<?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>IRCT20130721014086N18</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-10-09</date_registration>
      <primary_sponsor>Kashan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of Mandela art therapy on psychological problems</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of Mandela art therapy on psychological problems of mothers of children with autism spectrum disorder</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-10-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>64</target_size>
      <recruitment_status>Recruiting</recruitment_status>
      <url>https://irct.ir/trial/93575</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Samples are made in blocks of four and six using Sealed Envelope Ltd software. 2017 available through www.sealedenvelope.com are assigned to two intervention and control groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Anxiety. Condition 2: Sleep quality.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The intervention is based on Jungian mandala art therapy and follows the Mandala Coloring Therapy (MCT) framework. Each session comprises four main components: introduction and relaxation (10 minutes), mandala coloring (30–40 minutes), guided reflection and group discussion (10–15 minutes), and summary with homework assignment (5–10 minutes). Pre-designed A4 mandalas of gradually increasing complexity are colored using colored pencils, markers, or crayons according to participants' personal preferences; they are encouraged to use three to five colors and to continue coloring from the center toward the outer layers. Following the coloring activity, a guided reflection and group discussion session is facilitated by the researcher to enhance self-awareness, emotion regulation, and personal insight. Intervention 2: Control group: In the control group, mothers are provided with an educational pamphlet based on the National Autistic Society’s guidelines on caring for children with this disorder.</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 The data will be shared upon request and if necessary through the corresponding author. In general, however, given the sensitive nature of the psychological data (depression, anxiety, stress, and sleep quality) and the specific population under study (mothers of children with autism spectrum disorder), maintaining the confidentiality and trust of participants is of paramount importance, and sharing data—even in de-identified form—may compromise this trust.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Mohammad Aghajani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Qotb-e Ravandi Boulevard, Pezeshk Boulevard, School of Nursing and Midwifery</address>
        <city>Kashan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8715988141</zip>
        <telephone>+98 31 5558 9135</telephone>
        <email>aghajani-m@kaums.ac.ir</email>
        <affiliation>Kashan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Aghajani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Qotb-e Ravandi Boulevard, Pezeshk Boulevard, School of Nursing and Midwifery</address>
        <city>Kashan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8715988141</zip>
        <telephone>+98 31 5558 9135</telephone>
        <email>aghajani1362@yahoo.com</email>
        <affiliation>Kashan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Iranian nationality
Residency in the city of Kashan
Having a child receiving care and services at an autism rehabilitation center supervised by the State Welfare Organization
Child with ASD aged between 2 and 12 years
Having at least one child with a definitive diagnosis of autism spectrum disorder (ASD) based on medical records and the diagnosis of a child and adolescent psychiatrist
Maternal age between 18 and 60 years</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Lack of literacy skills required to complete the questionnaires
Physical disability affecting the use of painting tools
Concurrent participation in any psychological intervention—such as mindfulness or cognitive-behavioral therapies—during the study period.
Receipt of art therapy interventions within the past three months. Absence of severe and debilitating physical illnesses (such as active cancer, advanced heart or kidney failure, or severe neurological disorders) that would affect participation in the study or psychological outcomes.
Diagnosis of severe psychiatric disorders (such as schizophrenia, bipolar disorder in the acute phase, or substance use disorder) based on medical records and self-reporting.
History of hospitalization in psychiatric wards in the past six months based on self-report</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F41.9</hc_code>
      <hc_code>Z72.82</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Anxiety disorder, unspecified</hc_keyword>
      <hc_keyword>Problems related to sleep</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The intervention is based on Jungian mandala art therapy and follows the Mandala Coloring Therapy (MCT) framework. Each session comprises four main components: introduction and relaxation (10 minutes), mandala coloring (30–40 minutes), guided reflection and group discussion (10–15 minutes), and summary with homework assignment (5–10 minutes). Pre-designed A4 mandalas of gradually increasing complexity are colored using colored pencils, markers, or crayons according to participants' personal preferences; they are encouraged to use three to five colors and to continue coloring from the center toward the outer layers. Following the coloring activity, a guided reflection and group discussion session is facilitated by the researcher to enhance self-awareness, emotion regulation, and personal insight.</i_keyword>
      <i_keyword>Control group: In the control group, mothers are provided with an educational pamphlet based on the National Autistic Society’s guidelines on caring for children with this disorder.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Depression – Anxiety – Stress. Timepoint: Measurement of depression, anxiety, and stress (DASS-21) at baseline (before the intervention), at the end of the intervention (4 weeks after study initiation), and at follow-up (6 weeks after study initiation). Method of measurement: Depression, anxiety, and stress will be measured using the 21-item Depression, Anxiety, and Stress Scale (DASS-21).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Sleep Quality. Timepoint: Measurement of sleep quality at baseline (before the start of the intervention), at the end of the intervention (4 weeks after the start of the study), and during the follow-up period (6 weeks after the start of the study). Method of measurement: Assessment of sleep quality using the 19-item Pittsburgh Sleep Quality Index (PSQI) questionnaire.</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>2026-09-20</approval_date>
        <contact_name>Research Ethics Committees of Faculty of Medicine &amp; Faculty of Dentistry- Kashan University of Medic</contact_name>
        <contact_address>Qotb-e Ravandi Boulevard – Pezeshk Boulevard – School of Nursing and Midwifery kashan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
