Protocol summary

Study aim
determining the effect of personal safety education to mothers on the knowledge and skills for the prevention sexual abuse of preschool-aged boys, in Gorgan,2018.
Design
Randomized, randomized,Parallel group trial with pretest-posttest design with two groups of intervention and control
Settings and conduct
Referring to 2 health centers 4 and 3 in Gorgan, the total number of mothers with pre-school boys eligible to enter each center is determined. Then, in each center, a random selection of k or sampling intervals is used. After contact with them and willingness to participate in the research, they are invited. For all samples (boys), the status quo test questionnaires are "if and" and the individual safety questionnaire is completed and then divided randomly into two groups of intervention and control. For mothers of the intervention group, a personal safety training program is being implemented to transfer to their sons, after completing the intervention, all questionnaires will be completed again.
Participants/Inclusion and exclusion criteria
Inclusion criteria 1. Iranian and resident of Gorgan .2. Minimum education level (Mother). The absence of mental and physical illnesses in the mother and the child 3. Lack of sexual abuse in the child .4. Child life with both biological parents. exclusion criteria 1. Unwillingness to cooperate 2. Migration from Gorgan
Intervention groups
Personal safety education
Main outcome variables
Increase general knowledge and skills in the intervention group in examining three stages of time

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20181130041798N1
Registration date: 2019-03-14, 1397/12/23
Registration timing: retrospective

Last update: 2019-03-14, 1397/12/23
Update count: 0
Registration date
2019-03-14, 1397/12/23
Registrant information
Name
azam hokmabadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3245 6900
Email address
azam.hokmabady@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-22, 1397/07/30
Expected recruitment end date
2019-01-19, 1397/10/29
Actual recruitment start date
2018-10-22, 1397/07/30
Actual recruitment end date
2019-01-20, 1397/10/30
Trial completion date
empty
Scientific title
The effect of personal safety education to mothers on the knowledge and skills for the prevention sexual abuse of preschool-aged boys.
Public title
"The effect of personal safety education to mothers on the knowledge and skills for the prevention sexual abuse of preschool-aged boys"
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Mothers with their preschool boys (6-7 years old)
Exclusion criteria:
Entry criterion (mother)1. Invited to participate in the study. Iranian and resident of Gorgan. 3. At least the education required to complete the course. 4. Chronic mental illness and physical illnesses (self-expression). 5. Decides not to migrate from Gorgan to the end of the project. The entry level (child) 1. The child has the ability to understand the verbal question and answer.2. Chronic mental illness and physical illnesses (remarks by the mother). 3. The child has not been sexually abused (remarks by the mother) .4 The child lives with both his biological parents.
Age
From 6 years old to 7 years old
Gender
Male
Phase
N/A
Groups that have been masked
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 46
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization
Blinding (investigator's opinion)
Single blinded
Blinding description
Researcher
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Gorgan University of Medical Sciences
Street address
Gorgan - Kilometers 5 Gorgan Road to Sari - 1st Road of Shast Kola - Higher Education Complex in Golestan University of Medical Sciences
City
gorgan
Province
Golestan
Postal code
4913885778
Approval date
2018-09-16, 1397/06/25
Ethics committee reference number
1397.152

Health conditions studied

1

Description of health condition studied
Prevention of sexual abuse; Prevention of sexual abuse
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Mean score of knowledge to prevent sexual abuse
Timepoint
Two days and one month after the intervention
Method of measurement
personal safety questionair

Secondary outcomes

1

Description
mean Score of total Skills Prevention child abuse
Timepoint
Two days and one month after the intervention
Method of measurement
Questionnaire "What if Situation Test "

Intervention groups

1

Description
Intervention group: A personal safety training program is provided to mothers of pre-school boys during a training session and they are taken to their children within a week at home.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Health Center No. 3 and 4
Full name of responsible person
azam hokmabadi
Street address
The flowers, the end of the petal (center numbe; the castle of Hasan health center number 3
City
gorgan
Province
Golestan
Postal code
4913885778
Phone
+98 17 3243 0353
Email
azam.hokmabady@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
معاون تحقیقات و فناوری دانشگاه علوم پزشکی گرگان
Street address
Gorgan - Kilometers 5 Gorgan Road to Sari - First Road of the Sixty Kola - Higher Education Collegiate of Golestan University of Medical Sciences Vice-Chancellor for Research and Technology
City
gorgan
Province
Golestan
Postal code
4913885778
Phone
+98 17 3243 0353
Email
azam.hokmabady@gmail.comnh
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
Gorgan University of Medical Sciences
Full name of responsible person
Azam HekamAbadi
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Simetari Resalat, Resalat 35, Boye 1, Samen Complex
City
gorgan
Province
Golestan
Postal code
4913885778
Phone
+98 17 3268 4517
Email
azam.hokmabady@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
elham khoory
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Gorgan - Kilometers 5 Gorgan Road to Sari - 1st Road of Shast Kola - Higher Education Complex in Golestan University of Medical Sciences
City
gorgan
Province
Golestan
Postal code
4913885778
Phone
+98 17 3243 0353
Email
elhamkhoory@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
azam hokmabadi
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Simetari Resalat, Resalat 35, Boyu 1, Samen Complex
City
gorgan
Province
Golestan
Postal code
4913885778
Phone
+98 17 3268 4517
Email
azam.hokmabady@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Main outcome information
When the data will become available and for how long
Get started 6 months after printing results
To whom data/document is available
Researchers at universities
Under which criteria data/document could be used
No data analysis is allowed; For other research; by email
From where data/document is obtainable
research
What processes are involved for a request to access data/document
It takes about 15 to 30 days via email or phone call.
Comments
Loading...