<?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>IRCT20260816070681N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-09-25</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Investigating the Effect of Dialectical Behavior Therapy Training on Alexithymia and Anxiety in Adolescents with Autism</public_title>
      <acronym></acronym>
      <scientific_title>The Effectiveness of an Educational Intervention Based on Dialectical Behavior Therapy on Alexithymia and Anxiety in Adolescents with Autism</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-09-13</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>52</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/93078</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: After identifying and selecting eligible participants, they will be randomly allocated in equal numbers to two groups: an intervention group and a control group (26 participants in each group).
After identifying and selecting eligible participants and obtaining informed consent from their parents, each participant will be assigned a code. The participants will then be allocated equally to the intervention and control groups using simple randomization and a random number table, with 26 participants assigned to the intervention group and 26 participants assigned to the control group. Following random allocation, the intervention group will receive the educational intervention based on Dialectical Behavior Therapy, while the control group will continue to receive the routine school program during the intervention period.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Autism Spectrum Disorder (ASD).</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: A group-based educational intervention based on Dialectical Behavior Therapy (DBT) will be provided in 8 sessions, each lasting 90 minutes, for adolescents with autism. The intervention includes training in distress tolerance, mindfulness, emotion regulation, and interpersonal effectiveness skills. The aim is to improve alexithymia and reduce anxiety. Intervention 2: Control group: The control group will not receive any educational intervention during the intervention period and will continue the usual school program.</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 Individual participant data will not be shared because there is no plan to make individual-level data publicly available. Participant confidentiality and privacy will be maintained, and study results will be reported only in aggregate form.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ruhollah Arshadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Velayat Building (Islamic Azad University of Bushehr Province and Bushehr Branch) – Beginning of Shahid Raisali Delvari Boulevard – Municipality Square</address>
        <city>Bushehr</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7561163877</zip>
        <telephone>+98 77 3424 4860</telephone>
        <email>nazninjoomhoori@mail.ir</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ruhollah Arshadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Velayat Building (Islamic Azad University of Bushehr Province and Bushehr Branch) – Beginning of Shahid Raisali Delvari Boulevard – Municipality Square</address>
        <city>Bushehr</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7561163877</zip>
        <telephone>+98 77 3424 4860</telephone>
        <email>nazninjoomhoori@mail.ir</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having an official diagnosis of Autism Spectrum Disorder (ASD) based on educational and diagnostic records.
Being within the adolescent age range
Being enrolled in exceptional schools in Borazjan.
Having the ability to participate in group intervention sessions.
Providing informed parental consent for participation in the study.
Not receiving other similar interventions concurrently.</inclusion_criteria>
      <agemin>12 years</agemin>
      <agemax>18 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Lack of an official diagnosis of Autism Spectrum Disorder
Being outside the adolescent age range
Inability to participate in group sessions
Lack of parental consent,
Concurrent receipt of similar interventions.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F84.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Autistic disorder</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: A group-based educational intervention based on Dialectical Behavior Therapy (DBT) will be provided in 8 sessions, each lasting 90 minutes, for adolescents with autism. The intervention includes training in distress tolerance, mindfulness, emotion regulation, and interpersonal effectiveness skills. The aim is to improve alexithymia and reduce anxiety.</i_keyword>
      <i_keyword>Control group: The control group will not receive any educational intervention during the intervention period and will continue the usual school program.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Alexithymia refers to difficulty in identifying, describing, and distinguishing one's own and others' emotions. In this study, alexithymia will be assessed using the Toronto Alexithymia Scale (TAS-20), with higher scores indicating greater alexithymia. Anxiety refers to the level of anxiety symptoms in adolescents. In this study, anxiety will be assessed using a standardized anxiety questionnaire appropriate for the adolescent age group. Timepoint: Pre-test: Before the beginning of the educational interventionPost-test: Immediately after completion of the educational intervention. Method of measurement: Alexithymia will be measured using the Toronto Alexithymia Scale (TAS-20), consisting of 20 items rated on a 5-point Likert scale. Higher scores indicate greater alexithymia. Anxiety will be measured using an age-appropriate anxiety questionnaire assessing cognitive, emotional, and physical anxiety symptoms. Higher scores indicate greater anxiety.</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>2026-06-08</approval_date>
        <contact_name>Research Ethics Committee of Islamic Azad University, Marvdasht Branch</contact_name>
        <contact_address>Marvdasht–Persepolis Road, Islamic Azad University, Marvdasht Branch Marvdasht Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
