<?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>IRCT20110806007237N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-03-13</date_registration>
      <primary_sponsor>Rasht University of Medical Sciences</primary_sponsor>
      <public_title>Clinical Trial of the Effectiveness of Social Skills Training on Students' Mental Health</public_title>
      <acronym></acronym>
      <scientific_title>Clinical Trial of the Effectiveness of Social Skills Training on Students' Mental Health</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-01-29</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>21</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/29232</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Education/Guidance, Other design features: This pilot will be conducted in a third-grade elementary school in the first semester. Initially, a correspondence will be provided with education for the implementation of the project. After giving enough explanations about the objectives of the project and collected confidential documents from the questionnaires, informed consent will be received from the students' parents. After convenience sampling and giving adequate explanations about the project to the sampled people, self-administered questionnaires will be extracted from parents and then the theory of social skills training will be provided to students by the research team according to the instructions. Training is during 10 sessions, 90 minutes per week, which will be conducted inside the classroom with the presence of the entire students and principal teacher. The purpose of the training sessions is to increase their social skills in school and home environments and reduce their troublesome behaviors. The teacher is allowed to use the instructions during the week based on the training that will be observed (the accompaniment of the teacher is part of the package, not confounding but part of the intervening).</study_design>
      <phase>3</phase>
      <hc_freetext>Mental Health.</hc_freetext>
      <i_freetext>Intervention group: For social skills training to students, the relevant teacher will be used that each week is in relation with them. The content of the social skills training protocol include the Teacher Guidebook and the Child Workbook. This package will be prepared to provide a comprehensive, simple, functional and appropriate with features of Iranian children of 6 to 12 years old. This protocol includes a step-by-step application guide with examples appropriate with age of child for the performer that can be a teacher or training adviser from diploma level to high degrees and includes 10 skills. 1- Self-efficacy 2- Empathy 3. Effective communication 4. Creative thinking 5. Critical thinking 6. Problem-solving 7. Management of emotions 8. Conflict with stress 9. Decision-making. 10. Dare skill and telling No. (Introduction of Social Skills Training Package is presented in the Appendix.).</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 data will be specified and saved by assigning the code

When:
After the study and publication of its paper

To whom:
Researchers and academic people

Conditions:
According to the ethics code of the researchers from the Department of Research and Technology of Guilan University of Medical Sciences, the documentation will be usable.

Where to obtain:
DR Maryam Kousha, Guilan University Of Medical Sciences

How to obtain:
Examining the qualifications of the requesting person and having a code of ethics from a university center will be carried out

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Maryam Kousha</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>15 khordad avenue, Shafa Hospital, Rasht, Iran</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>419395599</zip>
        <telephone>+98 13 3366 6268</telephone>
        <email>maryamkousha@yahoo.com</email>
        <affiliation>Rasht University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Maryam Kousha</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>15 khordad avenue, Shafa Hospital, Rasht, Iran</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>419395599</zip>
        <telephone>+98 13 3366 6268</telephone>
        <email>maryamkousha@yahoo.com</email>
        <affiliation>Rasht University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Students of elementary school in Rasht city aged 9 to 11 years old</inclusion_criteria>
      <agemin>9 years</agemin>
      <agemax>11 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Children whose parents do not consent to participate in the research
Children with a history of participation in other programs of social skills training</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z04.6</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Encounter for general psychiatric examination, requested by authority</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: For social skills training to students, the relevant teacher will be used that each week is in relation with them. The content of the social skills training protocol include the Teacher Guidebook and the Child Workbook. This package will be prepared to provide a comprehensive, simple, functional and appropriate with features of Iranian children of 6 to 12 years old. This protocol includes a step-by-step application guide with examples appropriate with age of child for the performer that can be a teacher or training adviser from diploma level to high degrees and includes 10 skills. 1- Self-efficacy 2- Empathy 3. Effective communication 4. Creative thinking 5. Critical thinking 6. Problem-solving 7. Management of emotions 8. Conflict with stress 9. Decision-making. 10. Dare skill and telling No. (Introduction of Social Skills Training Package is presented in the Appendix.)</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Mental Health. Timepoint: The effectiveness of intervention will be assessed the first study and after the end of the school year based on the score obtained. Method of measurement: from the Strengths and difficulties questionnaire (SDQ) for assessing mental health and Matson's assessment of social skills.</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>Rasht University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-01-29</approval_date>
        <contact_name>Ethics committee of Guilan University of Medical Sciences</contact_name>
        <contact_address>Guilan University of Medical Sciences,Rasht, Namjoo Blvd Rasht Guilan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
