<?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>IRCT20120609009975N7</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-03-08</date_registration>
      <primary_sponsor>Vice Chancellor for research of Tehran University of Medical Science</primary_sponsor>
      <public_title>Effects of Cognitive -behavioral interventions on Family Violence and its Consequences</public_title>
      <acronym></acronym>
      <scientific_title>Effects of Cognitive -behavioral interventions on ّFamily violence and its Consequences in Transgender people</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-03-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/44155</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: We will study 50 transgender youth, who will gather from the list of trangender people of the Gender dysphoria association and through Internet. An announcement about this study will first be posted on the Transgender support pages in Instagram and Twitter.  The subjects will  then randomly divided into intervention and control group by using random block size of four .There are 6 modes for blocks, including: TTCC, TCTC, TCCT, CCTT, CTTC, and CTTC for random allocation by blocking and assigning subjects to 2 intervention (T) and control (C) groups. By using the computer we create random numbers; For numbers 1, Compound 1 (CTTC), For numbers 2 , compound 2 (CCTT), for numbers 3 , compound 3 (TCCT), for numbers 4 compound 4 (TCTC), for numbers5 Compound 5 (CTTC) and for numbers 6 Compound 6 (TTCC) will be used.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Gender Dysphoria. Condition 2: family Violence.</hc_freetext>
      <i_freetext>Intervention group : They will be subjected to 8 one-hour online sessions cognitive-behavioral intervention. The first two sessions included information on changing parents' Cognitive of gender dysphoria and violence, and next sessions included training to change violent behavior, anger and calm control, speech skills training, empathy skills, conversation skills, resolution skills, emotion control, stress management..</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is We're going to publish the results and not distribute the data</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahdieh Damanpak</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tohid Square, Dr.Mirkhani St, School of Nursing and Midwifery</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733171</zip>
        <telephone>+98 21 6105 4217</telephone>
        <email>mahdieh.d20@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Farnaz Farnam</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tohid Square, Dr. Mirkhani St, School of Nursing and Midwifery</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733171</zip>
        <telephone>+98 21 6105 4217</telephone>
        <email>f_farnam@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Defenitive diagnosis of Gender dysphoria
Living in a home with parents or guardians
Transgender person's Willingness to participate in the study
Parent's or guardian's of Trangender willingness to participate in the study
Age over 12 years
Being a victim of family violence</inclusion_criteria>
      <agemin>12 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>The transgender person's unwillingness to participate in the study
Parent's or guardian's of Transgender unwillingness to participate in the study
Absence in more than 1 training session</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F64.9</hc_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Gender identity disorder, unspecified</hc_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group : They will be subjected to 8 one-hour online sessions cognitive-behavioral intervention. The first two sessions included information on changing parents' Cognitive of gender dysphoria and violence, and next sessions included training to change violent behavior, anger and calm control, speech skills training, empathy skills, conversation skills, resolution skills, emotion control, stress management.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Family violence. Timepoint: Before intervention, 2 months after the end of the intervention. Method of measurement: Self Report of family violence checklist.</prim_outcome>
      <prim_outcome>Depression. Timepoint: Before intervention , 2 months after the end of the intervention. Method of measurement: Depression- Anxiety- Stress Scale (DASS-21).</prim_outcome>
      <prim_outcome>Anxiety. Timepoint: Before intervention , 2 months after the end of the intervention. Method of measurement: Depression- Anxiety- Stress Scale (DASS-21).</prim_outcome>
      <prim_outcome>Stress. Timepoint: Before intervention , 2 months after the end of the intervention. Method of measurement: Depression- Anxiety- Stress Scale (DASS-21).</prim_outcome>
      <prim_outcome>Self-esteem. Timepoint: Before intervention , 2 months after the end of the intervention. Method of measurement: Rosenberg Self-esteem Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Parents's conflict tactics. Timepoint: Before intervention ,immediately after the intervention. Method of measurement: Conflict tactics scale parents (CTSP).</sec_outcome>
      <sec_outcome>High-risk behaviors. Timepoint: Before intervention , 2 months after the end of the intervention. Method of measurement: High-risk behaviors questions of demographic questionnaire.</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>Vice Chancellor for research of Tehran University of Medical Science</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-02-18</approval_date>
        <contact_name>School of Nursing and Midwifery &amp; Rehabilitation - Tehran University of Medical Sciences</contact_name>
        <contact_address>Tohid square, Dr.Mirkhani street, school of Nursing and Midwifery Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
