Due to the importance of the role of mental health and self-disability in students' academic performance and the lack of intervention studies in this field, it is necessary to do work.
Design
Clinical trial with control and control groups, with parallel groups, single blind, randomized cluster on 54 students.
Settings and conduct
This study was conducted in Abadeh city. Individuals were randomly selected in two schools of Kowsar and Iqbal Lahori that fill in the desired questionnaires which include:
A: Demographic characteristics: This section includes the demographic characteristics of the subjects
B: Academic Disability: Items of the Disability Scale: This questionnaire is designed to assess students' academic achievement goals.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. Secondary female students
2. Having the consent to enter the study.
3. Receive a score above 7 of the disability questionnaire
4. Parental consent
Exclusion criteria:
1. Receive mental health training in the last 6 months
Intervention groups
Intervention group: 27 female high school students who are taught eight sessions of mental health topics
.Control group: 27 female high school students who do not receive mental health education.
Main outcome variables
Determining the self-disability score of female high school students in Abadeh city
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200708048063N1
Registration date:2020-11-02, 1399/08/12
Registration timing:registered_while_recruiting
Last update:2020-11-02, 1399/08/12
Update count:0
Registration date
2020-11-02, 1399/08/12
Registrant information
Name
Fatemeh Nematolahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 4438 2925
Email address
f_nematollahi@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-21, 1398/01/01
Expected recruitment end date
2021-03-19, 1399/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of mental health education on self-handicapping of secondary school girl students in Abadeh, 2019-2020
Public title
The effect of mental health education on self-disability of female students.
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Secondary school female students Satisfaction with enrollment.Get a score above 7 of the disability questionnaire Parental consent
Exclusion criteria:
1. Reluctance to continue research
2. Training in psychological skills in the last 6 months
Age
From 12 years old to 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Based on the formula for determining the average sample size with an error of 5% and a power of 90% and an absolute error of 5 units, the sample size of at least 55 people was calculated, which is used according to the drop of 60 people. Of these 4 schools, 2 schools are randomly selected as the intervention group and the other 2 schools as the control group. Also, a total of 60 people are randomly selected and included in the study.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, students who were randomly placed in the control and control groups were kept in the blind group. People in the control group were unaware of the intervention on individuals in the control group. They do not have education. They do not know about the education of the control group, which is 27 other students.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz university of medical sciences
Street address
Rayati Alley ، Emam Khomaini St، Bahman City
City
Shiraz
Province
Fars
Postal code
73911-39183
Approval date
2020-05-06, 1399/02/17
Ethics committee reference number
IR.SUMS.REC.1399.299
Health conditions studied
1
Description of health condition studied
Check the degree of self-disability
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Disability score in Migli questionnaire
Timepoint
Before the intervention and immediately after the intervention and one month later.
Method of measurement
Miley Disability Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: After filling out the questionnaire and determining the scores of the questionnaire, people with average to high scores are randomly placed in the intervention group. People who enter the intervention group enter eight training sessions based on mental health topics for one month. Immediately after teaching these students, a self-disability test is performed to assess the degree of self-disability.The content of the sessions is as follows: Session 1: Mental health education, Session 2: Self-knowledge and review of the previous session, Session 3: Positive communication with others and review of previous sessions, Session 4: Optimism and positive thinking, Session 5: Emotional intelligence And review of previous sessions, session 6: independence and autonomy, session 7: personality development and review of previous sessions, session 8: purposeful training in life and review of previous sessions
Category
Other
2
Description
Control group: People who enter the control group after the self-disability test do not receive any mental health-based training, and after the training, the self-disability test is taken from the intervention group.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Abadeh city girls' secondary high schools
Full name of responsible person
Fatemeh Nematolahi
Street address
Emam Khomeini st،Bahman، Abadeh
City
Abadeh
Province
Fars
Postal code
7391145416
Phone
+98 71 4438 2925
Fax
Email
fatemehnematollahi2@gmail.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Roksana Janghorban
Street address
Emam Khomeini St،Bahman، Abadeh
City
Abadeh
Province
Fars
Postal code
7391145416
Phone
+98 71 4438 2925
Email
fatemehnematollahi2@gmail.com
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
Fatemeh Nematollahi2@gmail.com
Position
Senior Nursing Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Emam Khomini St ، Bahman،Abadeh
City
Abadeh
Province
Fars
Postal code
73911454611
Phone
+98 71 4438 2925
Email
fatemehnematollahi2@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Fatemeh Nematolali
Position
Senior Nursing Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Emam Khomini St ، Bahman،Abadeh
City
Abadeh
Province
Fars
Postal code
73911454611
Phone
+98 71 4438 2925
Email
fatemehnematollahi2@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Fatemeh Nematolali
Position
Senior Nursing Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Emam Khomini St ، Bahman،Abadeh
City
Abadeh
Province
Fars
Postal code
73911454611
Phone
+98 71 4438 2925
Email
fatemehnematollahi2@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
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
Title and more details about the data/document
After the intervention and data analysis, the results of the study will be shared after identifying the participants.
When the data will become available and for how long
from 1400
To whom data/document is available
All researchers
Under which criteria data/document could be used
If there is a letter from the ethics committee and permission of the ethics committee.
From where data/document is obtainable
--
What processes are involved for a request to access data/document