<?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>IRCT20221211056773N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-01-16</date_registration>
      <primary_sponsor>Arsanjan Islamic Azad University</primary_sponsor>
      <public_title>The effectiveness of child-centered mindfulness on emotion regulation, cognitive flexibility, and anxiety and depression levels in children with diabetes</public_title>
      <acronym></acronym>
      <scientific_title>The effectiveness of child-centered mindfulness on emotion regulation, cognitive flexibility, and anxiety and depression levels in children with diabetes</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-12-13</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/67341</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Supportive, Randomization description: In this study, 30 people are selected according to similar research, in an accessible way. Then random replacement is done by lottery method (one number will be assigned to each of the sampled people). We write down the numbers on paper, fold them and put them in a container. We mix and stir the papers completely. Then we take out the papers one by one and put one number in the first group and one number in the second group.Then random application will be done. In this way, one group is known as "control group" and the other group is known as "intervention group". The lottery will be done by putting the two groups obtained from the previous step (random replacement step) into two separate envelopes and placing them in a container. Then we randomly take one envelope out of the container and assign it to the "intervention group" and the other envelope to the "control group". Research data are analyzed using SPSS version 21 statistical package software in social sciences.</study_design>
      <phase>N/A</phase>
      <hc_freetext>diabetes.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: This group will undergo child-centered mindfulness therapy for 10 sessions of 45 minutes based on a certain schedule in the sessions determined according to the headings of the educational package taken from Debra Burdick's method of child and adolescent mindfulness. Intervention 2: Control group: This group will not receive any intervention and will only be evaluated based on research variables before the intervention and after the intervention for the intervention group.</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>Dr. Sara Deh Gorgi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hafez Hospital</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7194634786</zip>
        <telephone>+98 71 3647 9531</telephone>
        <email>rcpsych1@sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Afsaneh nouri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ghasedasht</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7133864396</zip>
        <telephone>+98 71 3233 6408</telephone>
        <email>Afsane1@yahoo.com</email>
        <affiliation>Arsanjan Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>All children with type 2 diabetes</inclusion_criteria>
      <agemin>10 years</agemin>
      <agemax>12 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Outside the age group of 10 to 12 years</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>بیماریهای </hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>بیماریهای طبی</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: This group will undergo child-centered mindfulness therapy for 10 sessions of 45 minutes based on a certain schedule in the sessions determined according to the headings of the educational package taken from Debra Burdick's method of child and adolescent mindfulness.</i_keyword>
      <i_keyword>Control group: This group will not receive any intervention and will only be evaluated based on research variables before the intervention and after the intervention for the intervention group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>"Determining the effectiveness of child-centered mindfulness on anxiety" anxiety score in the Spence anxiety questionnaire and obtaining a score higher than 60 in this questionnaire. Timepoint: Evaluation of the anxiety score before the intervention and after 10 sessions of mindfulness training. Method of measurement: The way to measure the outcome variable is through the Spence Anxiety Questionnaire.</prim_outcome>
      <prim_outcome>"Determining the effectiveness of child-centered mindfulness on depression" depression score in Maria's children's depression questionnaire and obtaining a score higher than 27 in this questionnaire. Timepoint: Assessment of depression score before the intervention and after 10 sessions of mindfulness training. Method of measurement: The method of measuring the outcome variable is through the Maria Kovacs Children's Depression Questionnaire.</prim_outcome>
      <prim_outcome>"Determining the effectiveness of child-centered mindfulness on emotion regulation" The emotion regulation score in the cognitive regulation of emotion questionnaire by Garnofsky and obtaining a score higher than 50 in this questionnaire. Timepoint: Evaluation of the emotion regulation score before the intervention and after 10 sessions of mindfulness training. Method of measurement: The way to measure the outcome variable is through the Garnofsky emotion regulation questionnaire.</prim_outcome>
      <prim_outcome>"Determining the effectiveness of child-centered mindfulness on cognitive flexibility" cognitive flexibility score in Dennis and Vanderwaal's cognitive flexibility questionnaire and obtaining a score of less than 20 in this questionnaire. Timepoint: Evaluation of the cognitive flexibility score before the intervention and after 10 sessions of mindfulness training. Method of measurement: The method of measuring the outcome variable is through Dennis and Vanderwaal's cognitive flexibility questionnaire.</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>Arsanjan Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-10-10</approval_date>
        <contact_name>Research ethics committee</contact_name>
        <contact_address>University blvd Arsanjan Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
