<?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>IRCT20250222064814N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-03-30</date_registration>
      <primary_sponsor>Kermanshah University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the effectiveness of Cognitive-Behavioral Therapy on the improvement of the psychological symptoms of parents with Attention Deficit-Hyperactivity Disorder and measuring its effect on the outcome of their children's treatment</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effectiveness of Cognitive-Behavioral Therapy on the improvement of the psychological symptoms of parents with Attention Deficit-Hyperactivity Disorder and measuring its effect on the outcome of their children's treatment</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-12-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>32</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/82047</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Simple randomization method.
Individual randomization unit.
Randomization tool: Random number table
Allocation concealment: through a third person; Other than the researcher, it has been done to a void bias.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Attention-Deficit, Hyperactivity Disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The intervention of this plan will be based on cognitive-behavioral therapy focused on adult ADHD, which will consist of eight 45-minute weekly sessions (in person or online, as appropriate) and will be implemented individually by a trained therapist for the parent with ADHD. Intervention 2: Control group: The control group will also receive cognitive behavioral therapy in the form of weekly group sessions after the completion of the project due to ethical considerations.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is Due to the privacy of the participants and the confidentiality agreements that exist, it is possible that this file will not be published.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Gerami Boroujerdi,Hasti</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 398, Saidieh Residential Complex, Saidieh St, Hamedan Town</address>
        <city>Hamedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6516953996</zip>
        <telephone>+98 81 3823 2588</telephone>
        <email>hasti.gb@yahoo.com</email>
        <affiliation>Kermanshah University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammadian, Yokhabe</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>South Second House,Third Alley, South Golestan St., Hafez Sq.,  Rudaki Cross., Kermanshah Town</address>
        <city>Kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4855467148</zip>
        <telephone>+98 918 802 6031</telephone>
        <email>yokhabe@gmail.com</email>
        <affiliation>Kermanshah University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Receive a diagnosis of adult ADHD based on a diagnostic interview based on DSM-5
Obtained a score higher than 50 on the Adult ADHD Self-Report Scale (ASRS) questionnaire
Having at least one child aged 7 to 12 years with ADHD under conventional treatment
Not received a diagnosis of severe mental disorders including psychotic spectrum disorders, bipolar type 1, substance use disorder, and severe personality disorders based on SCID-5
Provided informed and written consent to participate in the research
Having a minimum education of 8th grade (completion of middle school)
Not taking psychiatric medications from two months before to the end of the study
Not receiving any psychological intervention from three months before to the end of the study</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>The presence of other severe mental disorders such as other neurodevelopmental disorders, mood disorders, etc.
History of severe drug or alcohol abuse.
The presence of significant cognitive disorders, intellectual disability or below-average IQ</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>N/A</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The intervention of this plan will be based on cognitive-behavioral therapy focused on adult ADHD, which will consist of eight 45-minute weekly sessions (in person or online, as appropriate) and will be implemented individually by a trained therapist for the parent with ADHD.</i_keyword>
      <i_keyword>Control group: The control group will also receive cognitive behavioral therapy in the form of weekly group sessions after the completion of the project due to ethical considerations.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Reducing the score of the stress scale based on the Depression, Anxiety and Stress Scale - 21 Items questionnaire. Timepoint: Measurement of stress scale in the Depression, Anxiety and Stress Scale - 21 Items questionnaire at the beginning of the study, immediately after the intervention, and two months after the intervention. Method of measurement: The Depression, Anxiety and Stress Scale - 21 Items questionnaire.</prim_outcome>
      <prim_outcome>Reducing the score of the depression scale based on the Depression, Anxiety and Stress Scale - 21 Items questionnaire. Timepoint: Measurement of depression scale in the Depression, Anxiety and Stress Scale - 21 Items questionnaire at the beginning of the study, immediately after the intervention, and two months after the intervention. Method of measurement: The Depression, Anxiety and Stress Scale - 21 Items questionnaire.</prim_outcome>
      <prim_outcome>Reducing the score of the anxiety scale based on the Depression, Anxiety and Stress Scale - 21 Items questionnaire. Timepoint: Measurement of anxiety scale in the Depression, Anxiety and Stress Scale - 21 Items questionnaire at the beginning of the study, immediately after the intervention, and two months after the intervention. Method of measurement: The Depression, Anxiety and Stress Scale - 21 Items questionnaire.</prim_outcome>
      <prim_outcome>Improvement of symptoms of attention deficit hyperactivity disorder based on the Adult ADHD Self-Report Scale questionnaire. Timepoint: Measuring the score obtained in the Adult ADHD Self-Report Scale questionnaire at the beginning of the study and immediately after the intervention and two months after the intervention. Method of measurement: The Adult ADHD Self-Report Scale questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Improving the quality of parent relationships based on the Quality of Relationship Inventory questionnaire. Timepoint: Measuring the quality of parental relationships using the Quality of Relationship Inventory questionnaire at the beginning of the study, immediately after the intervention, and two months after the intervention. Method of measurement: The Quality of Relationship Inventory questionnaire.</sec_outcome>
      <sec_outcome>Improving symptoms of attention deficit hyperactivity disorder in children based on the Conners ADHD rating scale questionnaire. Timepoint: Measurement of children's attention deficit hyperactivity disorder symptoms based on the Conners ADHD rating scale at the beginning of the study, immediately after the intervention, and two months after the intervention. Method of measurement: The Conners ADHD rating scale questionnaire.</sec_outcome>
      <sec_outcome>Improvement in children's academic performance based on the assessment of their academic average. Timepoint: Improvement in children's academic performance at the beginning of the study and two months after the intervention based on their academic grade point average. Method of measurement: Assessment of academic average.</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>Kermanshah University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-10-27</approval_date>
        <contact_name>Ethics committee of Kermanshah University of Medical Sciences</contact_name>
        <contact_address>Kermanshah Medical Science Central Building, Shahid Beheshti Blvd, Kermanshah. Kermanshah Kermanshah Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
