<?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>IRCT20210708051815N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-08-07</date_registration>
      <primary_sponsor>Kashan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of ACT treatment on the psychological components of children of people with PTSD.</public_title>
      <acronym></acronym>
      <scientific_title>The effect of acceptance and commitment therapy on the emotional regulation, psychological flexibility, irritability, and emotional numbness in children of people with post-traumatic stress disorder.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-08-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/57416</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Factorial, Purpose: Education/Guidance, Randomization description: First, the intervention group was coded with the letter A and the control group with the letter B, and then using the website www. sealedenvelope.com/simple-randomiser/v1/lists  randomization list was prepared by selecting a sample size of  70 (two groups of 35) and permuted block randomization method (block size=4). Then, through the obtained randomization list, the subjects included in the study will be assigned to one of the two groups A or B. For example, suppose that in the first four blocks, the permutation method is ABBA, so the first and fourth samples will be assigned to group A and the second and third samples to group B and the same will continue until the last sample (70th person).</study_design>
      <phase>N/A</phase>
      <hc_freetext>Secondary injury in children of people with post-traumatic stress disorder..</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: for the experimental group Specific protocol of treatment based on acceptance and commitment that is done in 8 sessions of 60 to 90 minutes per week and in group sessions.This protocol is known as the Walster and Westerop protocols.Description of the intervention protocol:In this study, a treatment protocol based on acceptance and commitment was used for post-traumatic stress disorder Walster and Westerop, which is a brief description of 8 treatment sessions as follows.The first session of treatment:1. Therapeutic contract.2. Establish a therapeutic relationship.3. Introducing people to the subject of research and treatment and answering questionnaires.The second session of treatment:1. Start by practicing mindfulness.2. Review the last session.3. Discover and examine a person's personal methods and evaluate their impact (creating creative frustration).4. Talking about the temporary and ineffectiveness of avoidance methods.5. Identify the cost of efforts to change negative emotions and thoughts. 6. Using metaphors and giving hope to relieve helplessness.7. Receive feedback and assign homework, creative helplessness.Third session of treatment:1. Begin by practicing mindfulness.2. Review the last session.3. Assisting clients in identifying ineffective control strategies and realizing their futility.4. Accepting painful personal events without conflict with them.5. Getting feedback and doing homework is self-control, not a solution.The fourth session of treatment:1. Start by practicing mindfulness.2. Review the last session.3. Introduce desire as an alternative to control.4. Talking about cognitive fusion and understanding the barriers to desire.5. Receive feedback and assign homework, acceptance.Fifth session of treatment:1. Start by practicing mindfulness.2. Review the last session.3. Introduce cognitive fusion and make changes in language rules.4. Receive feedback and assign homework, cognitive inconsistency.Sixth session of treatment:1. Start by practicing mindfulness.2. Review the last session.3. Explain the concepts of role and context, see yourself as context and make contact with yourself.4. Receive feedback and assign homework, yourself as an observer.Seventh session of treatment:1. Start by practicing mindfulness.2. Review the last session.3. Helping clients identify values ​​and valuable lives, identify values ​​and goals.4. Receive feedback and assign homework, fill in the value form. Intervention 2: Control group: Control group: For the control group, the same number of sessions were held, but they did not use the components of ACT treatment, and research was conducted using the 8-session protocol of life skills training for adolescents.</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 Due to legal restrictions in the Martyr Foundation</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Amir Masoud Mirbagheri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Riazi Square - Niloufar Alley 10 - First door</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8915887647</zip>
        <telephone>+98 35 3823 6421</telephone>
        <email>goosheamm@gmail.com</email>
        <affiliation>Kashan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Amir Masoud Mirbagheri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Niloufar alley math square 10 first door</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8915887647</zip>
        <telephone>+98 35 3823 6421</telephone>
        <email>goosheamm@gmail.com</email>
        <affiliation>Kashan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>People aged 15 to 20 years.
Also, the person with post-traumatic stress disorder (their fathers) in the family should still be alive.
