<?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>IRCT20211213053378N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-07-11</date_registration>
      <primary_sponsor>University of Isfahan</primary_sponsor>
      <public_title>Therapy of Foster Care Children's Lived Experience of Complex Trauma</public_title>
      <acronym></acronym>
      <scientific_title>Integrating Trauma-Focused Cognitive Behavioral Therapy with Foster Care Children's Lived Experience of Complex Trauma, and Comparing its Effectiveness with Trauma-Focused Cognitive Behavioral Therapy on Complex Posttraumatic Stress Disorder, Behavioral Disorder, Alexithymia, and Resilience</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-07-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>15</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/60851</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Factorial, Purpose: Education/Guidance, Randomization description: In this trial, simple individual randomization method will be used. Randomization will be done using a table of random numbers and by someone other than the researchers, and therefore, allocation concealment will be done. For each participant, a number will be selected from the random table. With his eyes closed, this person will put his finger randomly on a part of the table and choose the corresponding number. If the 1st digit of this number is 1, 2 or 3, that participant will be assigned to the combined intervention group. If the 1st digit of this number was 4, 5, or 6, that participant would be assigned to the trauma-focused cognitive-behavioral therapy group. Finally, if the 1st digit of this number was 7, 8 or 9, that participant will be assigned to the control group. It should be noted that if the target number was zero, or if the group corresponding to a number was already filled, another number will be extracted from the table, Blinding description: The participants and officials of quasi-family centers do not know which groups are the intervention group and which group is the control group, but they are aware that they are participating in a clinical trial and participate in this research with full consent.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Posttraumatic Stress Disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: 1- Integrating Trauma-Focused Cognitive Behavioral Therapy with Foster Care Children's Lived Experience of Complex Trauma, which was prepared based on the achievements of the qualitative part of the doctoral dissertation in psychology, and its validity was approved by a group of psychological experts in the field of psychological trauma. This intervention will be held in the form of 12 two-hour sessions per week. Intervention 2: Intervention group: 2- Trauma-Focused Cognitive Behavioral Therapy(TF-CBT; Cohen et al., 2006) and will be held as 12 two-hour sessions per week. Intervention 3: Control group: They do not receive any intervention during the research, but they are on the waiting list and after the research is completed, they receive the appropriate intervention.</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 further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zivar soltani ghahfarokhi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Psychology,  University of Isfahan, Isfahan, Iran</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673441</zip>
        <telephone>+98 31 3630 3789</telephone>
        <email>Zsoltani1516@gmail.com</email>
        <affiliation>University of Isfahan</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohamad bagher kajbaf</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Psychology, University of Isfahan, Isfahan, Iran</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673441</zip>
        <telephone>+98 31 3793 5458</telephone>
        <email>m.b.kaj@edu.ui.ac.ir</email>
        <affiliation>University of Isfahan</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Complex trauma experience
Age 9-11
Living in Foster Care</inclusion_criteria>
      <agemin>9 years</agemin>
      <agemax>11 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Receive any psychological treatment and medication at the same time as conducting research
Not have Clinical score in complex post-traumatic stress, behavioral disorders and alexythimia questionnaires
Dissatisfaction to participate in research</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F43.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Post-traumatic stress disorder (PTSD)</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: 1- Integrating Trauma-Focused Cognitive Behavioral Therapy with Foster Care Children's Lived Experience of Complex Trauma, which was prepared based on the achievements of the qualitative part of the doctoral dissertation in psychology, and its validity was approved by a group of psychological experts in the field of psychological trauma. This intervention will be held in the form of 12 two-hour sessions per week.</i_keyword>
      <i_keyword>Intervention group: 2- Trauma-Focused Cognitive Behavioral Therapy(TF-CBT; Cohen et al., 2006) and will be held as 12 two-hour sessions per week.</i_keyword>
      <i_keyword>Control group: They do not receive any intervention during the research, but they are on the waiting list and after the research is completed, they receive the appropriate intervention.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Complex Posttraumatic Stress Disorder. Timepoint: Before and after the intervention. Method of measurement: International Trauma Questionnaire.</prim_outcome>
      <prim_outcome>Behavioral Disorder. Timepoint: Before and after the intervention. Method of measurement: Child Behavior Checklist (CBCL).</prim_outcome>
      <prim_outcome>Alexithymia. Timepoint: Before and after the intervention. Method of measurement: Alexithymia questionnaire for children.</prim_outcome>
      <prim_outcome>Resilience. Timepoint: Before and after the intervention. Method of measurement: Resiliency scales of children and adolescents (RSCA).</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 Isfahan</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-11-24</approval_date>
        <contact_name>Ethics committee of  University of Isfahan</contact_name>
        <contact_address>Department of Psychology, University of Isfahan, Isfahan, Iran Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
