<?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>IRCT20200708048063N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-11-02</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>The effect of mental health education on self-disability of female students.</public_title>
      <acronym></acronym>
      <scientific_title>The effect of mental health education on self-handicapping of secondary school girl students in Abadeh, 2019-2020</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-03-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>120</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/49633</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Based on the formula for determining the average sample size with an error of 5% and a power of 90% and an absolute error of 5 units, the sample size of at least 55 people was calculated, which is used according to the drop of 60 people. Of these 4 schools, 2 schools are randomly selected as the intervention group and the other 2 schools as the control group. Also, a total of 60 people are randomly selected and included in the study, Blinding description: In this study, students who were randomly placed in the control and control groups were kept in the blind group. People in the control group were unaware of the intervention on individuals in the control group. They do not have education. They do not know about the education of the control group, which is 27 other students.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Check the degree of self-disability.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: After filling out the questionnaire and determining the scores of the questionnaire, people with average to high scores are randomly placed in the intervention group. People who enter the intervention group enter eight training sessions based on mental health topics for one month. Immediately after teaching these students, a self-disability test is performed to assess the degree of self-disability.The content of the sessions is as follows: Session 1: Mental health education, Session 2: Self-knowledge and review of the previous session, Session 3: Positive communication with others and review of previous sessions, Session 4: Optimism and positive thinking, Session 5: Emotional intelligence And review of previous sessions, session 6: independence and autonomy, session 7: personality development and review of previous sessions, session 8: purposeful training in life and review of previous sessions. Intervention 2: Control group: People who enter the control group after the self-disability test do not receive any mental health-based training, and after the training, the self-disability test is taken from the intervention group.</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:
After the intervention and data analysis, the results of the study will be shared after identifying the participants.

When:
from 1400

To whom:
All researchers

Conditions:
If there is a letter from the ethics committee and permission of the ethics committee.

Where to obtain:
--

How to obtain:
--

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fatemeh Nematollahi2@gmail.com</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Emam Khomini St ، Bahman،Abadeh</address>
        <city>Abadeh</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>73911454611</zip>
        <telephone>+98 71 4438 2925</telephone>
        <email>fatemehnematollahi2@gmail.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fatemeh Nematolali</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Emam Khomini St ، Bahman،Abadeh</address>
        <city>Abadeh</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>73911454611</zip>
        <telephone>+98 71 4438 2925</telephone>
        <email>fatemehnematollahi2@gmail.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Secondary school female students Satisfaction with enrollment.Get a score above 7 of the disability questionnaire Parental consent</inclusion_criteria>
      <agemin>12 years</agemin>
      <agemax>18 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>1. Reluctance to continue research
2. Training in psychological skills in the last 6 months</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>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: After filling out the questionnaire and determining the scores of the questionnaire, people with average to high scores are randomly placed in the intervention group. People who enter the intervention group enter eight training sessions based on mental health topics for one month. Immediately after teaching these students, a self-disability test is performed to assess the degree of self-disability.The content of the sessions is as follows: Session 1: Mental health education, Session 2: Self-knowledge and review of the previous session, Session 3: Positive communication with others and review of previous sessions, Session 4: Optimism and positive thinking, Session 5: Emotional intelligence And review of previous sessions, session 6: independence and autonomy, session 7: personality development and review of previous sessions, session 8: purposeful training in life and review of previous sessions</i_keyword>
      <i_keyword>Control group: People who enter the control group after the self-disability test do not receive any mental health-based training, and after the training, the self-disability test is taken from the intervention group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Disability score in Migli questionnaire. Timepoint: Before the intervention and immediately after the intervention and one month later. Method of measurement: Miley Disability Questionnaire.</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>Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-05-06</approval_date>
        <contact_name>Shiraz university of medical sciences</contact_name>
        <contact_address>Rayati Alley ، Emam Khomaini St، Bahman City Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
