<?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>IRCT20260610069742N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-06-29</date_registration>
      <primary_sponsor>Bandare-abbas University of Medical Sciences</primary_sponsor>
      <public_title>Design, Implementation, and Evaluation of a Social Cognitive Theory–Based Mental Health Literacy Promotion Program with a Critical Thinking Approach to Enhance Resilience and Help-Seeking Behaviors among Adolescent Girls</public_title>
      <acronym></acronym>
      <scientific_title>Design, Implementation, and Evaluation of a Social Cognitive Theory–Based Mental Health Literacy Promotion Program with a Critical Thinking Approach to Enhance Resilience and Help-Seeking Behaviors among Adolescent Girls</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>170</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/90825</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Factorial, Purpose: Other, Randomization description: In this stage, first, the government secondary schools for girls in Bandar Abbas city are identified. Then, two schools are randomly selected as the intervention group and two schools as the control group. Among the eligible students in each school, the samples are voluntarily and conveniently included in the study.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Mental health literacy, resilience, and help-seeking behaviors.</hc_freetext>
      <i_freetext>Intervention group: The intervention consists of a structured educational program based on Social Cognitive Theory (SCT) and a critical thinking approach, delivered within the school setting. The intervention content will be developed using findings from the qualitative phase and baseline assessment results.Eligible participants assigned to the intervention group will be invited by the principal investigator, who will explain the study objectives, intervention procedures, and ethical considerations before obtaining informed consent. The intervention will then be implemented according to a predefined protocol developed by a health education and health promotion specialist in collaboration with a psychologist.The program will include eight educational sessions delivered through a combination of face-to-face and virtual formats (social media platforms). Face-to-face sessions will be conducted approximately once per week, with each session lasting about 45 minutes. Educational strategies will emphasize active learning methods, including group discussions, problem-solving activities, role-playing, and scenario-based learning. Educational posters and pamphlets will also be used to reinforce key messages.The intervention is designed to improve mental health literacy, strengthen resilience, and promote appropriate help-seeking behaviors among adolescent girls. Participants in the control group will receive the educational materials after completion of the study..</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:
All study data may be shared after de-identification and anonymization of participant information.

When:
Access to the de-identified dataset will be available beginning 6 months after publication of the primary study results.

To whom:
Access requests should be submitted via email. De-identified data will be shared with qualified researchers following approval by the principal investigator and supervising faculty members.

Conditions:
Access to the data will be granted subject to the protection of participant confidentiality and the reasonableness of the request.

Where to obtain:
Elham Ahmadizadeh
PhD Candidate, Department of Health Education and Health Promotion
Email: elham.ahmadizade@gmail.com
Supervising Investigator
Dr. Zahra Hosseini
Email: hosseinishirin@ymail.com

How to obtain:
After submission of a request via email and obtaining permission from the study supervisors, the requested information will be provided to the applicant.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Elham Ahmadizadefini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Three-way street</address>
        <city>Bandarabbas</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7913873419</zip>
        <telephone>+98 76 3222 8134</telephone>
        <email>elham.ahmadizade@gmail.com</email>
        <affiliation>Bandare-abbas University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Elham Ahmadizadefini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>سه راه برق</address>
        <city>Bandarabbas</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7913873419</zip>
        <telephone>+98 76 3222 8134</telephone>
        <email>elham.ahmadizade@gmail.com</email>
        <affiliation>Bandare-abbas University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>1. Studying in girls' secondary schools in Bandar Abbas2. Being selected in the cross-sectional stage and eligible to enter the intervention phase3. Willingness to participate in the educational program and signing an informed consent form4. Obtaining consent from parents/legal guardians</inclusion_criteria>
      <agemin>13 years</agemin>
      <agemax>18 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>1. Diagnosed psychiatric disorders or receiving concurrent psychiatric treatment (based on self-report or school records)2. Failure to complete pre-test or post-test questionnaires3. Failure to attend more than one intervention session4. Dropping out of school, transferring from school, or changing school location during the intervention5. Voluntary withdrawal from participation at any stage of the intervention phase</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>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The intervention consists of a structured educational program based on Social Cognitive Theory (SCT) and a critical thinking approach, delivered within the school setting. The intervention content will be developed using findings from the qualitative phase and baseline assessment results.Eligible participants assigned to the intervention group will be invited by the principal investigator, who will explain the study objectives, intervention procedures, and ethical considerations before obtaining informed consent. The intervention will then be implemented according to a predefined protocol developed by a health education and health promotion specialist in collaboration with a psychologist.The program will include eight educational sessions delivered through a combination of face-to-face and virtual formats (social media platforms). Face-to-face sessions will be conducted approximately once per week, with each session lasting about 45 minutes. Educational strategies will emphasize active learning methods, including group discussions, problem-solving activities, role-playing, and scenario-based learning. Educational posters and pamphlets will also be used to reinforce key messages.The intervention is designed to improve mental health literacy, strengthen resilience, and promote appropriate help-seeking behaviors among adolescent girls. Participants in the control group will receive the educational materials after completion of the study.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The primary outcomes are mental health literacy, resilience, and help-seeking behaviors among adolescent girls. Social Cognitive Theory constructs related to these outcomes, including knowledge, self-efficacy, collective efficacy, outcome expectations, observational learning, normative beliefs, social support, barriers and opportunities, behavioral skills, behavioral intentions, and reinforcements, will also be assessed. Timepoint: Outcome measures will be assessed at three time points: baseline (pre-intervention), immediately after the intervention, and three months after completion of the intervention. Method of measurement: Mental health literacy will be measured using the Mental Health Literacy Scale (MHLS), resilience will be assessed using the Connor–Davidson Resilience Scale (CD-RISC), and help-seeking behaviors will be evaluated using the Actual Help-Seeking Questionnaire (AHSQ). In addition, SCT constructs will be measured using a researcher-developed questionnaire designed and psychometrically evaluated based on qualitative findings and the Social Cognitive Theory framework.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Secondary outcomes include increased student participation in supportive and mental health–related activities, enhanced involvement and support of school staff in mental health literacy promotion programs, and improved peer support for mental health and help-seeking behaviors. Timepoint: Secondary outcomes will be assessed at three time points: baseline (pre-intervention), immediately after the intervention, and three months after the intervention. Method of measurement: Student participation in supportive activities, peer support, and school staff involvement will be assessed using relevant sections of a researcher-developed questionnaire based on Social Cognitive Theory. The instrument will be developed from qualitative findings and its validity and reliability will be established before implementation. In addition, participation in educational sessions and supportive activities will be monitored using attendance and participation records.</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>Bandare-abbas University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2026-05-23</approval_date>
        <contact_name>Ethics committee of Hormozgan University of Medical Sciences</contact_name>
        <contact_address>Bandar Abbas, the beginning of Imam Hossein Boulevard, Hormozgan University of Medical Sciences Campus, Research and Technology Office, Building No. 2, 3rd Floor Bandarabbas Hormozgan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
