<?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>IRCT20210723051963N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-11-06</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>Effectiveness of Unified Protocol for Transdiagnostic Treatment in Children with Anxiety Disorders</public_title>
      <acronym>UP-C</acronym>
      <scientific_title>Effectiveness of Unified Protocol for Transdiagnostic Treatment in Children with Anxiety Disorders</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-11-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/58336</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Among the children referred to the clinic of Tehran Psychiatric Institute, children 8 to 12 years old who will be interviewed with K-SADS-PL semi-structured interview with complaints of anxiety symptoms and those children who receive a diagnosis of anxiety disorders and considering the inclusion and exclusion criteria, enter into research after obtaining informed consent. These children based on restricted randomization are divided into experimental and control groups.
Restricted randomization can be used when the researchers wish that all study groups have the same sample size. In this research, the random allocation rule of the restricted randomization method will be used. The random allocation rule is the simplest method of restricted randomization. In this method, a large block is used for the total sample size, so that at the end of the study, the balance in the number of people assigned to each group is observed. To do this, the researchers first determine the total sample size, then randomly assign a set of them to the experimental group and assign the remainder to the control group. For example, in this study, with a sample size of 30 people, 15 people for the intervention group and 15 people for the control group, a lottery bowl is placed and then the names are removed from the container randomly and replaced, Blinding description: statistical analysis is blind to the research process so that data analysis can be done without bias.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Social phobias. Condition 2: Generalized anxiety disorder. Condition 3: Specific (isolated) phobias. Condition 4: Separation anxiety disorder of childhood. Condition 5: Panic disorder. Condition 6: Agoraphobia.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Unified Protocol for Transdiagnostic Treatment in Children (UP-C). Intervention 2: Control group: Cognitive Behavior Therapy.</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 There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Pantea Ahadianfard</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Mansouri Street, Niyayesh Street, Satarkhan Avenue,</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1445613111</zip>
        <telephone>+98 21 6655 1655</telephone>
        <email>pantea.ahadian@gmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Pantea Ahadianfard</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Mansouri Street, Niyayesh Street, Satarkhan Avenue</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1445613111</zip>
        <telephone>+98 21 6655 1655</telephone>
        <email>pantea.ahadian@gmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age between 8 and 12
Receive a diagnosis of anxiety disorder based on a KSADS-PL diagnostic interview
Do not take psychiatric medication to treat anxiety disorders</inclusion_criteria>
      <agemin>8 years</agemin>
      <agemax>12 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Co-occurrence of depressive disorder based on KSADS-PL diagnostic interview.
Existence of developmental neurological disorders such as autism spectrum disorder and mental retardation based on parental report and KSADS-PL diagnostic interview.
History of receiving psychotherapy for anxiety disorders in the last 2 years
Existence of serious suicidal ideation in KSADS-PL5 diagnostic interview.
Diagnosis or history of bipolar disorder or psychosis based on KSADS-PL diagnostic interview.
Diagnosis of externalized disorders (coping disorders, conduct and attention deficit hyperactivity disorder) based on KSADS-PL diagnostic interview.
Get a diagnosis or previous history of reading disorders</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F40.1</hc_code>
      <hc_code>F41.1</hc_code>
      <hc_code>F40.2</hc_code>
      <hc_code>F93.0</hc_code>
      <hc_code>F41.0</hc_code>
      <hc_code>F40.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Social phobias</hc_keyword>
      <hc_keyword>Generalized anxiety disorder</hc_keyword>
      <hc_keyword>Specific (isolated) phobias</hc_keyword>
      <hc_keyword>Separation anxiety disorder of childhood</hc_keyword>
      <hc_keyword>Panic disorder [episodic paroxysmal anxiety] without agoraphobia</hc_keyword>
      <hc_keyword>Agoraphobia</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Unified Protocol for Transdiagnostic Treatment in Children (UP-C)</i_keyword>
      <i_keyword>Control group: Cognitive Behavior Therapy</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Anxiety Symptoms in Children. Timepoint: Beginning of study, end of study, follow-up after three months. Method of measurement: Screen for Child Anxiety Related Disorders &amp; Kiddie Schedule for Affective Disorders and Schizophrenia and.</prim_outcome>
      <prim_outcome>Emotion Regulation. Timepoint: Beginning of study, end of study, follow-up after three months. Method of measurement: Emotion Regulation Questionnaire for Children and Adolescents &amp; Children's Emotional Management Scales.</prim_outcome>
      <prim_outcome>Cognitive reappraisal. Timepoint: Beginning of study, end of study, follow-up after three months. Method of measurement: Emotion Regulation Questionnaire for Children and Adolescents.</prim_outcome>
      <prim_outcome>Expressive suppression. Timepoint: Beginning of study, end of study, follow-up after three months. Method of measurement: Emotion Regulation Questionnaire for Children and Adolescents.</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>2021-03-16</approval_date>
        <contact_name>Ethics Committee of Iran University of Medical Sciences</contact_name>
        <contact_address>No 1, Mansouri Ave, Niayesh St, Sattarkhan Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