Children must have lived with a person with PTSD until the age of 20.
Also, people should not have a history of mental illness or hospitalization due to mental health problems.
In addition, in anticipation of the intervention, these people should have a higher score than the cut-off in the research tools, which indicates the presence of that sign in the person. The cut-off scores for each device are specified in the description of the tool.</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>20 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having a physical or mental illness during the investigation that leads to hospitalization and interruption of the ACT treatment process.
Changes in the structure of life, such as marriage or divorce during research.
Leave treatment sessions.
Lack of adherence to treatment tasks.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></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: for the experimental group Specific protocol of treatment based on acceptance and commitment that is done in 8 sessions of 60 to 90 minutes per week and in group sessions.This protocol is known as the Walster and Westerop protocols.Description of the intervention protocol:In this study, a treatment protocol based on acceptance and commitment was used for post-traumatic stress disorder Walster and Westerop, which is a brief description of 8 treatment sessions as follows.The first session of treatment:1. Therapeutic contract.2. Establish a therapeutic relationship.3. Introducing people to the subject of research and treatment and answering questionnaires.The second session of treatment:1. Start by practicing mindfulness.2. Review the last session.3. Discover and examine a person's personal methods and evaluate their impact (creating creative frustration).4. Talking about the temporary and ineffectiveness of avoidance methods.5. Identify the cost of efforts to change negative emotions and thoughts. 6. Using metaphors and giving hope to relieve helplessness.7. Receive feedback and assign homework, creative helplessness.Third session of treatment:1. Begin by practicing mindfulness.2. Review the last session.3. Assisting clients in identifying ineffective control strategies and realizing their futility.4. Accepting painful personal events without conflict with them.5. Getting feedback and doing homework is self-control, not a solution.The fourth session of treatment:1. Start by practicing mindfulness.2. Review the last session.3. Introduce desire as an alternative to control.4. Talking about cognitive fusion and understanding the barriers to desire.5. Receive feedback and assign homework, acceptance.Fifth session of treatment:1. Start by practicing mindfulness.2. Review the last session.3. Introduce cognitive fusion and make changes in language rules.4. Receive feedback and assign homework, cognitive inconsistency.Sixth session of treatment:1. Start by practicing mindfulness.2. Review the last session.3. Explain the concepts of role and context, see yourself as context and make contact with yourself.4. Receive feedback and assign homework, yourself as an observer.Seventh session of treatment:1. Start by practicing mindfulness.2. Review the last session.3. Helping clients identify values ​​and valuable lives, identify values ​​and goals.4. Receive feedback and assign homework, fill in the value form.</i_keyword>
      <i_keyword>Control group: Control group: For the control group, the same number of sessions were held, but they did not use the components of ACT treatment, and research was conducted using the 8-session protocol of life skills training for adolescents.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Emotional regulation. Timepoint: Once before the intervention and again after the intervention and also for the third time, one month after the intervention. Method of measurement: Using the Gretz and Roemer Emotion Difficulty Scale Questionnaire (DERS).</prim_outcome>
      <prim_outcome>Psychological flexibility. Timepoint: Once before the intervention and again after the intervention and also for the third time, one month after the intervention. Method of measurement: Using Acceptance and Practice Questionnaire - Second Edition (AAQ-II).</prim_outcome>
      <prim_outcome>Irritability. Timepoint: Once before the intervention and again after the intervention and also for the third time, one month after the intervention. Method of measurement: Using the irritability questionnaire of Crick et al.</prim_outcome>
      <prim_outcome>Emotional numbness. Timepoint: Once before the intervention and again after the intervention and also for the third time, one month after the intervention. Method of measurement: Using Post-Impact Disorder Index (PCL) Questionnaire.</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>Kashan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-07-07</approval_date>
        <contact_name>Ethics Committee of Kashan University of Medical Sciences</contact_name>
        <contact_address>Kashan University of Medical Sciences, Kashan, I.R. Iran Kashan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
