<?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>IRCT20201007048960N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-12-30</date_registration>
      <primary_sponsor>University of Isfahan</primary_sponsor>
      <public_title>Evaluation of the effect of interventions based on psychological factors, cognitive-behavioral intervention and MC intervention onChild with Disruptive Mood Dysregulation Disorder (DMDD)</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effectiveness of treatment based on psychological factors, child cognitive-behavioral therapy and treatment based on social information processing (MC) on reducing the symptoms of Child with Disruptive Mood Dysregulation Disorder (DMDD) in children 9 to 12 years</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-05-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/52984</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Other design features: In this study, first, in a pilot study, the prevalence of  Disruptive Mood Dysregulation Disorder(DMDD) was investigated and the intervention nodules were identified, Randomization description: After compiling a list of children with Disruptive Mood Dysregulation Disorder(DMDD) through random replacement with a sealed envelope (each prepared and had a numeric code), the researcher placed them in three intervention groups and one control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Disruptive Mood Dysregulation Disorder‪(DMDD).</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Cognitive-behavioral therapy of anger and aggression: Cognitive-behavioral therapy for anger and aggression was developed using cognitive behavioral therapy techniques, cognitive-behavioral therapy for anger and aggression in children (Sukhodolsky and Scahill) and parent management training (also known as behavioral parent training). In this intervention, 9 therapy sessions are developed for children to know emotions, thoughts and behavior and the relationship between them. In subsequent sessions, children learn about cognitive errors and the ways to replace mental errors. In addition, children learn how to solve social problems, regulate emotions and control anger. In the behavioral parent training, parents learn about child behavior management methods in 4 sessions. Intervention 2: Intervention group: Treatment based on psychological factors associated with disordered mood disorder (treatment program developed based on  coaching parents' emotional intelligence and child-related psychological factors).This protocol is developed in 11 sessions based on factors identified during a qualitative interview on children's problems in social situations. In this protocol, children are introduced to the methods of emotion regulation, self-control, empathy, communication skills, courage, responsibility and being open to criticism. They also learn to solve social -cognitive problems based on social information processing model in a concise and short-term manner.  Five intervention sessions based on coaching parents for emotional intelligence are held for parents according to Guttman's proposal. Intervention 3: Intervention group: Social information processing therapy based on Fraser's suggestion(MC): In this protocol developed by Fraser and Et al to reduce anger and aggression in children based on Dodge's social information processing model, first, they are introduced to emotion management and in the subsequent sessions, they learn the correct way of adapting to social situations. They learn how to properly encode information, interpret and document clues and social information, set goals for problem solving, generate appropriate responses, evaluate responses and do a behavior. This protocol is developed in 14 sessions based on Making Choices book. Intervention 4: Control group: Failure to receive intervention during the research.</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 Consult with other research colleagues</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Khatoon Pourmaveddat</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Payame Noor University, Ashouri St.</address>
        <city>Bushehr</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>69768-75168</zip>
        <telephone>+98 77 1354 3202</telephone>
        <email>khmaveddat@yahoo.com</email>
        <affiliation>Bushehr Payame Noor University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Khatoon Pourmaveddat</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Payame Noor University, Ashouri St.</address>
        <city>Bushehr</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>69768-75168</zip>
        <telephone>+98 77 1354 3202</telephone>
        <email>khmaveddat@yahoo.com</email>
        <affiliation>Bushehr Payame Noor University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Child with Disruptive Mood Dysregulation Disorder (DMDD)
Age between 9 to 12 y/o
The consent of the child's parents in the plan</inclusion_criteria>
      <agemin>9 years</agemin>
      <agemax>12 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Reluctance of the parent or child to cooperate</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Cognitive-behavioral therapy of anger and aggression: Cognitive-behavioral therapy for anger and aggression was developed using cognitive behavioral therapy techniques, cognitive-behavioral therapy for anger and aggression in children (Sukhodolsky and Scahill) and parent management training (also known as behavioral parent training). In this intervention, 9 therapy sessions are developed for children to know emotions, thoughts and behavior and the relationship between them. In subsequent sessions, children learn about cognitive errors and the ways to replace mental errors. In addition, children learn how to solve social problems, regulate emotions and control anger. In the behavioral parent training, parents learn about child behavior management methods in 4 sessions.</i_keyword>
      <i_keyword>Intervention group: Treatment based on psychological factors associated with disordered mood disorder (treatment program developed based on  coaching parents' emotional intelligence and child-related psychological factors).This protocol is developed in 11 sessions based on factors identified during a qualitative interview on children's problems in social situations. In this protocol, children are introduced to the methods of emotion regulation, self-control, empathy, communication skills, courage, responsibility and being open to criticism. They also learn to solve social -cognitive problems based on social information processing model in a concise and short-term manner.  Five intervention sessions based on coaching parents for emotional intelligence are held for parents according to Guttman's proposal.</i_keyword>
      <i_keyword>Intervention group: Social information processing therapy based on Fraser's suggestion(MC): In this protocol developed by Fraser and Et al to reduce anger and aggression in children based on Dodge's social information processing model, first, they are introduced to emotion management and in the subsequent sessions, they learn the correct way of adapting to social situations. They learn how to properly encode information, interpret and document clues and social information, set goals for problem solving, generate appropriate responses, evaluate responses and do a behavior. This protocol is developed in 14 sessions based on Making Choices book.</i_keyword>
      <i_keyword>Control group: Failure to receive intervention during the research</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Decreased mean scores in Nelson Anger Questionnaire, Child Behavior Checklist ( subscale aggression ) and irritability questionnaire. Timepoint: Measurement of anger, irritability and aggression at the beginning of the intervention, the end of the intervention and two months after the intervention. Method of measurement: Nelson Anger Questionnaire, Stringaris Irritability and Child Behavior Checklist (Aggression subscale).</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>University of Isfahan</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-11-18</approval_date>
        <contact_name>Ethics Committee of Isfahan University</contact_name>
        <contact_address>Hezar Jerib St., Isfahan University Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
