Protocol summary

Study aim
This study aims to design, implement, and evaluate a Social Cognitive Theory-based educational intervention using a critical thinking approach to improve mental health literacy, resilience, and help-seeking behaviors among adolescent girls in Bandar Abbas, Iran.
Design
This mixed-methods study consists of four phases: qualitative exploration, instrument development and psychometric evaluation, a cross-sectional survey, and a quasi-experimental controlled trial. In the intervention phase, 170 students will be assigned to intervention (n=85) and control (n=85) groups.
Settings and conduct
The study will be conducted in Bandar Abbas, Iran. Semi-structured interviews will explore factors related to mental health literacy, resilience, and help-seeking behaviors. Findings will inform questionnaire development and validation. A cross-sectional study will then be conducted, followed by evaluation of the intervention using a pretest–posttest design with a control group.
Participants/Inclusion and exclusion criteria
Participants will be female secondary school students in Bandar Abbas. Inclusion criteria are school enrollment, willingness to participate, and informed consent. Students with diagnosed psychiatric disorders or those receiving psychiatric treatment will be excluded.
Intervention groups
The intervention group will receive an eight-session educational program based on Social Cognitive Theory and critical thinking principles, delivered through face-to-face and virtual methods. Interactive strategies, including group discussion, problem-solving, role-playing, and scenario-based activities, will be used. The control group will receive the educational materials after study completion.
Main outcome variables
Primary outcomes include improved mental health literacy, resilience, and help-seeking behaviors among adolescent girls.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20260610069742N1
Registration date: 2026-06-29, 1405/04/08
Registration timing: prospective

Last update: 2026-06-29, 1405/04/08
Update count: 0
Registration date
2026-06-29, 1405/04/08
Registrant information
Name
elham ahmadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 76 3222 8134
Email address
elham.ahmadizade@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-09-23, 1405/07/01
Expected recruitment end date
2026-10-22, 1405/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
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
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
Purpose
Other
Inclusion/Exclusion 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
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
Age
From 13 years old to 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 170
Randomization (investigator's opinion)
Randomized
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.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Hormozgan University of Medical Sciences
Street address
Bandar Abbas, the beginning of Imam Hossein Boulevard, Hormozgan University of Medical Sciences Campus, Research and Technology Office, Building No. 2, 3rd Floor
City
Bandarabbas
Province
Hormozgan
Postal code
7919916753
Approval date
2026-05-23, 1405/03/02
Ethics committee reference number
IR.HUMS.REC.1405.032

Health conditions studied

1

Description of health condition studied
Mental health literacy, resilience, and help-seeking behaviors
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
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.

Secondary outcomes

1

Description
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.

Intervention groups

1

Description
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.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
مدارس متوسطه دخترانه تحت پوشش اداره کل آموزش و پرورش شهر بندرعباس، استان هرمزگان، ایران
Full name of responsible person
elham ahmadizadefini
Street address
سه راه برق کوچه بسیج 20
City
Bandarabbas
Province
Hormozgan
Postal code
7913873419
Phone
+98 917 360 0564
Email
elham.ahmadizade@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Dr.Shahram Zare
Street address
Bandar Abbas - Beginning of Imam Hossein Boulevard - University of Medical Sciences Campus - Vice President for Research and Technology
City
Bandarabbas
Province
Hormozgan
Postal code
7919692004
Phone
+98 76 3128 1680
Fax
+98 76 3371 0393
Email
resv@hums.ac.ir
Web page address
https://resv.hums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bandare-abbas University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Elham Ahmadizadefini
Position
کارمند دانشگاه علوم پزشکی هرمزگان
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Three-way street
City
Bandarabbas
Province
Hormozgan
Postal code
7913873419
Phone
+98 76 3222 8134
Email
elham.ahmadizade@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Elham Ahmadizadefini
Position
Employee of Hormozgan University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
سه راه برق
City
Bandarabbas
Province
Hormozgan
Postal code
7913873419
Phone
+98 76 3222 8134
Email
elham.ahmadizade@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Elham Ahmadizadefini
Position
کارمند دانشگاه علوم پزشکی هرمزگان
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Three-way street
City
Bandarabbas
Province
Hormozgan
Postal code
7913873419
Phone
+98 76 3222 8134
Email
elham.ahmadizade@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All study data may be shared after de-identification and anonymization of participant information.
When the data will become available and for how long
Access to the de-identified dataset will be available beginning 6 months after publication of the primary study results.
To whom data/document is available
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.
Under which criteria data/document could be used
Access to the data will be granted subject to the protection of participant confidentiality and the reasonableness of the request.
From where data/document is obtainable
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
What processes are involved for a request to access data/document
After submission of a request via email and obtaining permission from the study supervisors, the requested information will be provided to the applicant.
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