Effectiveness problem solving skills and assertiveness teaching on Self-esteem and mental health in primary schools girls students
Design
Clinical trials have a control group with parallel and randomized groups.
Settings and conduct
Among the girls' schools in the city of Isfahan, several schools will be randomly selected, and after obtaining permission from the school principal and informing students and their parents, if desired, 90 eligible students will be eligible. A random selection will be made of which 30 of them will be randomly assigned to the intervention group using the lottery and will receive six sessions of problem solving and expressing skills training in the presence of the principal at a scheduled appointment by the researcher.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Conscious Consent to Participate in Study by Student and Parents
Non-Inclusion criteria:
Participate in other psychological programs during the intervention period
History of psychiatric use or history of mental illness
Unwillingness to participate in the study
Intervention groups
The 90 samples will be randomly divided into two groups of 30 test subjects and 60 controls. A training session will be conducted for the intervention group, and three sessions of the first session before the training, the last session after the training and three months After the last training session, 28 GHQ questionnaires are completed for coprasmith self-esteem and mental health. The control group did not have a questionnaire, and the questionnaires for them will be completed simultaneously with the intervention group and in the routine classes of the schools.
Main outcome variables
Self-esteem; mental health.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171230038142N9
Registration date:2019-07-07, 1398/04/16
Registration timing:registered_while_recruiting
Last update:2019-07-07, 1398/04/16
Update count:0
Registration date
2019-07-07, 1398/04/16
Registrant information
Name
Khosro Tavakol
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 9134
Email address
tavakol@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-13, 1398/03/23
Expected recruitment end date
2019-07-14, 1398/04/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness problem solving skills and assertiveness teaching on Self-esteem and mental health in primary schools girls students
Public title
Effectiveness problem solving skills and assertiveness teaching on Self-esteem and mental health
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Conscious Consent to Participate in Study by Student and Parents
Exclusion criteria:
Participate in other psychological programs during the intervention period
History of psychiatric use or history of mental illness
Unwillingness to participate in intervention
Age
From 10 years old to 13 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Samples will be selected randomly, by drawing, from the number of students who have criteria for entry into the study. Then 90 randomly selected samples will be divided into two groups of 30 intervention and 60 controls.
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 Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jarib Ave.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2019-06-12, 1398/03/22
Ethics committee reference number
IR.MUI.MED.REC.1398.130
Health conditions studied
1
Description of health condition studied
Self-esteem
ICD-10 code
Z61.3
ICD-10 code description
Events resulting in loss of self-esteem in childhood
2
Description of health condition studied
mental health
ICD-10 code
Z00.4
ICD-10 code description
General psychiatric examination, not elsewhere classified
Primary outcomes
1
Description
Self-esteem
Timepoint
Coprasmith self-esteem questionnaire
Method of measurement
Before the start of the training intervention, immediately after the last training session, three months after the end of the intervention training sessions
2
Description
mental health
Timepoint
Before the start of the training intervention, immediately after the last training session, three months after the end of the intervention training sessions
Method of measurement
Mental health questionnaire 28 GHQ
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 30 randomly selected elementary school students and six sessions with problem solving and expressing skills concepts will be conducted for them, and three sessions of the first session before the training, the last session after the training and three months after the training. The last session of the training on coprasmith self-esteem and GHQ 28 questionnaires will be completed by these students.
Category
Lifestyle
2
Description
Control group:60 schoolchildren who will be randomly selected and will not receive any training, and completion of questionnaires will be conducted simultaneously with the intervention group and in routine school classroom sessions.
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Elementary school girls in Isfahan
Full name of responsible person
Parastoo Golshiri
Street address
Isfahan University of Medical Sciences, Hazar Jarib Street
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 8597
Fax
+98 31 3668 8597
Email
golshiri@hith.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ziba FarajZadegan
Street address
Research Assistant, School of Medicine, Isfahan University of Medical Sciences, Hezar Jarib Street.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 8134
Email
dean@med.mui.ac.ir
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
Parastoo Golshiri
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Public Health/Community Medicine
Street address
Isfahan University of Medical Sciences, Hazar Jarib Street
City
Esfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 8597
Fax
+98 31 3668 8597
Email
golshiri@hith.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Parastoo Golshiri
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Public Health/Community Medicine
Street address
Isfahan University of Medical Sciences, Hazar Jarib Street
City
Esfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 8597
Fax
+98 31 3668 8597
Email
golshiri@hith.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Parastoo Golshiri
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Public Health/Community Medicine
Street address
Isfahan University of Medical Sciences, Hazar Jarib Street
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 8597
Fax
+98 31 3668 8597
Email
golshiri@hith.mui.ac.ir
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
All results are unpublished after two years after the results are published.
When the data will become available and for how long
two years after the results are published.
To whom data/document is available
Doctors, psychologists, psychiatrists and social medicine
Under which criteria data/document could be used
To compare existing conditions with new conditions or comparing girls' education with boys
From where data/document is obtainable
Send an e-mail to golshiri@hith.mui.ac.ir and provide a clear statement on the application and permission of the student deputy and research assistant of the medical school of Isfahan University of Medical Sciences.
What processes are involved for a request to access data/document
Send an email to golshiri@hith.mui.ac.ir and get permission from the student deputy and research deputy of the medical school of Isfahan University of Medical Sciences.