The effect of evaluating the educational intervention based on the integrated model of stages of preparation for change (SOC) and the theory of planned behavior on traffic behaviors in 12-14 year-old female students
Determining the effect of the educational intervention based on the integrated model of stages of readiness for change and the theory of planned behavior on safe traffic behaviors in 12–14-year-old female students
Design
A clinical trial with a control group, with parallel groups, randomized using a table of random numbers, phase 1 on 76 patients
Settings and conduct
Conducting an intervention aimed at the impact of education on students' safe traffic behaviors
Selection of schools from the first secondary girls' schools of Bouin Zahra as control and intervention groups using random allocation sampling method and selection of group members using random numbers table
Conducting evaluation results in two stages before and one month after the intervention.
Conducting the pre-test without name decker based on the code by the participants
Conducting training classes by the researcher in 4 training sessions for the test group with a duration of 20 to 50 minutes.
Setting the contents of the educational program based on the structures of the theory of planned behavior
Conducting a post-test one month after the intervention.
Routine training of the control group and evaluation one month later with a post-test
Participants/Inclusion and exclusion criteria
Entry requirements: female students 12-14 years old
Conditions of non-entry: unwillingness to continue voluntary participation
Intervention groups
Educational intervention including 3 stages of planning, implementation and evaluation. Holding 4 training sessions for the intervention group. Evaluation results in two stages before the intervention and one month after the intervention using a questionnaire.
Routine training of the control group and evaluation one month later
Main outcome variables
Average awareness, attitude, intention, behavior
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221222056895N1
Registration date:2023-06-08, 1402/03/18
Registration timing:prospective
Last update:2023-06-08, 1402/03/18
Update count:0
Registration date
2023-06-08, 1402/03/18
Registrant information
Name
Maryam Darziramandi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3453 3629
Email address
m.darziramandi@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-20, 1402/03/30
Expected recruitment end date
2023-07-21, 1402/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of evaluating the educational intervention based on the integrated model of stages of preparation for change (SOC) and the theory of planned behavior on traffic behaviors in 12-14 year-old female students
Public title
The effect of educational intervention of planned behavior on traffic behaviors in female students
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
The willingness and satisfaction of students and their parents to participate in the study
Being in the first 3 stages of preparation for change (according to the answers given to the algorithm of the stages of change)
Studying in 2022-2023, female students in the age range of 12-14 years
Possession of smart mobile phones by students or their parents to send educational posts or virtual education
Exclusion criteria:
Unwillingness to continue volunteering
Suffering from physical and mental disorders and diseases that somehow prevent proper participation in the study (confirmed report by a doctor)
Absence of more than 2 sessions in the training class
Age
From 12 years old to 14 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
76
Randomization (investigator's opinion)
Randomized
Randomization description
Simple random sampling method, one of the schools will be selected as the control group and the other school will be selected as the intervention group. Then a list of 12-14 year old students of each school will be prepared and after complying with the entry and exit criteria using the table of numbers. The members of the control and intervention groups will be randomly selected.
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 University of Medical Sciences, BIvd Shahid Bahonar
City
Qazvin
Province
Qazvin
Postal code
5981134197
Approval date
2023-03-18, 1401/12/27
Ethics committee reference number
IR.QUMS.REC.1401.369
Health conditions studied
1
Description of health condition studied
Safe traffic behavior in 12-14-year-old female students of Buin Zahra city
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Consciousness
Timepoint
Before the intervention, one month after the intervention
Method of measurement
Questionnaire
2
Description
Attitude
Timepoint
Before the intervention, one month after the intervention
Method of measurement
Questionnaire
3
Description
Perceived behavioral control
Timepoint
Before the intervention, one month after the intervention
Method of measurement
Questionnaire
4
Description
Behavioral intention
Timepoint
Before the intervention, one month after the intervention
Method of measurement
Questionnaire
5
Description
Stages of behavior change
Timepoint
Before the intervention, one month after the intervention
Method of measurement
Questionnaire
6
Description
Safe traffic behavior
Timepoint
Before the intervention, one month after the intervention
Method of measurement
Questionnaire
7
Description
Abstract norm
Timepoint
Before the intervention, one month after the intervention
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Age
Timepoint
Before the intervention, one month after the intervention
Method of measurement
Questionnaire
2
Description
Grade
Timepoint
Before the intervention, one month after the intervention
Method of measurement
Questionnaire
3
Description
Parents' occupation
Timepoint
Before the intervention, one month after the intervention
Method of measurement
Questionnaire
4
Description
Parents' education
Timepoint
Before the intervention, one month after the intervention
Method of measurement
Questionnaire
5
Description
The economic situation
Timepoint
Before the intervention, one month after the intervention
Method of measurement
Questionnaire
6
Description
A history of accidents leading to injuries in the family, relatives and friends
Timepoint
Before the intervention, one month after the intervention
Method of measurement
Questionnaire
7
Description
A history of accidents leading to death in the family, relatives and friends
Timepoint
Before the intervention, one month after the intervention
Method of measurement
Questionnaire
Intervention groups
1
Description
Intervention group: Face-to-face training 4 sessions of 45 minutes in 4 weeks with questions and answers along with slides and video playback, the educational content is compiled based on the theory of planned behavior. The educational program will include subjects to increase awareness, attitude, intention, behavior and perceived behavioral control and abstract norms.
Category
Behavior
2
Description
Control group: no action
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
The Revolution Flowers School
Full name of responsible person
Dr. Hadi Morshidi
Street address
Buin Zahra Education Department, Blvd Azadegan
City
Buin Zahra
Province
Qazvin
Postal code
3451667479
Phone
+98 28 3422 9315
Email
medu4636@rayana.ir
2
Recruitment center
Name of recruitment center
The Revolution Message School
Full name of responsible person
Dr. Hadi Morshidi
Street address
Buin Zahra Education Department, Blvd Azadegan
City
Buin Zahra
Province
Qazvin
Postal code
3451667479
Phone
+98 28 3422 9315
Email
medu4636@rayana.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr. Hadi Morshidi
Street address
Qazvin University of Medical Sciencest, Shahid Bahonar Blvd
City
Qazvin
Province
Qazvin
Postal code
5981134197
Phone
+98 28 3336 9581
Email
sph@qums.ac.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
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
Qazvin University of Medical Sciences
Full name of responsible person
Maryam Darzi Ramandi
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Health Promotion
Street address
No. 16، Blvd Sardar Soleimani, corner of Imam Hossein Square
City
Dansfahan
Province
Qazvin
Postal code
3458113594
Phone
028234533629
Email
mmdy6656@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr. Hadi Morshidi
Position
Doctorate in health education
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Qazvin University of Medical Sciences, Blvd Shahid Bahaner
City
Qazvin
Province
Qazvin
Postal code
5981134197
Phone
+98 28 3336 9581
Email
hmorshedi@qums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr. Hadi Morshidi
Position
Specialized doctorate in health education
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Qazvin University of Medical Sciences, Blvd Shahid Bahonar
City
Qazvin
Province
Qazvin
Postal code
5981134197
Phone
+98 28 3336 9581
Email
hmorshedi@qums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available