<?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>IRCT20260501069223N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-05-05</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>The Effectiveness of Play Therapy Training</public_title>
      <acronym></acronym>
      <scientific_title>The Effectiveness of Non-Directive Play Therapy Training on Loneliness, Social Anxiety, and Aggression in Children with Attention Deficit Hyperactivity Disorde</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-06-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Recruiting</recruitment_status>
      <url>https://irct.ir/trial/89797</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: In this study, in order to achieve completely random allocation and eliminate any researcher involvement or bias, the simple randomization method will be used. First, a complete list of children referred to the counseling center who meet the inclusion criteria for the study will be prepared. Then, an initial numerical identification code will be assigned to each of these individuals. These codes will be entered into a Random Number Generator software. The software will generate a unique random number for each individual. After the numbers are generated, the participants will be listed in ascending order based on the value of the random number. Then, sequentially, the first to the fifteenth individuals on the list will be assigned to the experimental group and the sixteenth to the thirtieth individuals will be assigned to the control group. This process will be designed in such a way that the order of entry or the researcher’s familiarity with the participants will have no role in the allocation process, and it will not be possible to predict the group of any individual before the completion of randomization, Blinding description: In this study, clinical caregivers, the outcome assessor, and data analysts are blinded to the study group allocation, and the information will be coded.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Hyperactivity.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Non‑directive play therapy is an approach that allows the child to freely express his or her feelings and problems during play without direct guidance from the therapist. In this method, the therapist mainly plays the role of an observer and supporter and only provides a safe and accepting environment so that the child can express himself or herself in a natural way. The aim of this method is to strengthen the child’s self‑confidence, self‑awareness, and resolution of psychological problems through experience and free expression in the play setting. In this study, non‑directive play therapy sessions will be conducted in 8 sessions, according to the Kaduson and Schaefer (2001) protocol. Intervention 2: Control group: They do not receive any intervention or treatment.</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 Participant data is completely confidential and I do not intend to publish it.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahsa Heidari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 9, Shahid Raeesi Alley, Emam St</address>
        <city>Mahshahr</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6351916575</zip>
        <telephone>+98 930 749 8065</telephone>
        <email>mahsaheidari980000@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahsa Heidari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 9, Shahid Raeesi Alley, Emam St</address>
        <city>Mahshahr</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6351916575</zip>
        <telephone>+98 930 749 8065</telephone>
        <email>mahsaheidari980000@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Be between 7 and 11 years old.
Have a diagnosis of Attention Deficit/Hyperactivity Disorder (ADHD) confirmed by a clinical psychologist or psychiatrist based on DSM-5 criteria.
Be enrolled in elementary school (grades one to five).
Have the cognitive and communicative ability to participate in group or individual play therapy sessions.</inclusion_criteria>
      <agemin>7 years</agemin>
      <agemax>11 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Have a severe physical problem that interferes with the research process.
Have a confirmed diagnosis of another disorder besides ADHD, such as severe anxiety disorders, other unrelated behavioral disorders, or neuropsychological disorders that may affect the results.
Participate in other therapeutic, psychological training, or play therapy programs during the study period.
Have severe physical or psychological problems that impair participation in sessions, such as severe motor disability, speech impairment, or serious cognitive disorders.
Have sensory problems or specific disabilities that interfere with play therapy activities (such as visual or hearing impairments, or severe physical disabilities without possible adaptation).</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F90</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Attention-deficit hyperactivity disorders</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Non‑directive play therapy is an approach that allows the child to freely express his or her feelings and problems during play without direct guidance from the therapist. In this method, the therapist mainly plays the role of an observer and supporter and only provides a safe and accepting environment so that the child can express himself or herself in a natural way. The aim of this method is to strengthen the child’s self‑confidence, self‑awareness, and resolution of psychological problems through experience and free expression in the play setting. In this study, non‑directive play therapy sessions will be conducted in 8 sessions, according to the Kaduson and Schaefer (2001) protocol.</i_keyword>
      <i_keyword>Control group: They do not receive any intervention or treatment.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Loneliness. Timepoint: before performing the intervention and two weeks after completion of the intervention. Method of measurement: Asher and Wheeler’s Loneliness Questionnaire (1985).</prim_outcome>
      <prim_outcome>Social anxiety. Timepoint: before performing the intervention and two weeks after completion of the intervention. Method of measurement: Reynolds and Richmond Social Anxiety Questionnaire (1978).</prim_outcome>
      <prim_outcome>Aggression. Timepoint: before performing the intervention and two weeks after completion of the intervention. Method of measurement: Eysenck and Wilson Aggression Questionnaire (1975).</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</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2026-02-28</approval_date>
        <contact_name>Ethics Committee of Islamic Azad University of Ahvaz</contact_name>
        <contact_address>Islamic Azad University of Ahvaz, Farhang Shahr. Ahvaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
