Investigating the Effect of Education Based on Emotional Self-Regulation on the Level of Risk-Taking Among Teenage Girls Dependent on Social Networks in Takestan City in 1403
The aim of this study is to assess the impact of education focused on emotional self-regulation on the risk-taking behavior among teenage girls dependent on social networks in Takestan city in 1403
Design
The study is designed as a randomized controlled clinical trial using cluster randomization and permuted block randomization with block sizes of two classes. It involves 188 female students divided into two groups: an intervention group and a control group.
Settings and conduct
The study will be conducted in secondary schools within Takestan city. Participants will complete Young's Internet Addiction Questionnaire, after which qualified individuals will be randomly assigned to either the test or control groups using cluster and permuted block randomization methods. Before training, both groups will complete demographic questionnaires and the Iranian Teenagers' Risk-Taking Scale.
The intervention group will receive an educational program based on emotional regulation using the Gross model. This will consist of eight group sessions lasting 60 minutes each..
Participants/Inclusion and exclusion criteria
Entry Criteria:
• Must be Iranian.
• Female students aged 16 to 19.
• Dependence on social networks.
• Informed consent from both the individual and their parent to participate in the study.
• Ability to participate in group intervention.
Exclusion Criteria:
• Students attending exceptional schools.
• History of acute or chronic mental illnesses (as per health records).
• Lack of parental and individual consent
Intervention groups
The intervention group will receive an educational program based on emotional regulation using the Gross model.At the end of the study, the control group will be provided with pamphlets summarizing the training content.
Main outcome variables
Vulnerability of adolescent girls
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240514061786N1
Registration date:2024-08-09, 1403/05/19
Registration timing:prospective
Last update:2024-08-09, 1403/05/19
Update count:0
Registration date
2024-08-09, 1403/05/19
Registrant information
Name
Neda Rahmani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3522 6457
Email address
alirahmani1465@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-09-22, 1403/07/01
Expected recruitment end date
2024-12-21, 1403/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the Effect of Education Based on Emotional Self-Regulation on the Level of Risk-Taking Among Teenage Girls Dependent on Social Networks in Takestan City in 1403
Public title
Investigating the Effect of Education Based on Emotional Self-Regulation on the Level of Risk-Taking Among Teenage Girls Dependent on Social Networks in Takestan City in 1403
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Must be Iranian.
Female students aged 16 to 19
Dependence on social networks.
Informed consent from both the individual and their parent to participate in the study
Ability to participate in group intervention
Exclusion criteria:
Students attending exceptional schools
History of acute or chronic mental illnesses (as per health records)
Lack of parental and individual consent
Age
From 16 years old to 19 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
188
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation at the class level will be performed using cluster randomization (Cluster Randomized Trials). Due to the inclusion criterion of social network dependence, blocks will be formed to balance the sample size between the test and control groups. Classes will be grouped into blocks of two, ensuring that the two classes within each block are approximately the same size. We will use the permuted block randomization method. In this method, each block will be randomized using a permutation of the test and control groups. Representing the test group as "A" and the control group as "B," one of the two permutations, AB or BA, will be randomly assigned to the classes within each block.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Qazvin University of Medical Sciences
Street address
Qazvin, Shahid Bahonar Boulevard, Qazvin University of Medical Sciences
City
Qazvin
Province
Qazvin
Postal code
3419759811
Approval date
2024-08-05, 1403/05/15
Ethics committee reference number
IR.QUMS.REC.1403.181
Health conditions studied
1
Description of health condition studied
Risk-Taking Among Teenage Girls Dependent on Social Networks
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Risky behaviors in female adolescents, including:• Tendency toward drug use• Tendency toward alcohol use• Tendency toward smoking• Tendency toward violence• Tendency toward sexual relationships and behaviors• Tendency to engage in relationships with the opposite sex• Tendency to drive dangerously
Timepoint
Before, immediately after and two months later
Method of measurement
Risk scale questionnaire of Iranian adolescents
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: training based on emotional self-regulation with Gross model(1. Situation selection2. Situation modification3. Attention deployment4. Cognitive change5. Response modulation), 8 sessions of 60 minutes for 2 months. Follow-up immediately and two months after the last meeting, the meetings are held by the researcher.
Category
Behavior
2
Description
Control group: Lack of training
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Secondary schools for girls
Full name of responsible person
Neda Rahmani
Street address
Valiasr Street (Aj), secondary girls' schools of the second period of Education Department of Takestan city
City
Takestan
Province
Qazvin
Postal code
3481685315
Phone
+98 28 3522 9513
Email
nedarahmani@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Seyyed Mehdi Mir Hashemi
Street address
Qazvin. - Shahid Ba Hanar Boulevard - Qazvin University of Medical Sciences
City
Qazvin
Province
Qazvin
Postal code
3419759811
Phone
+98 28 3323 7267
Email
fm.mirhashemi@qums.ic.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin University of Medical Sciences
Proportion provided by this source
1
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
Qazvin University of Medical Sciences
Full name of responsible person
Neda Rahmani
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Shahid Bahonar Blvd., Qazvin University of Medical Sciences, Qazvin City
City
Qazvin
Province
Qazvin
Postal code
3419759811
Phone
+98 28 3522 6457
Email
nedarahmani@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Neda Rahmani
Position
دانشجوی کارشناسی ارشد
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Shahid Bahonar Blvd., Qazvin University of Medical Sciences, Qazvin City
City
Qazvin
Province
Qazvin
Postal code
3419759811
Phone
+98 28 3522 6457
Email
nedarahmani@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Neda Rahmani
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Shahid Bahonar Blvd., Qazvin University of Medical Sciences, Qazvin City
City
Qazvin
Province
Qazvin
Postal code
3419759811
Phone
+98 28 3522 6457
Fax
Email
nedarahmani@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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Only a portion of the data is shared
When the data will become available and for how long
5 months
To whom data/document is available
researchers
Under which criteria data/document could be used
research design
From where data/document is obtainable
Neda Rahmani, nedarahmani@gmail.com, zip code 3419759811
What processes are involved for a request to access data/document
The process of sending an email to nedarahmani@gmail.com