<?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>IRCT20181114041659N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-12-10</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>The effect of behavioral activation treatment on the family of children with cancer</public_title>
      <acronym></acronym>
      <scientific_title>The Effectiveness of behavioral activation treatment on the level of depression and quality of life and psychological well-being of the family of children with Cancer</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-11-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>24</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/35252</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomized method: Limited randomization: This method is used if the researcher tends to have all the study groups having an equal volume. The method used between finite randomization methods is block randomization method.
Block randomization method: Blocking is usually used to balance the number of specimens assigned to each of the study groups.
 Random unit: Individual
Random allocation cloaking: Random allocation cloaking is used in the method used to execute the random sequence on the participants in the study, so that before the assignment of the individual, the assigned group is not specified.
Randomization Tool: Non-transparent sealed envelopes with random sequences.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Depression.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The intervention group will be trained on a weekly basis for up to 90 minutes per treatment session for 7 sessions of Behavioral Activation therapy by clinical psychologist trained in behavioral activation therapy. Content of each session is also formed by providing explanations, exercises and group discussions, homework assignments and summing up, and the reception of the group will also be held in the meetings. At the beginning and the end of the research, the intervention group will be evaluated by questionnaires. Intervention 2: Control group: The control group will not receive any psychological intervention. At the beginning and the end of the study, the control group will be evaluated by questionnaires. In order to observe the ethics in the study, a course of behavioral activation therapy should be provided to the group Will be implemented.</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:
The results of the research after the completion of the research are published in a group without mention.

When:
After completing the research and publishing through the publication of the article

To whom:
The results are published collectively without mentioning names and scholars working in academic and academic institutions can access it.

Conditions:
If you use the results obtained in the health system and set up a psychology unit and equip the hospitals that have cancer patients admitted to the psychology department and assist these people through experienced psychologists.

Where to obtain:
Islamic Azad University, Arsanjan Branch, info@iaua.ac.ir, Maedeh Ahmadzadeh, maedeahmadzade4@gmail.com

How to obtain:
After assuring that the claimant will use the results correctly, the results will be presented to him in a group without mention.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maede Ahmadzade</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Vafa alley.,  Valiasr avenue</address>
        <city>Neyriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7491938195</zip>
        <telephone>+98 71 5382 2120</telephone>
        <email>maedeahmadzade4@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Samad Freidooni</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Professor Mohareri neurology and psychiatry Hospital, Shiraz</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7134814336</zip>
        <telephone>+98 71 3230 5410</telephone>
        <email>Phdsamad2017@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having a child with cancer in the family
The age range of children with cancer is less than 12 years old
Having a doctor's medical record for a child with cancer
Conscious Consent to Entering Research
The absence of other medical problems
Lack of child or parent backwardness</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>One of the parents is afflicted with disorders such as addiction and psychosis
Taking psychiatric medications
Serious suicidal thoughts
Having certain medical conditions</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>P91.4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Neonatal cerebral depression</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: The intervention group will be trained on a weekly basis for up to 90 minutes per treatment session for 7 sessions of Behavioral Activation therapy by clinical psychologist trained in behavioral activation therapy. Content of each session is also formed by providing explanations, exercises and group discussions, homework assignments and summing up, and the reception of the group will also be held in the meetings. At the beginning and the end of the research, the intervention group will be evaluated by questionnaires.</i_keyword>
      <i_keyword>Control group: The control group will not receive any psychological intervention. At the beginning and the end of the study, the control group will be evaluated by questionnaires. In order to observe the ethics in the study, a course of behavioral activation therapy should be provided to the group Will be implemented.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Depression, the score that the subject will receive in the depression, anxiety, and stress questionnaire. Timepoint: Before the onset of behavioral activation therapy sessions, and after the end of treatment sessions, a questionnaire for depression, anxiety, stress will be provided to the control and testing group to complete. Method of measurement: Depression, Anxiety, Stress Scale - 21questions.</prim_outcome>
      <prim_outcome>Quality of Life, the score that a subject will receive on a short-term assessment of the quality of life of the World Health Organization. Timepoint: Before the start of treatment for behavioral therapy sessions and after the end of treatment sessions, the WHO World Health Organization's Quality of Life Scale will be provided to the control and testing team to complete. Method of measurement: The World Health Organization's Quality of Life Scale 26 questions.</prim_outcome>
      <prim_outcome>Psychological well-being, the score that a subject will get in the psychological well-being psychology reef. Timepoint: Before the onset of behavioral activation therapy sessions and after the end of treatment sessions, the psychological well-being questionnaire will be provided to the control and test group to complete. Method of measurement: Psychological well-being questionnaire Rif 84 questions.</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 of Arsanjan Branch</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-11-14</approval_date>
        <contact_name>Ethics Committee of Islamic Azad University, Arsanjan Branch</contact_name>
        <contact_address>Fars, Arsanjan, University Blvd, Educational Complex, Islamic Azad University, Arsanjan Branch Arsanjan Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
