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Assessing Effectiveness of Maternal Mental Health Literacy Improvement Program on Mental Health Status of Children

Protocol summary

Study aim
The present study aims to "examine the effectiveness of mental health promotion programs for improving the mental health status of children" in girls' schools in Tabriz.
Design
In the first phase of the study, an initial assessment will be carried out in the studied population and the area where students have high prevalence of mental health problems will be selected as the study population.Then, in the mentioned area, the population selected from homogeneous regions Then, they will be divided into two groups of intervention and control randomly. Finally, the design, implementation, and evaluation of the intervention program will be carried out.
Settings and conduct
This study will be conducted among high school students of the eighth grade.
Participants/Inclusion and exclusion criteria
Inclusion criteria - Student girls who are studying at the eighth grade. -Mothers of female students attending school at the eighth grade - Girl students studying at the eighth grade who provided written consent from their parents. Exclusion criteria - Girls who are undergoing psychiatric treatment due to severe psychological illnesses, including schizophrenia, delusional disorders, depression and bipolar disorder. - A girl whose mothers are illiterate. - The unwillingness of each student or mother to continue cooperation
Intervention groups
Educating mothers of the eighth grade students and increasing their mental health literacy in them with an emphasis on some aspects of mental health literacy (Intervention group). Mothers of the 8th grade students without training (control group)
Main outcome variables
Mental health, Happiness, Social acceptance, Aggression, Mental health literacy, Loneliness. All variables of the study will be measured through standard self-reporting questionnaires.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20181004041227N1
Registration date: 2018-11-05, 1397/08/14
Registration timing: prospective

Last update: 2018-11-05, 1397/08/14
Update count: 0
Registration date
2018-11-05, 1397/08/14
Registrant information
Name
Haleh Hezomi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3334 0309
Email address
hezomih@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-22, 1397/09/01
Expected recruitment end date
2019-01-21, 1397/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessing Effectiveness of Maternal Mental Health Literacy Improvement Program on Mental Health Status of Children
Public title
Maternal Mental Health Literacy Improvement Program on Mental Health Status of Children
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
The total number of students who are studying at the eighth grade. Total student girls who have provided written consent from their parents. The whole mothers of female students are in the eighth grade of education.
Exclusion criteria:
Girls who are psychiatric patients due to severe psychological illnesses, including schizophrenia, delusional disorders, depression and bipolar disorder. Unwillingness of each student or mother to continue cooperation Girls whose mothers are illiterate.
Age
No age limit
Gender
Female
Phase
2
Groups that have been masked
  • Participant
Sample size
Target sample size: 128
Randomization (investigator's opinion)
Randomized
Randomization description
In the first phase of the study, an initial assessment will be carried out in the studied population and the area where students have high prevalence in terms of mental health problems will be selected as the study population.Then, in the mentioned area, the population selected from homogeneous regions is then divided into two groups of intervention and control randomly(Simple randomization). Stata software will be used for random assignment Then, the design, implementation, and evaluation of the intervention program will be carried out.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, participants in both groups will be blind. So that none of the intervention and control groups will know which one of the groups belongs, and for this purpose the intervention and control group will be selected from separate schools.
Placebo
Not used
Assignment
Parallel
Other design features
The innovation of this study is due to the lack of studies on mental health literacy in the field of schools and students in foreign and domestic research texts, and in view of the fact that in studies conducted on the role and impact of improving the mental health of parents on improving the mental health of students not mentioned.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committee Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences Faculty of Health Sciences Department of Health Education and Promotion Attar of Nishapuri St, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5154966151
Approval date
2018-09-24, 1397/07/02
Ethics committee reference number
IR.TBZMED.REC.1397.527

Health conditions studied

1

Description of health condition studied
Mental Health Literacy Status
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Mental health status of children-Happiness-Social acceptance -Aggression-Loneliness-Mental health literacy
Timepoint
One and twelve weeks after the intervention
Method of measurement
questionnaire

Secondary outcomes

1

Description
Mental health-Happiness-Social acceptance-Aggression -Loneliness
Timepoint
3 months after intervention
Method of measurement
Questionnaire

Intervention groups

1

Description
Intervention group: Mothers whose children are studying at the eighth grade.Training to increase maternal mental health literacy.The training will be for one month and will be two sessions per week, each session lasts for 45 minutes.Training for 128 people will be delivered in the form of lectures.
Category
Diagnosis

2

Description
Control group: 128 mothers whose children are in the 8th grade. They will not be trained.
Category
Diagnosis

Recruitment centers

1

Recruitment center
Name of recruitment center
School
Full name of responsible person
Haleh Hezomi
Street address
Tabriz University of Medical Sciences Faculty of Health Sciences Department of Health Education and Promotion Attar of Nishapuri St, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
14711-IRAN
Phone
+98 41 3334 0309
Fax
Email
hhezomih@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Asghar Mohammadpoorasl
Street address
Department of Epidemiology and Biostatistics, School of Health, Tabriz University of Medical Sciences, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
14711-IRAN
Phone
+98 41 3334 4731
Fax
Email
ampoorasl@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
50
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
Tabriz University of Medical Sciences
Full name of responsible person
Hamid Allahverdipour
Position
Professor of Health Education and Promotion
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Tabriz University of Medical Sciences Faculty of Health Sciences Department of Health Education and Promotion Attar of Nishapuri St, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
14711-IRAN
Phone
+98 41 3334 0309
Email
Allahverdipourh@tbzmed.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Hamid Allahverdipour
Position
Professor of Health Education and Promotion
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Tabriz University of Medical Sciences Faculty of Health Sciences Department of Health Education and Promotion Attar of Nishapuri St, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
14711-IRAN
Phone
+98 41 3334 0309
Email
Allahverdipourh@tbzmed.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Haleh Hezomi
Position
Phd Candidat
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
Tabriz University of Medical Sciences Faculty of Health Sciences Department of Health Education and Promotion Attar of Nishapuri St, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
14711-IRAN
Phone
+98 41 3334 0309
Email
hhezomih@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
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
In the form of dissertation and publication of the article.
When the data will become available and for how long
3 months after intervention
To whom data/document is available
Research colleagues
Under which criteria data/document could be used
To improve mental health of students
From where data/document is obtainable
Principal Investigator
What processes are involved for a request to access data/document
University-Department of Education
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