Design, implementation and performance evaluation of educational package for violence prevention in adolescents and its impact assessment on self-control and social skills of students in Isfahan
Determining the effectiveness of violence prevention education on students' self-control and social skills
Design
Clinical trial with control group with parallel groups, on 70 patients
Settings and conduct
This study is performed in Hazrat Zahra High School in Isfahan. In the intervention group, a violence prevention training package is provided to students and the self-control and social skills questionnaire is filled out for students.
Participants/Inclusion and exclusion criteria
Inclusion criteria: High school students, Willingness to participate in study, Not attending in other educational programs
Exclusion criteria: Students who are outside the desired age range (over 15 years old and under 13 years old), Students who have a known Psychological disorder
Intervention groups
Intervention group: In the intervention group, the training package of violence prevention is provided to students and they are taught during 5 training sessions (45 minutes each session).
Control group: In this group, students are given a self-control and social skills questionnaire to complete. Students are not given any educational package. At the end, the educational package is given to these students as well.
Main outcome variables
Self-control, Social skills
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210426051095N1
Registration date:2021-07-07, 1400/04/16
Registration timing:prospective
Last update:2021-07-07, 1400/04/16
Update count:0
Registration date
2021-07-07, 1400/04/16
Registrant information
Name
fatemeh gholipur
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3282 3658
Email address
gholipur1544@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-09, 1400/05/18
Expected recruitment end date
2021-09-19, 1400/06/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Design, implementation and performance evaluation of educational package for violence prevention in adolescents and its impact assessment on self-control and social skills of students in Isfahan
Public title
Design, implementation and performance evaluation of educational package for violence prevention
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
High school students, willingness to participate in study, not attending in other educational programs
Exclusion criteria:
Students who are outside the desired age range (over 15 years old and under 13 years old), students who have a known psychological disorder.
Age
From 13 years old to 15 years old
Gender
Female
Phase
N/A
Groups that have been masked
Investigator
Data analyser
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the researcher and data analyzer went blind (the task of dividing the participants into two groups of control and intervention was assigned to one of the members of the research team, and the other members and the data collector and analyzer were not aware of this division).
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Hezaar Jarib Street., Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
۷۳۴۶۱-۸۱۷۴۶
Approval date
2020-01-07, 1398/10/17
Ethics committee reference number
IR.MUI.MED.REC.1398.515
Health conditions studied
1
Description of health condition studied
Violent behavior
ICD-10 code
ICD-10-CM
ICD-10 code description
R45.6 is a billable ICD code used to specify a diagnosis of violent behavior
Primary outcomes
1
Description
Self-control
Timepoint
Before the intervention, two months after the intervention
Method of measurement
Tanji self-control questionnaire
Secondary outcomes
1
Description
Social skill
Timepoint
Before intervention, Two months after intervention
Method of measurement
Tanji social skills questionnaire
Intervention groups
1
Description
Intervention group: In the intervention group, the training package of violence prevention is provided to students and they are taught during 5 training sessions (45 minutes each session).
Category
Prevention
2
Description
Control group: In this group, students are given a self-control and social skills questionnaire to complete. Students are not given any educational package. At the end, the educational package is given to these students as well.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrat Zahra High School
Full name of responsible person
Fatemeh Gholipur
Street address
Ashrafzadeh Alley., Ebn e Sina Street
City
Isfahan
Province
Isfehan
Postal code
95095481
Phone
+98 31 5222 3934
Email
gholipur1544@gmail.com
2
Recruitment center
Name of recruitment center
Hazrat Masoumeh High School
Full name of responsible person
Fatemeh Gholipur
Street address
Near Aboozar High School., Red Crescent Street
City
Zarrinshahr
Province
Isfehan
Postal code
8471836376
Phone
+98 31 5223 3657
Email
gholipur1544@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Zahra Amini
Street address
Hezar Jarib Street., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 8123
Email
zahraamini63@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Zahra Amini
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Public Health/Community Medicine
Street address
Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 8123
Email
zahraamini63@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Houri Ansari
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Public Health/Community Medicine
Street address
No. 22, Roshd Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 8123
Email
Houri_ansari@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Zahra Amini
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Public Health/Community Medicine
Street address
No. 22, Roshd Ave., Daneshgah Blvd., Esfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3273 2542
Email
Zahraamini63@gmail.com
Web page address
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
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
All data of individuals in the study can be shared except personal details
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
It will currently be available for researchers working in academic and scientific institutions
Under which criteria data/document could be used
To the extent of reviewing and analyzing data for academic researchers
From where data/document is obtainable
Isfahan School of Social Medicine
What processes are involved for a request to access data/document
By submitting a written request to the director of the School of Social Medicine