</prim_outcome>
      <prim_outcome>The score of behavioral problems in Child Behavior Checklist (CBCL), parent version. Timepoint: Before and after the intervention. Method of measurement: Child Behavior Checklist (CBCL), parent version.</prim_outcome>
      <prim_outcome>The child's score in the learning disorder questionnaire‌(teacher form). Timepoint: Before and after the intervention. Method of measurement: learning disorder questionnaire‌(teacher form).</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>Kashan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-06-29</approval_date>
        <contact_name>Ethics Committee Of Kashan University Of Medical Sciences</contact_name>
        <contact_address>Kashan University Of Medical Sciences., Pezashk Blvd., Qutb Rawandi Blvd., Kashan Kashan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
