To determine whether preschool girls could learn personal safety skills when taught by their mothers.
Design
Participants included 56 preschool girls and their mothers. Eligible samples were chosen through systematic random sampling from two health centers, which served the largest and most diverse population in terms of cultural, economic, and social levels. The demographic databases were provided by the health system, and households with a preschool girl were identified (N = 336). To achieve the required sample size of 56, eligible mothers were chosen through systematic random sampling from the list using sampling distance (k), [k=N/n = 336/56 = 6]. From 1 to 6, the number 2 was chosen randomly as the first sample. The second sample was selected by adding the number 6 to the first mother and this process continued until the end.
First, the samples were identified. By using a randomized test, the intervention group was selected between the intervention and control groups. Then, the first name was randomly selected of the names of the mothers.
The first name was placed in the intervention group, and then the next names sequentially were placed in the control and intervention groups.
Settings and conduct
This study was performed in Golha Health Center in Gorgan city and blinding was not performed in this study.
Participants/Inclusion and exclusion criteria
Inclusion criterion: preschool girls
Intervention groups
Intervention group: receiving education by mothers.
Control group: receiving no intervention
Main outcome variables
Knowledge, skills
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190307042958N1
Registration date:2020-10-20, 1399/07/29
Registration timing:retrospective
Last update:2020-10-20, 1399/07/29
Update count:0
Registration date
2020-10-20, 1399/07/29
Registrant information
Name
somayeh Gholam farkhani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4721 2046
Email address
somayeh.farkhani@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-06-19, 1395/03/30
Expected recruitment end date
2016-10-21, 1395/07/30
Actual recruitment start date
2016-06-18, 1395/03/29
Actual recruitment end date
2016-10-20, 1395/07/29
Trial completion date
2016-10-20, 1395/07/29
Scientific title
The effect of personal safety education to mothers on the knowledge and skills on sexual abuse prevention of preschool girls
Public title
The effect of personal safety education to mothers on the knowledge and skills about sexual abuse prevention
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Preschool girls
Exclusion criteria:
Age
From 5 years old to 6 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
56
Actual sample size reached:
52
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible samples were chosen through systematic random sampling from two health centers, which served the largest and most diverse population in terms of cultural, economic, and social levels. The demographic databases were provided by the health system, and households with a preschool girl were identified (N = 336). To achieve the required sample size of 56, eligible mothers were chosen through systematic random sampling from the list using sampling distance (k), [k=N/n = 336/56 = 6]. From 1 to 6, the number 2 was chosen randomly as the first sample. The second sample was selected by adding the number 6 to the first mother and this process continued until the end. First, the samples were identified. By using a randomized test, the intervention group was selected between the intervention and control groups. Then, the first name was randomly selected of the names of the mothers. The first name was placed in the intervention group, and then the next names sequentially were placed in the control and intervention groups.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Golestan University of Medical Sciences
Street address
Fourth kilometer of Gorgan road
City
Gorgan
Province
Golestan
Postal code
934174515
Approval date
2016-05-03, 1395/02/14
Ethics committee reference number
941218332
Health conditions studied
1
Description of health condition studied
Preventing child Sexual Abuse
ICD-10 code
T76.22XS
ICD-10 code description
Child sexual abuse, suspected, sequela
Primary outcomes
1
Description
Knowledge
Timepoint
Pretest, post test (one week), follow-up test (one month)
Method of measurement
questionnaire
2
Description
Skill
Timepoint
Pretest, post test (one week), follow-up test (one month)
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group (Education by mother): After receiving informed and written consent from the parents. At the beginning of each interview, the concept of "private parts" of the body was taught to the children. After completing interviews with PSQ-P and WIST-P (Time 1), the mothers of the education group were invited to attend mothers' training classes offered the following two days. The personal safety training session was held by the researcher for the mothers of the education group (in 4 groups of 4-8 people for 90-120 minutes), which focused on the importance of preventing CSA and the training needed to protect children's personal safety as well as how to educate their children at home using the Persian version of Body Safety Training workbook (BST; Wurtele, 2007). At the end of the class, each mother was given a copy of the Body Safety Training workbook to teach her daughter over the week. We asked the mothers in the educational group to teach their children at least one lesson a day. During one week of at-home training, the researcher contacted the mothers twice (days 2 and 5) to track the progress of educating their children and answer their questions, if any. Two days after the completion of the one week training by mothers to children, children were interviewed using the PSQ-P and WIST-P (Time 2). Follow-up testing (Time 3) was conducted for children one month after the post-test.
Category
N/A
2
Description
Control group: After receiving informed and written consent from the parents or legal guardians of the children. At the beginning of each interview, the concept of "private parts" of the body was taught to the children. After completing interviews with PSQ-P and WIST-P (time1). Mothers of the control group were thanked for their presence and cooperation, and were asked to revisit 11 days later for the post-test of the children.children in control groups were interviewed using the PSQ-P and WIST-P (Time 2). Follow-up testing (Time 3) was conducted for children in control group one month after the post-test. interested mothers of the control group were given a copy of the BST workbook.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Golha Health Center
Full name of responsible person
Elham Khoori, Somayeh Gholamfarkhani
Street address
At the end of Golbarg 1; Golha street
City
Gorgan
Province
Golestan
Postal code
017-32151811
Phone
+98 17 3215 1811
Email
somayeh.farkhani@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Elham Khoori
Street address
At the beginning of Shastkolah road
City
Gorgan
Province
Golestan
Postal code
74515-49341
Phone
+98 74 5154 9341
Email
somayeh.farkhani@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gorgan 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
Mashhad University of Medical Sciences
Full name of responsible person
Somayeh Gholam Farkhani
Position
Associate professor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Department of Obstetrics and Gynecology, Shohada Hospital
City
Quchan
Province
Razavi Khorasan
Postal code
49341-74515
Phone
+98 51 4725 8085
Email
somayeh.farkhani@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Elham Khoori
Position
Associate professo
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
The top of the sixty hat road
City
gorgan
Province
Golestan
Postal code
74515-49341
Phone
+98 17 3245 7085
Email
elikami20@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Somayeh Gholam Farkhani
Position
midwife
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Department of Obstetrics and Gynecology, Shohada Hospital
City
Quchan
Province
Razavi Khorasan
Postal code
74515-49341
Phone
+98 51 4725 8085
Email
somayeh.farkhani@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
Yes - There is a plan to make this available
Title and more details about the data/document
By anonymizing the participants in this study , all the research results can be shared.
When the data will become available and for how long
2019
To whom data/document is available
Public
Under which criteria data/document could be used
Researcher
From where data/document is obtainable
Golestan University of Medical Sciences
What processes are involved for a request to access data/document
Send an e-mail request to the Dr.Elham Khoury , somayeh gholam farkhani