<?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>IRCT20260510069331N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-05-24</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Effect of ACT  therapy on Well-being and Parenting in Mothers of Autistic children</public_title>
      <acronym></acronym>
      <scientific_title>Effectiveness of Acceptance and Commitment-based Therapy (ACT) on Experiential Avoidance, Intolerance of Uncertainty and Meta-parenting among mothers of children with Autism Spectrum Disorder</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-05-26</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/90081</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Participants were randomly allocated to either the experimental or the control group; the intervention was administered exclusively to the experimental group, Randomization description: Participants will be allocated to either the intervention or control group using simple randomization, generated by a computer-based random number generator. The allocation sequence will be pre-determined and concealed within sequentially numbered, opaque, and identical sealed envelopes. After confirming eligibility and obtaining informed consent, the envelopes will be opened in chronological order of enrollment for each participant. This procedure ensures allocation concealment and minimizes selection bias.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Psychological outcomes in parents of children with autism spectrum disorder (ASD).</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Intervention Description: The intervention group will receive Acceptance and Commitment Therapy (ACT). The intervention will consist of 8 to 10 weekly sessions, each lasting 90 minutes, and will be delivered by a trained psychologist. The protocol is based on the standard ACT model and focuses on the six core processes: acceptance, cognitive defusion, present-moment awareness, self-as-context, values, and committed action. Session content is as follows: Session 1: Group introductions, explanation of the therapy goals and structure, setting session rules, establishing therapeutic rapport, and pre-test administration. Sessions 2–3: Introduction to ACT, experiential avoidance, creative hopelessness, and maladaptive coping patterns. Sessions 4–5: Training and practice of cognitive defusion and self-as-context. Sessions 6–7: Acceptance, mindfulness, and present-moment awareness.	Sessions 8–9: Identifying personal values, goal setting, and committed action. Final session: Review and consolidation of learned skills, reinforcement of their application in daily life, and post-test administration. A two-month follow-up will be conducted after the end of the intervention period to assess the sustainability of the treatment effects. All sessions will be delivered in a structured group format, and no pharmacological agents or medical equipment will be used in this intervention. Intervention 2: Control group: The control group will be assigned to a ‘wait-list’ control condition. During the study period, participants in this group will not receive any psychological or educational interventions similar to the experimental group. In accordance with ethical standards, after the completion of the study, if the intervention proves effective, the educational protocol will be offered to the control group participants. Participants in the control group will complete the pre-test, post-test, and two-month follow-up assessments at the same time intervals as the intervention group.</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:
This dataset includes deidentified individual participant data, including demographic variables and outcome measures collected before and after the intervention. All personal identifiers will be removed before sharing. Only anonymized data related to the study outcomes will be made available to researchers upon reasonable request for scientific use.

When:
Data will become available 6 months after publication of the study results and will remain available for at least 5 years. Access will be provided upon reasonable request to the principal investigator for academic and research purposes.

To whom:
Access is available to qualified researchers and students affiliated with academic or scientific institutions. Data will be shared for scientific and research purposes only, subject to the approval of the principal investigator.

Conditions:
Data usage is restricted to:
Scientific and academic research purposes only.
Analysis outlined in the submitted research proposal.
No commercial, insurance, or legal use.
No redistribution to third parties.
Signed Data Sharing Agreement required, ensuring confidentiality and no re-identification attempts.
Appropriate acknowledgement of the original study in any resulting publications.
Approval by the principal investigator and, if needed, institutional ethics committee.

