This study will be designed to investigate the effectiveness of social skills training on students' mental health as a single-blind clinical trial.
Design
This study will be designed to investigate the effectiveness of social skills training on students' mental health as a clinical trial. The study population includes 21 third-grade elementary students studying at the non-profit school of Baran Andisheh in Rasht. This is a semi-experimental study using pre-test and post-test. Students will be selected by a psychiatrist and by questionnaires. The participants will be included in the study by easy and convenience sampling method after receiving informed consent from parents and teachers by considering criteria of entering and leaving the study. After sampling, samples will be assigned to the intervention group. Parents' dissatisfaction or the history of participation in other social skills training programs will cause to leave the research process. The intervention process will be taken place in 10 sessions of 90 minutes. The effectiveness of treatment after the end of the school year will be assessed based on the score obtained from the strengths and difficulties questionnaire (SDQ) for assessing mental health and Matson evaluation of social skills.
Settings and conduct
For social skills training to students, the relevant teacher will be used that each week is in relation with them. The content of the social skills training protocol include the Teacher Guidebook and the Child Workbook. This package will be prepared to provide a comprehensive, simple, functional and appropriate with features of Iranian children of 6 to 12 years old. This protocol includes a step-by-step application guide with examples appropriate with age of child for the performer that can be a teacher or training adviser from diploma level to high degrees and includes 10 skills. 1- Self-efficacy 2- Empathy 3. Effective communication 4. Creative thinking 5. Critical thinking 6. Problem-solving 7. Management of emotions 8. Conflict with stress 9. Decision-making. 10. Dare skill and telling No. (Introduction of Social Skills Training Package is presented in the Appendix). For elimination of the possibility of any bias due to the knowledge of patients or physicians evaluation of the results, and possible impact on the outcomes of research a single blind study will be performed, the participants will be blind to the intervention type.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Students of elementary school in Rasht city aged 9 to 11 years old
Exclusion criteria:
Children whose parents do not consent to participate in the research
Children with a history of participation in other programs of social skills training
Intervention groups
The training is provided by the program executives through 10 sessions of 90 minutes with the presence of a teacher in the class. The teacher is allowed to use these methods during the week if necessary. At the end of the school year, the questionnaires will be filled by parents again and they will be evaluated. The goal of the sessions is to increase social skills in school and home environments and reduce their problematic behaviors. The methods of cognitive behavioral skills and positive reinforcement will be used. Group practice methods will be used in the classroom and homework will be given to them for training. The content of the social skills training protocol include the Teacher Guidebook and the Child Workbook. This package will be prepared to provide a comprehensive, simple, functional and appropriate with features of Iranian children of 6 to 12 years old. This protocol includes a step-by-step application guide with examples appropriate with age of child for the performer that can be a teacher or training adviser from diploma level to high degrees and includes 10 skills. 1- Self-efficacy 2- Empathy 3. Effective communication 4. Creative thinking 5. Critical thinking 6. Problem-solving 7. Management of emotions 8. Conflict with stress 9. Decision-making. 10. Dare skill and telling No. (Introduction of Social Skills Training Package is presented in the Appendix.)
Main outcome variables
Mental Health
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110806007237N3
Registration date:2018-03-13, 1396/12/22
Registration timing:registered_while_recruiting
Last update:2018-03-13, 1396/12/22
Update count:0
Registration date
2018-03-13, 1396/12/22
Registrant information
Name
Maryam Kousha
Name of organization / entity
Guilan University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 13 1666 1163
Email address
m-kousha@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-29, 1396/11/09
Expected recruitment end date
2019-01-29, 1397/11/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical Trial of the Effectiveness of Social Skills Training on Students' Mental Health
Public title
Clinical Trial of the Effectiveness of Social Skills Training on Students' Mental Health
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Students of elementary school in Rasht city aged 9 to 11 years old
Exclusion criteria:
Children whose parents do not consent to participate in the research
Children with a history of participation in other programs of social skills training
Age
From 9 years old to 11 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
21
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
This pilot will be conducted in a third-grade elementary school in the first semester. Initially, a correspondence will be provided with education for the implementation of the project. After giving enough explanations about the objectives of the project and collected confidential documents from the questionnaires, informed consent will be received from the students' parents. After convenience sampling and giving adequate explanations about the project to the sampled people, self-administered questionnaires will be extracted from parents and then the theory of social skills training will be provided to students by the research team according to the instructions. Training is during 10 sessions, 90 minutes per week, which will be conducted inside the classroom with the presence of the entire students and principal teacher. The purpose of the training sessions is to increase their social skills in school and home environments and reduce their troublesome behaviors. The teacher is allowed to use the instructions during the week based on the training that will be observed (the accompaniment of the teacher is part of the package, not confounding but part of the intervening).
