<?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>IRCT20200728048237N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-08-25</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>Cognitive-behavioral based parenting effect on depression in children with cancer</public_title>
      <acronym></acronym>
      <scientific_title>Effectiveness of group cognitive-behavor based parenting in anxiety and depression  symptoms in children with cancer and the role of mechanism of change in treatment</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-08-25</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/50041</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The population will include all children between 7 and 10 years old with cancer referred to Ali Asghar hospital and Children's Medical Center.40 people will be selected by available sampling method and by simple sampling and through lottery, they will be allocated in 2 groups of drug therapy and drug therapy plus parenting treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: depressive disorders. Condition 2: cancer. Condition 3: Anxiety disorders.</hc_freetext>
      <i_freetext>Intervention 1: Control group: drug therapy. This group will receive thetretment as usual, which is medication for anxiety disorders and depression, according to the diagnosis of the center's psychiatrist. The prescription drug for these disorders is usually a class of Selective Serotonin Reuptake Inhibitors (SSRIs). Depending on the severity of the disease and the side effects of the drug, the psychiatrist will use the appropriate drug. This treatment is usually used in the relevant group and the researcher will not change it. The psychiatrist visits the clients once a month. Intervention 2: Intervention group: Pharmacotherapy in addition to parenting education. In this group, in addition to the treatment as usual, which is drug therapy, parenting education will be done for parents. The executive protocol includes 10 two-hour sessions that will be held weekly for parents. The treatment is done in groups and children are not present in this intervention. The present intervention is designed to reduce the symptoms of anxiety and depression in children. This intervention is based on the cognitive-behavioral model and its purpose is to cognitive restructuring the thoughts and beliefs of parents and children.</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 full intervention protocol and informed consent form will be attached to the dissertation. All sessions will be recorded and along with the spss file will be submitted to the department of Clinical Psychology of school of Behavioral Sciences  and Mental Health and the supervisor.

When:
After completing the dissertation and publishing articles

To whom:
Supervisors, consultants and other researchers

Conditions:
The results will be reported in full in the dissertation. And researchers can contact the researcher for meta-analysis to get the information they need.

Where to obtain:
Researchers should refer to Ms. Mehri Moradi and email address moradi.me@tak.iums.ac.ir. The final results will also be mentioned in the dissertation and a copy of the dissertation will be presented in the central library of Iran University of Medical Sciences. The results will also be published in scientific journals.

How to obtain:
The researcher can correspond with Ms. Moradi via email in order to receive the documents, and if there is no violation of confidentiality and ethical principles , she will be answered within a week

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>mehri moradi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 1., School of Behavioral Sciences  and Mental Health (Tehran Institute of Psychiatry)., Mansouri Ave., Sattarkhan Ave</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1445613111</zip>
        <telephone>+98 21 6655 1655</telephone>
        <email>moradi.me@tak.iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mehri Moradi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 1, School of Behavioral Sciences  and Mental Health (Tehran Institute of Psychiatry)., Mansour Ave., Sattarkhan</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1445613111</zip>
        <telephone>0098 66551655</telephone>
        <email>moradi.me@tak.iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The child has a type of cancer
At least 6 months have passed since the diagnosis of cancer and the acute phase of the disease
The child's score on the  internalization subscale of CBCL scale should be higher than the cut-off point
Based on the K-SADs scale, the child is diagnosed with depressive disorder</inclusion_criteria>
      <agemin>7 years</agemin>
      <agemax>10 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>The child or parent has moderate to severe learning disabilities (the parent or child is unable to read and write)
The child has psychotic disorder,
The child's cancer is in the end stage of the disease</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F32</hc_code>
      <hc_code></hc_code>
      <hc_code>F06.4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Major depressive disorder, single episode</hc_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword>Anxiety disorder due to known physiological condition</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: drug therapy. This group will receive thetretment as usual, which is medication for anxiety disorders and depression, according to the diagnosis of the center's psychiatrist. The prescription drug for these disorders is usually a class of Selective Serotonin Reuptake Inhibitors (SSRIs). Depending on the severity of the disease and the side effects of the drug, the psychiatrist will use the appropriate drug. This treatment is usually used in the relevant group and the researcher will not change it. The psychiatrist visits the clients once a month.</i_keyword>
      <i_keyword>Intervention group: Pharmacotherapy in addition to parenting education. In this group, in addition to the treatment as usual, which is drug therapy, parenting education will be done for parents. The executive protocol includes 10 two-hour sessions that will be held weekly for parents. The treatment is done in groups and children are not present in this intervention. The present intervention is designed to reduce the symptoms of anxiety and depression in children. This intervention is based on the cognitive-behavioral model and its purpose is to cognitive restructuring the thoughts and beliefs of parents and children.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Severity of depressive symptoms. Timepoint: Before the intervention, the fifth session, immediately after the intervention, and two months after the intervention. Method of measurement: Child Depression Inventory.</prim_outcome>
      <prim_outcome>Severity of depressive symptoms. Timepoint: Before the intervention, the fifth session, immediately after the intervention, and two months after the intervention. Method of measurement: Spence Children’s Anxiety Scale.</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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-11-05</approval_date>
        <contact_name>Ethics committee of Iran University of Medical Sciences</contact_name>
        <contact_address>Iran University of Medical Sciences., Shahid Hemmat Highway Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