Where to obtain:
Data and related documents can be obtained through the following contact:
Primary contact:
Principal Investigator: Ladan Kasebzadeh
M.A. Student in General Psychology
Email: Ladan.kasebzadeh@iau.ir

How to obtain:
The process for requesting access to the data is as follows:

The applicant must submit a formal written request to the principal investigator, including a brief research proposal outlining the objectives and planned analyses.
The request will be reviewed within 2–4 weeks based on scientific merit and ethical considerations.
If approved, the applicant must sign a Data Sharing Agreement confirming confidentiality and appropriate data use.
If required, proof of institutional ethics approval must be provided.
The deidentified dataset will be shared electronically within 2 weeks after completion of the required documentation.
The total expected time from submission to data access is approximately 4–6 weeks, depending on the completeness of the request.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Leila Bakhshi Sooreshjani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Islamic Azad University, Behbahan Branch, Shahid Bayani Street, Amir Kabir Boulevard, Behbahan, Khuzestan Province, Iran.</address>
        <city>Behbahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6361713198</zip>
        <telephone>+98 61 5287 0105</telephone>
        <email>le.bakhshi@iau.ac.ir</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Leila Bakhshi Sooreshjani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Islamic Azad University, Behbahan Branch, Shahid Bayani Street, Amir Kabir Boulevard, Behbahan, Khuzestan Province, Iran.</address>
        <city>Behbahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6361713198</zip>
        <telephone>+98 61 5287 0105</telephone>
        <email>le.bakhshi@iau.ac.ir</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Being mother of a child with autism
Being in the age range of 25 to 45 years
Not suffering from specific psychiatric disorders or physical diseases that require the use of drugs or special treatment
Not being divorced or head of household</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Participating in other therapy sessions at the same time
ُuffering from physical diseases or psychiatric disorderس in a way that interferes with treatment sessions or requires hospitalization or drug therapy
Reluctance to continue cooperation</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F43.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Adjustment disorders</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Intervention Description: The intervention group will receive Acceptance and Commitment Therapy (ACT). The intervention will consist of 8 to 10 weekly sessions, each lasting 90 minutes, and will be delivered by a trained psychologist. The protocol is based on the standard ACT model and focuses on the six core processes: acceptance, cognitive defusion, present-moment awareness, self-as-context, values, and committed action. Session content is as follows: Session 1: Group introductions, explanation of the therapy goals and structure, setting session rules, establishing therapeutic rapport, and pre-test administration. Sessions 2–3: Introduction to ACT, experiential avoidance, creative hopelessness, and maladaptive coping patterns. Sessions 4–5: Training and practice of cognitive defusion and self-as-context. Sessions 6–7: Acceptance, mindfulness, and present-moment awareness.	Sessions 8–9: Identifying personal values, goal setting, and committed action. Final session: Review and consolidation of learned skills, reinforcement of their application in daily life, and post-test administration. A two-month follow-up will be conducted after the end of the intervention period to assess the sustainability of the treatment effects. All sessions will be delivered in a structured group format, and no pharmacological agents or medical equipment will be used in this intervention.</i_keyword>
      <i_keyword>Control group: The control group will be assigned to a ‘wait-list’ control condition. During the study period, participants in this group will not receive any psychological or educational interventions similar to the experimental group. In accordance with ethical standards, after the completion of the study, if the intervention proves effective, the educational protocol will be offered to the control group participants. Participants in the control group will complete the pre-test, post-test, and two-month follow-up assessments at the same time intervals as the intervention group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Experiential Avoidance. Timepoint: Pretest, posttest, and 2‑month follow‑up. Method of measurement: Acceptance and Action Questionnaire-II (AAQ-II) developed by Bond et al. (2011).</prim_outcome>
      <prim_outcome>Intolerance of Uncertainty. Timepoint: Pretest, Posttest, and 2-month follow-up. Method of measurement: Intolerance of Uncertainty Scale  (IUS) developed by Freeston et al. (1994).</prim_outcome>
      <prim_outcome>Meta-parenting. Timepoint: Pretest, Posttest, and 2-month follow-up. Method of measurement: meta-parenting questionnaire  developed by Hawk &amp; Holden (2006).</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>2026-04-25</approval_date>
        <contact_name>Ethics committee of Islamic Azad University, Behbahan Branch</contact_name>
        <contact_address>Islamic Azad University, Behbahan Branch, Shahid Bayani Street, Amir Kabir Boulevard, Behbahan, Khuzestan Province, Iran behbahan Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
