<?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>IRCT20230603058372N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-06-05</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of educational intervention on mental health literacy</public_title>
      <acronym></acronym>
      <scientific_title>The effect of educational intervention based on social media on mental health literacy of High school students</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-06-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>204</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/70475</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Other design features: Considering that our research group does not do any intervention for the control group and our focus will be on the intervention group, the "other items" option seems more suitable than other allocation options, Randomization description: A randomized controlled trial study without blinding, the study population of which will be secondary school students. Random stratified sampling method is used. First, an education district is randomly selected from all the education districts, and then, taking into account assimilation, half of the schools are randomly selected for the intervention group (4 schools) and the other half for the control group (4 schools). .
We will use a sequence of random numbers generated by (random.org) to assign each school a number from 1 to 2. Then we sorted the list of schools according to the assigned number and divided them into two groups: schools with number 1 were placed in the intervention group and schools with number 2 were placed in the control group. This ensured that each school had an equal chance of being placed in both groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Mental health literacy and attitude towards help seeking.</hc_freetext>
      <i_freetext>Intervention 1: "Intervention group": Our intended intervention will be a researcher-made intervention based on social media, which will be designed based on the core components of The Guide educational package. Educational content called The Guide has been prepared to help increase students' mental health literacy and is targeted for use in the first and second secondary levels. Mental health literacy has four main components: 1) understanding how to optimize and maintain mental health 2) understanding mental disorders and their treatment 3) reducing stigma 4) increasing the effectiveness of seeking help (knowing when and where to seek help and having the necessary skills to promoting self-care and how to receive good care). This package will help prepare students for success in each of these areas. We will validate the educational content developed by the researcher based on The Guide educational package using an elite panel including experts in the field of psychology and health education and health promotion. Then educational materials will be sent to the study population through available social media (Rubika and Eita) and we will deepen the presented materials through questions and answers, educational videos and stories. Intervention 2: "Control group": will receive routine care.</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:
raw data/Publication is permitted by removing all personally identifiable information.

When:
The access period starts 1 month after the results are published

To whom:
Free access

Conditions:
There are no special conditions

Where to obtain:
Abخuzar Nazari
abozarnazari368@gmail.com
09167255838

How to obtain:
Immediately after the call

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Abouzar Nazari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Saadat dead end, 16 Azar St., Keshavarz Blvd.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1417653761</zip>
        <telephone>+98 21 8670 5503</telephone>
        <email>abozarnazari368@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Gholamreza Garmaroudi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Health Education and Promotion, Faculty of Health, Porsina St.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1417653761</zip>
        <telephone>+98 21 8670 5503</telephone>
        <email>garmaroudi@tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>A male student of the second secondary level
Smartphone access
Willingness to cooperate in research</inclusion_criteria>
      <agemin>12 years</agemin>
      <agemax>19 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Have a diagnosed mental disorder or be undergoing mental health treatment
do not have parental consent to participate in the study
Have previously participated in a similar educational intervention</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>depress</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>"Intervention group": Our intended intervention will be a researcher-made intervention based on social media, which will be designed based on the core components of The Guide educational package. Educational content called The Guide has been prepared to help increase students' mental health literacy and is targeted for use in the first and second secondary levels. Mental health literacy has four main components: 1) understanding how to optimize and maintain mental health 2) understanding mental disorders and their treatment 3) reducing stigma 4) increasing the effectiveness of seeking help (knowing when and where to seek help and having the necessary skills to promoting self-care and how to receive good care). This package will help prepare students for success in each of these areas. We will validate the educational content developed by the researcher based on The Guide educational package using an elite panel including experts in the field of psychology and health education and health promotion. Then educational materials will be sent to the study population through available social media (Rubika and Eita) and we will deepen the presented materials through questions and answers, educational videos and stories.</i_keyword>
      <i_keyword>"Control group": will receive routine care.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Mental health literacy. Timepoint: Before, 3 and 6 months after the intervention. Method of measurement: Mental health literacy questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Attitude towards professional psychological help. Timepoint: Before, 3 and 6 months after the intervention. Method of measurement: Questionnaire of attitude towards professional psychological help - short form.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-05-27</approval_date>
        <contact_name>Faculty of Health and Paramedicine - Tehran University of Medical Sciences (Research Ethics Committe</contact_name>
        <contact_address>Saadat dead end, 16 Azar St., Keshavarz Blvd., Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
