<?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>IRCT20190701044063N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-02-11</date_registration>
      <primary_sponsor>University of social welfare and rehabilitation sciences</primary_sponsor>
      <public_title>Childhood trauma treatment</public_title>
      <acronym></acronym>
      <scientific_title>The efficacy of Trauma-focused cognitive behavioral therapy on reducing trauma symptoms and improving cognitive function in children with posttraumatic stress symptoms</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-06-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/40581</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Treatment, Randomization description: Eligible individuals are divided into control and intervention  groups by rolling the dice.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Post-traumatic stress disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Individuals in this group receive 16 sessions of 90 minutes, three sessions per week, for trauma-based cognitive-behavioral therapy. In this study, a 16-session protocol of this treatment was used. Session 1: Psychological education. Session 2: Parenting. Session 3: Relaxation. Session 4: Affect Identification &amp; Regulation. Sessions 5 and 6: Cognitive Coping. Sessions 7 and 8: Trauma Processing and Narration Part I. Sessions 9, 10, and 11: Trauma Processing and Narration Part II. Sessions 12, 13, and 14: in vivo mastery. Session 15: Conjoint Parent-Child Sessions. Session 16: Enhancing Safety &amp; Future Development. Intervention 2: Control group: During the study, members of this group are on the waiting list and after completion, they receive the same treatment 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>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 there is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Negar Bagher</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Alborz, Mohammadshahr, Homayoun Villa, Alavi St., Daneshvar Alley, Naghsh Jahan Building 3, Unit 25</address>
        <city>Karaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>318461211</zip>
        <telephone>+98 26 3631 4479</telephone>
        <email>negar7178@yahoo.com</email>
        <affiliation>University of social welfare and rehabilitation sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Negar Bagher</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Alborz, Mohammadshahr, Homayoun Villa, Alavi St., Daneshvar Alley, Naghsh Jahan Building 3, Unit 25</address>
        <city>Karaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>318461211</zip>
        <telephone>+98 26 3136 4479</telephone>
        <email>negar7178@yahoo.com</email>
        <affiliation>University of social welfare and rehabilitation sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Trauma history (grief,sexual abuse,natural disasters,accidents)
Having symptoms associated with trauma and post traumatic stress
Being in the range of 7 to 13 years
Not attending psychotherapy courses for at least one year ago</inclusion_criteria>
      <agemin>7 years</agemin>
      <agemax>13 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Simultaneous diagnosis of autism spectrum disorder, intellectual disorder, childhood psychosis, major depressive disorder in childhood, severe childhood mania, conduct disorder, severe bipolar disorder
Acute psychiatric disorder of parents participating in treatment
Use any psychotropic drugs
Need psychiatric emergencies</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F43.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Post-traumatic stress disorder</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: Individuals in this group receive 16 sessions of 90 minutes, three sessions per week, for trauma-based cognitive-behavioral therapy. In this study, a 16-session protocol of this treatment was used. Session 1: Psychological education. Session 2: Parenting. Session 3: Relaxation. Session 4: Affect Identification &amp; Regulation. Sessions 5 and 6: Cognitive Coping. Sessions 7 and 8: Trauma Processing and Narration Part I. Sessions 9, 10, and 11: Trauma Processing and Narration Part II. Sessions 12, 13, and 14: in vivo mastery. Session 15: Conjoint Parent-Child Sessions. Session 16: Enhancing Safety &amp; Future Development</i_keyword>
      <i_keyword>Control group: During the study, members of this group are on the waiting list and after completion, they receive the same treatment as the intervention group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Post-traumatic Stress Symptoms. Timepoint: Before intervention, 3 to 7 days after intervention. Method of measurement: Parent Report of Post-traumatic Stress Symptoms, Child Report of Post-traumatic Symptoms.</prim_outcome>
      <prim_outcome>Cognitive function. Timepoint: Before intervention, 3 to 7 days after intervention. Method of measurement: Emotional stroop.</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>University of social welfare and rehabilitation sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-02-25</approval_date>
        <contact_name>Ethics Committee in Research, University of Social Welfare and Rehabilitation Sciences</contact_name>
        <contact_address>Koodak Yar Deadlock, Daneshjoo Blvd, Evin, Tehran, University of Social Welfare and Rehabilitation Sciences Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
