<?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>IRCT20181201041814N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-01-27</date_registration>
      <primary_sponsor>Zahedan University of Medical Sciences</primary_sponsor>
      <public_title>Evaluating The effect of psychodrama group psychotherapy on the symptoms associated with attention deficit / hyperactivity disorder.</public_title>
      <acronym></acronym>
      <scientific_title>the study of The effect of psychodrama on aggression, social anxiety and symptoms attention deficit and hyperactivity, in children with attention deficit and hyperactivity disorder</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-01-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>48</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/35686</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: 24 people of those who receive Ritalin and 24 people of those who receive Atomoxetine will be categorized into 2 groups (control, experiment) randomly. the names of all subjects will be written separately on piece of papers.Then they are thrown into a box and members of both control and experiment groups are selected randomly . The control and experiment groups each included 12 members. This is done separately for those taking Ritalin and Atomoxetine.</study_design>
      <phase>N/A</phase>
      <hc_freetext>attention deficit\ hyperactivity disorder.</hc_freetext>
      <i_freetext>Intervention 1: First Intervention group:10 sessions of the psychodrama group therapy  includes the use of Introduction, magical Store , mirrors for introducing themselves, family imaginations, role play, empty chair, use of body language, storytelling, The task of finding symbolic gifts techniques and methods( such as: assertiveness training, giving responsibility to the members of the group, giving the memoir assignment and challenging thoughts and beliefs of the members of the group that accompany examination of the feelings and experiences of the members during the therapeutic sessions). These sessions will be performed for the Ritalin consumer group within ten weeks, each session takes approximately  90 minutes. Intervention 2: Second Intervention group: 10 sessions of the psychodrama group therapy  includes the use of Introduction, magical Store , mirrors for introducing themselves, family imaginations, role play, empty chair, use of body language, storytelling, The task of finding symbolic gifts techniques and methods( such as: assertiveness training, giving responsibility to the members of the group, giving the memoir assignment and challenging thoughts and beliefs of the members of the group that accompany examination of the feelings and experiences of the members during the therapeutic sessions). These sessions will be performed for the Atomoxetine consumer group within ten weeks, each session takes approximately  90 minutes. Intervention 3: Third Intervention group: Those who take Ritalin do not receive any type of intervention. Intervention 4: control group: Those who take Atomoxetine (Strattera) do not receive any type of intervention.</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 outcome and conclusion of the data will be published in article after the end of the interventions. All questionnaires and scales that are used, are available.

When:
The beginning of availability period will be Summer of 1398

To whom:
Will be available for everyone

Conditions:
no analysis on data is allowed. Only the protocol can be used and referenced.

Where to obtain:
Yunes Zaheri\  zzaheriyones@gmail.com

How to obtain:
After requesting an email, it will be sent within a maximum of two weeks

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Yunes zaheri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Room 213, Block 3, Kaykha dormitory, University Medical sciences, Dr Hasabi Square, University Street</address>
        <city>Zahedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5848115988</zip>
        <telephone>+98 54 3329 5796</telephone>
        <email>zaheriyones@zaums.ac.ir</email>
        <affiliation>Zahedan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Yunes Zaheri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Room 213, Block 3, Kaykha dormitory, University Medical sciences, Dr Hasabi Square, University Street</address>
        <city>Zahedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5848115988</zip>
        <telephone>+98 54 3329 5796</telephone>
        <email>zaheriyones@zaums.ac.ir</email>
        <affiliation>Zahedan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having the attention deficit\ Hyperactivity Disorder
6 to 12 years old
Lack of mental retardation
Taking Ritalin
Taking Atomoxetine</inclusion_criteria>
      <agemin>6 years</agemin>
      <agemax>12 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>presence of another disorder</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F90</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Attention-deficit hyperactivity disorders</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>First Intervention group:10 sessions of the psychodrama group therapy  includes the use of Introduction, magical Store , mirrors for introducing themselves, family imaginations, role play, empty chair, use of body language, storytelling, The task of finding symbolic gifts techniques and methods( such as: assertiveness training, giving responsibility to the members of the group, giving the memoir assignment and challenging thoughts and beliefs of the members of the group that accompany examination of the feelings and experiences of the members during the therapeutic sessions). These sessions will be performed for the Ritalin consumer group within ten weeks, each session takes approximately  90 minutes.</i_keyword>
      <i_keyword>Second Intervention group: 10 sessions of the psychodrama group therapy  includes the use of Introduction, magical Store , mirrors for introducing themselves, family imaginations, role play, empty chair, use of body language, storytelling, The task of finding symbolic gifts techniques and methods( such as: assertiveness training, giving responsibility to the members of the group, giving the memoir assignment and challenging thoughts and beliefs of the members of the group that accompany examination of the feelings and experiences of the members during the therapeutic sessions). These sessions will be performed for the Atomoxetine consumer group within ten weeks, each session takes approximately  90 minutes.</i_keyword>
      <i_keyword>Third Intervention group: Those who take Ritalin do not receive any type of intervention.</i_keyword>
      <i_keyword>control group: Those who take Atomoxetine (Strattera) do not receive any type of intervention</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Aggression grade. Timepoint: Aggressive symptoms are measured before the first session of treatment, and after the end of treatment course. variables will be measured for the last time, a month after the last session of the treatment course. Method of measurement: Child Behaviors checklist of  Achenbach.</prim_outcome>
      <prim_outcome>Social Anxiety grade. Timepoint: Social anxiety symptoms are measured before the first session of treatment, and after the end of treatment course. variables will be measured for the last time, a month after the last session of the treatment course. Method of measurement: Spence Children's Anxiety Scale.</prim_outcome>
      <prim_outcome>Attention deficit\hyperactivity grade. Timepoint: Attention deficit\hyperactivity symptoms are measured before the first session of treatment, and after the end of treatment course. variables will be measured for the last time, a month after the last session of the treatment course. Method of measurement: The Conners Parent Rating Scales.</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>Zahedan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-06-17</approval_date>
        <contact_name>Ethics Committee of Zahedan University of Medical Sciences</contact_name>
        <contact_address>Research Deputy ,University Medical sciences,Dr Hasabi's Square,University Street zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
