<?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>IRCT20260812070633N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-09-03</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>The Effectiveness of Internet-Based Mindfulness Training on Parental Stress, Illness Perception, Coping Styles, and Quality of Life Among Parents of Children Newly Diagnosed with Autism Spectrum Disorder</public_title>
      <acronym></acronym>
      <scientific_title>The Effectiveness of Internet-Based Mindfulness Training on Parental Stress, Perceived Illness, Coping Styles, and Quality of Life in Families with Newly Diagnosed Autism</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-08-25</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Recruiting</recruitment_status>
      <url>https://irct.ir/trial/92506</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Upon meeting eligibility criteria and obtaining informed consent, each participant is assigned a code. Participants will be randomly allocated to either the intervention or control group using a random number table via simple randomization. Individuals will be assigned to one of the two groups based on the sequence of random numbers.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Autism.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Parents in the intervention group receive internet-based mindfulness training over the course of eight sessions. The session content includes mindfulness exercises, meditation, breath awareness, awareness of thoughts and emotions, and stress management. Intervention 2: Control group: The control group receives no educational or therapeutic intervention during the study period and is placed on a waiting list. Research assessments are also conducted for this group at the scheduled times.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
The research data include demographic information and results from questionnaires regarding parental stress, illness perception, coping styles, and quality of life. Participants' identifying information will not be disclosed to others.

When:
پس از پایان پژوهش و انتشار نتایج، در صورت درخواست و با رعایت محرمانگی اطلاعات

To whom:
University researchers

Conditions:
The data may be used solely for research purposes, subject to the preservation of confidentiality and the removal of participants' identifying information.

Where to obtain:
The study's principal investigator, via the contact information listed in the IRCT system.

How to obtain:
Upon receipt of a written request, the researcher will review the proposal—considering the research objective and ensuring the confidentiality of participant data—and, if approved, will provide de-identified data.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Samaneh gholinezhad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Unit 1, Saneh 28, Fajr 6, Modiran Industrial Complex</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۳۵۱۴۴۳۶۱۶۱</zip>
        <telephone>023334524578</telephone>
        <email>samanehgholinezhd@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Samaneh gholinezhad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Unit 1, Saneh 28, Fajr 6, Modiran Industrial Complex</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۳۵۱۴۴۳۶۱۶۱</zip>
        <telephone>+98 23 3345 8245</telephone>
        <email>samanehgholinezhd@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having a child with Autism Spectrum Disorder (ASD) confirmed and registered by accredited centers.
A maximum of 12 months (one year) has elapsed since the child's definitive diagnosis.
The family's residence in the city of Semnan
Ability to read and write in Persian to complete the questionnaires.
Willingness and informed consent to participate in all intervention sessions and complete the pre-test and post-test stages.
No prior experience participating in formal, internet-based mindfulness training courses.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Failure to actively participate in more than two sessions of the group intervention.
A parent suffering from acute psychiatric disorders or instability requiring immediate hospitalization.
Occurrence of a family crisis or a severe illness in a parent or child that prevents continued cooperation.
Willingness to withdraw at any stage of the research
Simultaneous initiation of another structured psychotherapy during the conduct of the study.
Need to initiate or make a major change to the parent's psychiatric medication regimen during the intervention period.</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>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Parents in the intervention group receive internet-based mindfulness training over the course of eight sessions. The session content includes mindfulness exercises, meditation, breath awareness, awareness of thoughts and emotions, and stress management.</i_keyword>
      <i_keyword>Control group: The control group receives no educational or therapeutic intervention during the study period and is placed on a waiting list. Research assessments are also conducted for this group at the scheduled times.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Parental stress: The level of stress experienced by the parent in relation to the parenting role and the circumstances arising from the child's autism spectrum disorder, measured using the Parenting Stress Questionnaire. Timepoint: After the intervention ended. Method of measurement: Standard Parenting Stress Index (PSI) questionnaire; standard "Illness Perception Questionnaire – Parent Version" (IPQ-R); Coping with Stressful Situations questionnaire; standard World Health Organization Quality of Life (WHOQOL-BREF) questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>The level of parental stress in parents of children with autism spectrum disorder, measured using a standardized parental stress questionnaire before and after the intervention. Timepoint: Before the intervention (pre-test) and immediately after completion of the 8-session intervention (post-test). Method of measurement: Parental stress will be measured using the Parenting Stress Index (PSI). The questionnaire will be completed by the parents, and the total score will be considered as an indicator of the level of parental stress. The variable will be assessed at two time points: before the intervention (pre-test) and immediately after completion of the intervention (post-test).</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>2026-07-27</approval_date>
        <contact_name>Ethics Committee of Islamic Azad University, Semnan Branch</contact_name>
        <contact_address>Km 5, Damghan Road, Islamic Azad University, Semnan Branch, Semnan, Iran Semnan Semnan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
