The determination of effectiveness of self-care educations on knowledge and protective behaviors of children
Design
Randomized clinical trial with two control and intervention group.35 children are chosen as intervention group .35 children are chosen as control group . Systematic randomized sampling method .One blinded study.
Settings and conduct
This study is a randomized clinical trial that will be done in the kindergartens of welfare organization of Tehran.Samples are 70 children between the age of 5-6 that are allocated into two control and intervention group by randomization. Four educational sessions are represented to intervention group.One educational session is represented to control group.Post test is done one month after the intervention.The study is one-blinded and samples aren't informed of allocation into control and intervention group.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Children between the age of 5-6.
Children with no physical or mental disability.
Children who haven't participated in child sexual abuse educational programms in the past.
Exclusion criteria:
Children whose parents didn't consent to their participation in the study
Physical or mental disability during the study
Intervention groups
Intervention group :35 children between the age of 5-6 are chosen as intervention group .Four educational sessions about child sexual abuse are represented to them .
Children will learn that some places and things are private ، also they will learn about privacy، different kinds of touches and requests. Saying firm "no"is taught. they will learn how to react in the situation of abuse .
Control group::35 children between the age of 5-6 are chosen as control group. One educational session about safety of accidents is represented to them .
Main outcome variables
Knowledge of children
protective behaviors of children
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190713044192N1
Registration date:2019-11-03, 1398/08/12
Registration timing:registered_while_recruiting
Last update:2019-11-03, 1398/08/12
Update count:0
Registration date
2019-11-03, 1398/08/12
Registrant information
Name
Zohreh Maleki
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 3348 4604
Email address
iris_decor_group@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-23, 1398/06/01
Expected recruitment end date
2019-11-21, 1398/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of the Self-Care Educations on Knowledge and Protective Behaviors of 5-6 Aged Children of Kindergartens of Tehran Welfare Organization
Public title
The Effect of the Self-Care Educations on Knowledge and Protective Behaviors of Children
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Children between the age of 5-6 .
Children with no physical or mental disability.
Children who haven't participated in child sexual abuse prevention educational programs in the past
Exclusion criteria:
Children whose parents didn't consent to their participation in the study
Physical or mental disability during the study
Age
From 5 years old to 6 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling method is cluster sampling.Tehran is divided in to 5 clusters ( north، south، east، west and the center).One kindergarten is chosen as intervention group and one kindergarten is considered as control group.In each kinder garten ، samples are chosen by systematic randomization .For this randomization، one number is chosen from 1-10.the population of each kindergarten is divided to the considered sample size to determine the samples interval.the determined interval is added to the randomized beginner number till the sampling is done.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this research، one kindergarten is chosen as intervention group and another one is chosen as control group in each cluster، so samples aren't informed of allocation.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Science
Street address
Ghods street، Enghelab square
City
Tehran
Province
Tehran
Postal code
3439123900
Approval date
2019-05-19, 1398/02/29
Ethics committee reference number
IR.TUMS.FNM.REC.1398.021
Health conditions studied
1
Description of health condition studied
Knowledge and protective behavior of children
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The earned score of children's knowledge about child sexual abuse based on PSQ(personal safety questionaire).
Timepoint
Evaluation of children's knowledge before the intervention via pre-test and evaluation of children's knowledge one month after the intervention via post-test
Method of measurement
PSQ(personal safety questionaire) for evaluation of knowledge level
2
Description
The earned score of children's protective behavior based on WIST(what if situation test)
Timepoint
Evaluation of children's protective behavior before the intervention via pre-test and evaluation of children's protective behavior one month after the intervention via post-test
Method of measurement
WIST( what if situation test) questionnaire for evaluation of protective behavior of children
Secondary outcomes
empty
Intervention groups
1
Description
4 educational sessions about child sexual abuse prevention are represented to intervention group . Children will learn about privacy and private things، different types of touches and requests.They will acquire the skill of saying firm "no"، also will learn how to react in the situation of abuse and how to protect themselves.
Category
Prevention
2
Description
Control group: One educational session about safety of accident is represented to control group.Children learn how to protect themselves in the situation of flood and earthquake.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Kindergartens of Tehran
Full name of responsible person
Tehran state welfare organization
Street address
Zafar street-Valiasr street
City
Tehran
Province
Tehran
Postal code
1968713111
Phone
+98 21 8887 9594
Email
child@behzisti.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammadali Sahraeian
Street address
Ghods street-Enghelab square
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 81631
Email
tums_edu@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Farnaz Farnam
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Tohid square-Facaulty of nursing and midwifery
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 4411
Email
f_farnam@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zohre Maleki
Position
Midwife
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Tohid square-Facaulty of Midwifery and Nursing
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4217
Email
Z_maleki63@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zohre Maleki
Position
Midwife
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Tohid square-Facaulty of Midwifery and Nursing
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4217
Email
z_maleki63@yahoo.com
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
Participant's informations are secret.
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
One copy of thesis is kept in library of Faculty of midwifery and nursing of TUMS
When the data will become available and for how long
No limited timespan
To whom data/document is available
All the collegians of Faculty of midwifery and nursing of TUMS
Under which criteria data/document could be used
-
From where data/document is obtainable
Faculty of midwifery and nursing of TUMS
What processes are involved for a request to access data/document