<?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>IRCT20251121068065N13</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-07-10</date_registration>
      <primary_sponsor>Islamic Azad University, Yasuj Branch</primary_sponsor>
      <public_title>Comparing the effectiveness of emotion-focused and child-centered mindfulness play therapy on children's adjustment, emotion regulation, and executive functioning</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the effectiveness of emotion regulation-based play therapy with child-centered mindfulness-based intervention on adjustment, emotion management, and executive functions of children with attention deficit hyperactivity disorder (ADHD)</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-08-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Pending</recruitment_status>
      <url>https://irct.ir/trial/91358</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Eligible participants will be selected through purposive sampling and randomly allocated in a 1:1:1 ratio to two intervention groups and one control group using simple randomization. The random allocation sequence will be generated before participant enrollment using the RAND function in Microsoft Excel. Allocation concealment will be ensured using sequentially numbered, sealed, opaque envelopes prepared by an independent researcher not involved in participant recruitment or outcome assessment. After completion of the baseline assessment, each participant will be assigned to the next available envelope, which will determine group allocation.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Children with attention-deficit/hyperactivity disorder (ADHD).</hc_freetext>
      <i_freetext>Intervention 1: Control group: Participants will receive no intervention during the study period and will continue with routine care. Outcome assessments will be performed at the same time points as in the intervention groups. Intervention 2: Intervention group:  Participants will receive emotion-based play therapy in eight face-to-face group sessions, each lasting 90 minutes, delivered by the researcher according to the study protocol. Intervention 3: Intervention group:  Participants will receive child-centered mindfulness training in eight face-to-face group sessions, each lasting 90 minutes, delivered by the researcher according to the study protocol.</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. Armin Mahmoudi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Islamic Azad University, Yasuj Branch, 4th km Si Sakht Road, Yasuj, Kohgiluyeh and Boyer-Ahmad Province.</address>
        <city>Yasuj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7591493686</zip>
        <telephone>+98 74 3331 3213</telephone>
        <email>Armin.Mahmoudi@iau.ac.ir</email>
        <affiliation>Islamic Azad University, Yasuj Branch</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Armin Mahmoudi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Islamic Azad University, Yasuj Branch, 4th km Si Sakht Road, Yasuj, Kohgiluyeh and Boyer-Ahmad Province.</address>
        <city>Yasuj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7591493686</zip>
        <telephone>+98 917 743 0926</telephone>
        <email>Armin.Mahmoudi@iau.ac.ir</email>
        <affiliation>Islamic Azad University, Yasuj Branch</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Children aged 6–12 years.
Diagnosis of attention-deficit/hyperactivity disorder (ADHD) according to DSM-5 criteria.
Written informed consent provided by parents or legal guardians.
Child's assent to participate in the study.
No pharmacological or non-pharmacological interventions targeting executive functions or emotion regulation within the previous 6 months.</inclusion_criteria>
      <agemin>6 years</agemin>
      <agemax>12 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Comorbid autism spectrum disorder, intellectual disability, or other severe psychiatric disorders.
Severe learning disabilities interfering with participation in the intervention.
Current use of psychiatric medications that may affect study outcomes.
Withdrawal of parental consent or child assent during the study.
Absence from more than two intervention sessions.</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>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: Participants will receive no intervention during the study period and will continue with routine care. Outcome assessments will be performed at the same time points as in the intervention groups.</i_keyword>
      <i_keyword>Intervention group:  Participants will receive emotion-based play therapy in eight face-to-face group sessions, each lasting 90 minutes, delivered by the researcher according to the study protocol.</i_keyword>
      <i_keyword>Intervention group:  Participants will receive child-centered mindfulness training in eight face-to-face group sessions, each lasting 90 minutes, delivered by the researcher according to the study protocol.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Adaptability. Timepoint: Adaptability will be assessed at baseline, immediately after the intervention, and at the 2-month follow-up. Method of measurement: Adaptability will be assessed using the Children's Adaptation Questionnaire developed by Dokhanchi (1998), consisting of 37 items rated on a 4-point Likert scale (0–3). Total scores range from 0 to 111, with higher scores indicating greater adaptability. Certain items are reverse-scored according to the questionnaire guidelines.</prim_outcome>
      <prim_outcome>Emotion management. Timepoint: Emotion management will be assessed at baseline, immediately after the intervention, and at the 2-month follow-up. Method of measurement: Emotion management will be assessed using the Child Emotion Management Questionnaire (Zeman et al., 2001). This 38-item instrument is rated on a 3-point Likert scale (rarely, sometimes, often) and includes three subscales: anger, sadness, and worry. The total score is calculated by summing all item scores, with higher scores indicating greater emotion management difficulties.</prim_outcome>
      <prim_outcome>Executive functions. Timepoint: Executive functions will be assessed at baseline, immediately after the intervention, and at the 2-month follow-up. Method of measurement: Executive functions will be assessed using the Executive Function Scale developed by Barclay (2012) for children and adolescents. The scale consists of 70 items rated on a 4-point Likert scale (never to always) and includes five subscales: time management, organization/problem solving, inhibition/self-control, self-motivation, and emotional regulation. The total score is calculated as the sum of all items, with higher scores indicating greater executive dysfunction.</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, Yasuj Branch</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-12-11</approval_date>
        <contact_name>Research Ethics Committee of Islamic Azad University - Yasuj Branch</contact_name>
        <contact_address>Islamic Azad University, Yasuj Branch, 4th km., Si Sakht Road,Yasuj. Yasuj Kohgilouyeh-va-Boyrahmad Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
