<?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>IRCT20210804052078N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-04-01</date_registration>
      <primary_sponsor>Kashan University of Medical Sciences</primary_sponsor>
      <public_title>Peer Group Support on resilience and Self-esteem in adolescents</public_title>
      <acronym></acronym>
      <scientific_title>Efficacy of Peer Group Support on resilience and Self-esteem in adolescents of parents with mood Disorder</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-03-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/58069</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The study population will be first extracted from the children of 12 to 18 years old of parents with major depression or bipolar disorder who are undergoing outpatient treatment in Kargarnejad Clinic or Hospital and will be assigned a unique number. Using SPSS software, 50 people will be randomly selected for the intervention group and 50 people for the control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Major Depressive Disorder. Condition 2: Bipolar Disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: 50 children aged 12 to 18 years with patients with major depression and bipolar disorder, in groups of 6 to 10, for 8 consecutive weeks, one session of 45 to 50 minutes per week. The group is trained by the facilitator according The Kids in Control program is guided by the concepts in Supportive Psychotherapy Learning Guide, Depression: Family Education Guide, Bipolar Disorder Education Guide, and pamphlets on the COPMI website. At the beginning of the sessions and at the end of the eighth week, the Conner and Davidson Resilience Questionnaire and Eisenberg Self-Esteem Questionnaire will be completed by the participants. Intervention 2: Control group: Fifty children aged 12 to 18 years with patients with major depression and bipolar disorder are included in the study as a waiting list. In the beginning and eighth week, the Conner and Davidson Resilience Questionnaire and Eisenberg Self-Esteem Questionnaire are completed by the participants.</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:
Demographic characteristics of parents and adolescents, raw scores of Connor &amp; Davidson test and Rosenberg test

When:
Access period starts one year after the results are published

To whom:
Researchers working for academic and scientific institutes

Conditions:
For metanalyses and systematic reviews and head to head studies

Where to obtain:
Research Center of the Vice Chancellor for Research of Kashan University of Medical Sciences

How to obtain:
Sending a request letter to the Vice Chancellor for Research of Kashan University of Medical Sciences approved by the supervisor attending of the project

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Tayebeh Panjehpour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kargarnezhad Hospital ,Qotb Ravandi Blvd.</address>
        <city>Kashan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8715973446</zip>
        <telephone>+98 31 5554 9111</telephone>
        <email>Panjehpour-t@kaums.ac.ir</email>
        <affiliation>Kashan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fatemeh Assarian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kargarnezhad Hospital, Qotb Ravandi Blvd.</address>
        <city>Kashan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8715973446</zip>
        <telephone>+98 31 5554 9111</telephone>
        <email>Fa-assar@yahoo.com</email>
        <affiliation>Kashan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Adolescents aged 12 to 18 years
Parents who have been diagnosed mood disorder based on DSM 5
Awareness that parents have a psychiatric illness
Written consent of parents or primary caregivers to attend group
Willingness to attend the program
No psychiatric illness in adolescents</inclusion_criteria>
      <agemin>12 years</agemin>
      <agemax>18 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Lack of consent
adolescents do not want to participate or continue participation in the group
Age less than 12 and more than 18 years
Adolescents with psychiatric illness
Absence in more than two sessions</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F32</hc_code>
      <hc_code>F31</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Major depressive disorder, single episode</hc_keyword>
      <hc_keyword>Bipolar disorder</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: 50 children aged 12 to 18 years with patients with major depression and bipolar disorder, in groups of 6 to 10, for 8 consecutive weeks, one session of 45 to 50 minutes per week. The group is trained by the facilitator according The Kids in Control program is guided by the concepts in Supportive Psychotherapy Learning Guide, Depression: Family Education Guide, Bipolar Disorder Education Guide, and pamphlets on the COPMI website. At the beginning of the sessions and at the end of the eighth week, the Conner and Davidson Resilience Questionnaire and Eisenberg Self-Esteem Questionnaire will be completed by the participants.</i_keyword>
      <i_keyword>Control group: Fifty children aged 12 to 18 years with patients with major depression and bipolar disorder are included in the study as a waiting list. In the beginning and eighth week, the Conner and Davidson Resilience Questionnaire and Eisenberg Self-Esteem Questionnaire are completed by the participants.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Resilience. Timepoint: Weeks 0, 8. Method of measurement: Connor &amp; Davidson Questionnaire.</prim_outcome>
      <prim_outcome>Self esteem. Timepoint: Weeks 0, 8. Method of measurement: Rosenberg 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>2022-02-12</approval_date>
        <contact_name>Ethics committee of Kashan University of Medical Sciences</contact_name>
        <contact_address>Kashan University of Medical Sciences,Qotb Ravandi Blvd. kashan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
