<?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>IRCT20240922063112N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-10-06</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>The effectiveness of emotion-oriented cognitive behavioral therapy on emotional and behavioral problems</public_title>
      <acronym></acronym>
      <scientific_title>The effectiveness of emotion-oriented cognitive behavioral therapy on emotional and behavioral problems of elementary school girl students with symptoms of emotional problems</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-09-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/79090</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Factorial, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Anxiety; depression; seclusion; physical complaints; social problems; thinking problems; attention problems; breaking the law; Aggressive behaviors.</hc_freetext>
      <i_freetext>Intervention group: Intervention group: This treatment program consists of 16 sessions designed to treat children and adolescents with emotional disorders in children. The training program consists of two parts: the first 8 sessions of the training part and the second 8 sessions of the training part (confrontation). Also, meetings are scheduled between the therapist and the parent (or one or more of the child's significant others) between therapy sessions. In the first part of the treatment, different emotions are introduced to the child, which starts with the awareness of emotional reactions and leads to the recognition of specific anxiety reactions. The second part of the treatment is dedicated to the use and practice of the new skills acquired in situations that have been increasingly anxiety-provoking or situations that arouse other emotions. Treatment of the child's orientation towards the treatment, introducing the emotion of "joy". The second session: a session to help identify the child's feeling of anxiety and start identifying physical responses, introducing the use of the workbook for introducing the emotion "discomfort and sadness". The third session: an overview of the feeling of anxiety and physical clues and identifying the response. The child's physical actions, introducing the emotion of "anger". Fourth session: meeting with parents to provide more information about treatment for parents and to encourage their participation. The fifth session: introducing relaxation training, introducing the emotion of "pride and pride". The sixth session: introducing the role of anxious self-talk, introducing the feeling of "guilt". Problem for managing anxiety, introduction of "jealousy". Eighth session: Introduction of self-evaluation and self-rewarding for success in managing anxiety, review of skills and their formation in the 4-step plan "Worry". Session 9: Session with Parents in order to provide more information on treatment for parents and encourage their cooperation. The 10th session: practicing the 4-step model of the worried plan in less anxiety-provoking situations (FEAR) including F (n): fear and worry E (g): waiting for unfortunate events or trouble A (r, a) behaviors and thoughts Contributor, R (n): results and consequences. 11th session: continuing to practice the 4-step model in less anxiety-provoking situations, practicing coping with other mildly exciting experiences. 12th session: applying coping skills in the situation Imaginary and real things that cause moderate anxiety. Thirteenth session: Continuation of actual practice of the 4-step model in situations that evoke moderate levels of anxiety and other emotions. Fourteenth session: Application of the 4-step model in imaginary situations that evoke high levels of anxiety. Fifteenth session: Practicing coping skills in real situations that provoke high levels of anxiety and other emotions. The 16th session: Continuation of practicing coping skills in situations with high anxiety, a summary review of the treatment plan, post-test and saying goodbye to 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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Elham sargolzaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>NO2, Iraj afshar Ave, modares Blvd. Zabol</address>
        <city>Zahedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9861645337</zip>
        <telephone>0985432235199</telephone>
        <email>elhamsrg544@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Elham sargolzaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>NO2, Iraj afshae Ave, Modares Blvd</address>
        <city>Zabol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9861645337</zip>
        <telephone>+98 54 3223 5199</telephone>
        <email>elhamsrg544@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Score above 60 on the Toronto Children's Emotional Dysfunction Scale
Having the age of 7 to 12 years
Informed consent to participate in meetings</inclusion_criteria>
      <agemin>7 years</agemin>
      <agemax>12 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Dissatisfaction to continue participating in meetings
Unforeseen events (hospitalization, illness, etc.)
Failure to participate in more than three treatment sessions</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F38</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other mood [affective] disorders</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Intervention group: This treatment program consists of 16 sessions designed to treat children and adolescents with emotional disorders in children. The training program consists of two parts: the first 8 sessions of the training part and the second 8 sessions of the training part (confrontation). Also, meetings are scheduled between the therapist and the parent (or one or more of the child's significant others) between therapy sessions. In the first part of the treatment, different emotions are introduced to the child, which starts with the awareness of emotional reactions and leads to the recognition of specific anxiety reactions. The second part of the treatment is dedicated to the use and practice of the new skills acquired in situations that have been increasingly anxiety-provoking or situations that arouse other emotions. Treatment of the child's orientation towards the treatment, introducing the emotion of "joy". The second session: a session to help identify the child's feeling of anxiety and start identifying physical responses, introducing the use of the workbook for introducing the emotion "discomfort and sadness". The third session: an overview of the feeling of anxiety and physical clues and identifying the response. The child's physical actions, introducing the emotion of "anger". Fourth session: meeting with parents to provide more information about treatment for parents and to encourage their participation. The fifth session: introducing relaxation training, introducing the emotion of "pride and pride". The sixth session: introducing the role of anxious self-talk, introducing the feeling of "guilt". Problem for managing anxiety, introduction of "jealousy". Eighth session: Introduction of self-evaluation and self-rewarding for success in managing anxiety, review of skills and their formation in the 4-step plan "Worry". Session 9: Session with Parents in order to provide more information on treatment for parents and encourage their cooperation. The 10th session: practicing the 4-step model of the worried plan in less anxiety-provoking situations (FEAR) including F (n): fear and worry E (g): waiting for unfortunate events or trouble A (r, a) behaviors and thoughts Contributor, R (n): results and consequences. 11th session: continuing to practice the 4-step model in less anxiety-provoking situations, practicing coping with other mildly exciting experiences. 12th session: applying coping skills in the situation Imaginary and real things that cause moderate anxiety. Thirteenth session: Continuation of actual practice of the 4-step model in situations that evoke moderate levels of anxiety and other emotions. Fourteenth session: Application of the 4-step model in imaginary situations that evoke high levels of anxiety. Fifteenth session: Practicing coping skills in real situations that provoke high levels of anxiety and other emotions. The 16th session: Continuation of practicing coping skills in situations with high anxiety, a summary review of the treatment plan, post-test and saying goodbye to the participants.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Score 8 factor of anxiety-depression, isolation-depression, physical complaints, physical problems, social problems, thinking problems, attention problems, ignoring rules, and aggressive behavior in the Achenbach test (CBCL). Timepoint: 1-2 and 3 months after starting treatment sessions. Method of measurement: Achenbach Child Behavior Inventory (CBCL).</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>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-09-14</approval_date>
        <contact_name>Islamic Azad University - Zahedan Branch (Research Ethics Committee)</contact_name>
        <contact_address>Daneshgah Blvd., Zahedan town Zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
