Protocol summary

Study aim
The Effectiveness of Empathy Training on Aggression, Adaptation and Social Responsibility of Preschool Children
Design
This study has a control group and random selection. The study was conducted without blinding. The intervention was conducted on 42 subjects in two groups of 21 subject. Excel software function was used for randomization.
Settings and conduct
To conduct the research, firstly, two centers were selected from the preschool centers of the 1st district of Hamedan city, and after coordinating with the officials of these centers, a sample of 50 children was selected. Then the children were informed about the time and schedule of educational sessions. After selecting the sample, people were randomly assigned to two control and experimental groups, and training sessions were held for the experimental group. It should be noted that the people in the experimental group participated in 8 sessions training , which were held twice a week, and the training period lasted for one month.
Participants/Inclusion and exclusion criteria
Inclusion criteria: informed consent of the child and parents. Exclusion criteria: presence of psychological disorder and use of any psychological intervention or psychiatric medication.
Intervention groups
The experimental group received the empathy intervention. In order to teach empathy to children, the Empathy educational program (Jan Bozorgi et al., 2013) was used, which is suitable for preschool and elementary school children. The control group did not receive any special intervention and remained in the waiting list.
Main outcome variables
Aggression, Adaptation, Social Responsibility

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20231022059801N1
Registration date: 2023-12-14, 1402/09/23
Registration timing: retrospective

Last update: 2023-12-14, 1402/09/23
Update count: 0
Registration date
2023-12-14, 1402/09/23
Registrant information
Name
Abolghasem Yaghoobi
Name of organization / entity
Bu-Ali Sina University
Country
Iran (Islamic Republic of)
Phone
+98 81 3140 1804
Email address
yaghoobi@basu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-09, 1402/01/20
Expected recruitment end date
2023-04-19, 1402/01/30
Actual recruitment start date
2023-09-01, 1402/06/10
Actual recruitment end date
2023-09-06, 1402/06/15
Trial completion date
2023-10-12, 1402/07/20
Scientific title
The Effectiveness of Empathy Training on Aggression, Adaptation and Social Responsibility of Preschool Children
Public title
The Effectiveness of Empathy Training on Aggression, Adaptation and Social Responsibility of Preschool Children
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Minimum age is 5 years old Maximum age is 6 years old
Exclusion criteria:
Having psychological disorders
Age
From 5 years old to 6 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 50
Actual sample size reached: 42
Randomization (investigator's opinion)
Randomized
Randomization description
After selecting the sample using the table of random numbers, the subjects were randomly replaced in the experimental and control groups.A table of random numbers is a collection of numbers that are generated completely randomly without a specific pattern or order and are presented as a table. In order to use the table of random numbers, the researcher must first determine the direction of reading the numbers in the table (for example, up, down, left or right, in this study left to right was chosen). The second assumption of the researcher is to consider numbers for different groups (even numbers were considered for the intervention group and odd numbers were considered for the control group). Then the researcher randomly selected one of the numbers and moved in one of the predetermined directions (from left to right in this study) and recorded the numbers and allocated them to the intervention and control groups, and this process continued until all the sample subject were selected.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Bu-Ali Sina University
Street address
Chaharbagh Shahid Mostafa Ahmadi Roshan, Bu-Ali Sina University, Hamedan
City
Hamedan
Province
Hamadan
Postal code
۶۵۱۷۸-۳۸۶۹۵
Approval date
2023-07-10, 1402/04/19
Ethics committee reference number
IR.BASU.REC.1402.046

Health conditions studied

1

Description of health condition studied
Aggression
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Aggression
Timepoint
Pre-test stage and post-test stage - one month interval
Method of measurement
Measure: Questionnaire

2

Description
Adaptation
Timepoint
Pre-test stage and post-test stage - one month interval
Method of measurement
Measure: Questionnaire

3

Description
Social Responsibility
Timepoint
Pre-test stage and post-test stage - one month interval
Method of measurement
Measure: Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: intervention group (empathy training): To teach children empathy, empathy training programs (Jan Bozorgi, Noori and Agah Haris, 2014), which are suitable for preschool and elementary children. The program consists of four steps as follows: Step One: Introduction to physiological feelings such as hunger, thirst, fatigue, cold, heat. Step Two: Introduction to psychological feelings such as sadness, anger, happiness. Step Three: Focusing on the similarity and difference of your feeling with another and emphasizing your feelings. Step Four: Strengthening empathy responses. The intervention program was conducted by the researcher in the pre -school training classes. The intervention took place in eight sessions one hour.
Category
Behavior

2

Description
Control group: The control group did not receive any intervention in the present study and received the usual daily training during the intervention period in experimental group.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Hedayat preschool center
Full name of responsible person
Dr. Rasool Kordnoghabi
Street address
No, 34, Besat Blvd., Hamedan
City
Hamedan
Province
Hamadan
Postal code
6517589652
Phone
+98 81 4423 5474
Email
rkordnoghabi@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Bu Alisina University
Full name of responsible person
Dr Arash Ghorbani
Street address
Hamedan, Chaharbagh Shahid Mostafa Ahmadi Roshan, Bu Ali Sina University
City
Hamedan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۶۹۵
Phone
+98 81 3140 0000
Email
a.ghorbani@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bu Alisina University
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
Bu-Ali Sina University
Full name of responsible person
Abolghasem Yaghoobi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Hamedan, Chaharbagh Shahid Mostafa Ahmadi Roshan, Boali Sina University
City
Hamedan
Province
Hamadan
Postal code
۳۸۶۹۵-۶۵۱۷۸
Phone
+98 81 3284 5541
Email
Yaghoobi@basu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bu-Ali Sina University
Full name of responsible person
Abolghasem Yaghoobi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Hamedan, Chaharbagh Shahid Mostafa Ahmadi Roshan, Boali Sina University
City
Hamedan
Province
Hamadan
Postal code
۳۸۶۹۵-۶۵۱۷۸
Phone
0098 81 3284541
Email
Yaghoobi@basu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Bu-Ali Sina University
Full name of responsible person
Abolghasem Yaghoobi
Position
Professo
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Hamedan, Chaharbagh Shahid Mostafa Ahmadi Roshan, Boali Sina University
City
Hamedan
Province
Hamadan
Postal code
۳۸۶۹۵-۶۵۱۷۸
Phone
0098 81 3284541
Email
Yaghoobi@basu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
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