Protocol summary

Study aim
Investigating the effect of a social cognitive theoty based educational intervention on mobile use behavior and its determinants among female high school students
Design
A clinical trial with parallel groups (intervention and control) with a sample size of 110 people in each group, which are randomly selected in a cluster. After determining the second secondary schools, 2 schools are randomly selected and an experimental or control group is assigned to each school in a simple random manner.
Settings and conduct
The research environment in this study is public high schools for girls in Ewaz
Participants/Inclusion and exclusion criteria
The female student is studying in the second secondary level unwillingness to participation; Parents' disagreement of her participation
Intervention groups
After the pre-test, training sessions for the intervention group will be held during 6 training sessions for 2 months, and they will receive the necessary training, one month after the end of the training intervention for each training group, the post-test will be completed The same questionnaires will be done before the intervention. The control group will not receive any intervention. However, after the intervention and the collection of post-test results, all educational documents and taught content will be available to the members of the control group
Main outcome variables
Knowledge scores, outcome expectations scores, self-efficacy scores, self-control scores, behavioral intention scores, behavior scores

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20110423006261N20
Registration date: 2023-02-15, 1401/11/26
Registration timing: registered_while_recruiting

Last update: 2023-02-15, 1401/11/26
Update count: 0
Registration date
2023-02-15, 1401/11/26
Registrant information
Name
Mohammad Hussein Kaveh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 1725 1001
Email address
kaveh@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-24, 1401/07/02
Expected recruitment end date
2023-04-19, 1402/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of a social cognitive theory based educational intervention on mobile use behavior and its determinants among female high school students; an educational cluster randomized controlled trial
Public title
Investigating the effect of a social cognitive theory based educational intervention on mobile use behavior
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
The student participating in the plan must have a smartphone for more than one year and have proper access to it. The student is studying in the second secondary level
Exclusion criteria:
The student's unwillingness to participate in the study Unwillingness of the student's family to participate in the study
Age
From 15 years old to 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 220
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, a simple randomization method is used, intervention and control group allocation is done using a lottery method, and the number of 2 schools, which are the clusters, are selected from among 8 girls' secondary schools in the city of Ewaz. The names of all 8 schools are written on a piece of paper and we randomly pick one. The school that was chosen first will be the control group and the second school will be the intervention group. Again, a lottery is drawn between individuals or couples in each school. From each school, 110 students whose student numbers are odd or even are selected for the control or intervention group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
In order to prevent information leakage, random allocation is doing in level of schools not students.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Vice chancellor for research, seventh floor, Shiraz University Center Building, Zand Avenue
City
Shiraz
Province
Fars
Postal code
7134814336
Approval date
2022-10-03, 1401/07/11
Ethics committee reference number
IR.SUMS.SCHEANUT.REC.1401.094

Health conditions studied

1

Description of health condition studied
mobile use behavior
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
behavior
Timepoint
Before the intervention and 4 weeks after intervention
Method of measurement
Standardized pre-made questionnaire

2

Description
Knowledge
Timepoint
Before the intervention and 4 weeks after intervention
Method of measurement
Standardized pre-made questionnaire

3

Description
Intention
Timepoint
Before the intervention and 4 weeks after intervention
Method of measurement
Standardized pre-made questionnaire

Secondary outcomes

1

Description
outcome expectations
Timepoint
Before the intervention and 4 weeks after intervention
Method of measurement
Standardized pre-made questionnaire

2

Description
Efficacy
Timepoint
Before the intervention and 4 weeks after intervention
Method of measurement
Standardized pre-made questionnaire

3

Description
Self-control
Timepoint
Before the intervention and 4 weeks after intervention
Method of measurement
Standardized pre-made questionnaire

Intervention groups

1

Description
Intervention group: 110 students of the 10th, 11th and 12th grades of public high schools for girls are selected according to the sampling process, after the pre-test using a pre-made questionnaire, the educational intervention is implemented in the form of at least 6 educational sessions of 30-45 minutes. to be The educational title includes general information about the virtual space and mobile phones, the advantages and disadvantages of mobile phones, ways to overcome excessive use of mobile phones, ways to evaluate yourself about the duration of using mobile phones, choosing the right media and how to sit correctly and work with Mobile and tablet. These topics are based on reliable and related sources. Overall strategy include interactive methods such as interactive lectures, small group techniques, group discussion, questions and answers and home based assignments and self-teaching materials for pamphlets and booklets that runs by the researcher. Also if it is possible to expand and deepen learning in cyberspace, a group is created for text and video and audio messages. In addition, the duration and number of training sessions may increase based on the capacity, the willingness, the conditions of the participants in the class and other factors. Six weeks after the completion of the training, a post-test will be held.
Category
Behavior

2

Description
Control group: students in control group will experience no intervention but only routine school curricula.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Shiraz Girl High Schools
Full name of responsible person
Kosar Zarebi
Street address
Health Education and Health Promotion Group, School of Public Health, Razi Blvd, Shiraz, Iran.
City
Shiraz
Province
Fars
Postal code
14336 71348
Phone
+98 71 5233 1895
Email
k.zarebi75@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
DR Syed Basir Hashemi
Street address
Vice chancellor for research, seventh floor, Shiraz University Center Building, Zand Avenue
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3725 1001
Email
kaveh@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Hossein Kaveh
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Health Education and Health Promotion Group, School of Public Health, Razi Blvd, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3725 1001
Email
kaveh@sums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Hossein Kaveh
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Health Education and Health Promotion Group, School of Public Health, Razi Blvd, Shiraz, Iran.
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3725 1001
Email
kaveh@sums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Kosar Zarebi
Position
Master Student of Health Education and Health Promotion
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
Health Education and Health Promotion Group, School of Public Health, Razi Blvd, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 5233 1895
Email
k.zarebi75@yahoo.com

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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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