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Guilan University of Medical Sciences
Street address
Guilan University of Medical Sciences,Rasht, Namjoo Blvd
City
Rasht
Province
Guilan
Postal code
4193893345
Approval date
2018-01-29, 1396/11/09
Ethics committee reference number
IR.GUMS.REC.1396. 412
Health conditions studied
1
Description of health condition studied
Mental Health
ICD-10 code
Z04.6
ICD-10 code description
Encounter for general psychiatric examination, requested by authority
Primary outcomes
1
Description
Mental Health
Timepoint
The effectiveness of intervention will be assessed the first study and after the end of the school year based on the score obtained.
Method of measurement
from the Strengths and difficulties questionnaire (SDQ) for assessing mental health and Matson's assessment of social skills.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: For social skills training to students, the relevant teacher will be used that each week is in relation with them. The content of the social skills training protocol include the Teacher Guidebook and the Child Workbook. This package will be prepared to provide a comprehensive, simple, functional and appropriate with features of Iranian children of 6 to 12 years old. This protocol includes a step-by-step application guide with examples appropriate with age of child for the performer that can be a teacher or training adviser from diploma level to high degrees and includes 10 skills. 1- Self-efficacy 2- Empathy 3. Effective communication 4. Creative thinking 5. Critical thinking 6. Problem-solving 7. Management of emotions 8. Conflict with stress 9. Decision-making. 10. Dare skill and telling No. (Introduction of Social Skills Training Package is presented in the Appendix.)
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Baran Andisheh Elementary School
Full name of responsible person
Dr Maryam Kousha
Street address
Shahid Ansari Blvd, Baran Andisheh Elementary School, Rasht
City
Rasht
Province
Guilan
Postal code
419395599
Phone
+98 13 3366 6268
Email
maryamkousha@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Dr Mirsaeed Atarchi
Street address
Guilan University Of Medical Sciences, Namjo Blvd, Rasht
City
Rasht
Province
Guilan
Postal code
419395599
Phone
+98 13 3333 5820
Email
msattarchi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rasht 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
Rasht University of Medical Sciences
Full name of responsible person
Dr Maryam Kousha
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
15 khordad avenue, Shafa Hospital, Rasht, Iran
City
Rasht
Province
Guilan
Postal code
419395599
Phone
+98 13 3366 6268
Email
maryamkousha@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Dr Maryam Kousha
Position
Associate Professor, Psychiatry
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
15 khordad avenue, Shafa Hospital, Rasht, Iran
City
Rasht
Province
Guilan
Postal code
419395599
Phone
+98 13 3366 6268
Email
maryamkousha@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Dr Reihane Saber Ofoghi
Position
Rasht
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
15 khordad avenue, Shafa Hospital, Rasht, Iran
City
Rasht
Province
Guilan
Postal code
419395599
Phone
+98 13 3366 6268
Email
kavosh1400@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
Yes - There is a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The data will be specified and saved by assigning the code
When the data will become available and for how long
After the study and publication of its paper
To whom data/document is available
Researchers and academic people
Under which criteria data/document could be used
According to the ethics code of the researchers from the Department of Research and Technology of Guilan University of Medical Sciences, the documentation will be usable.
From where data/document is obtainable
DR Maryam Kousha, Guilan University Of Medical Sciences
What processes are involved for a request to access data/document
Examining the qualifications of the requesting person and having a code of ethics from a university center will be carried out