The effect of child sexual abuse prevention program on student’s awareness & protective skills
Design
A randomized clinical trial with 2 parallel intervention groups without blinding
Settings and conduct
Mallard town is divided into 2 socio-economic parts. A girls' and a boys' primary school will be selected randomly (overall 4 schools). In each school, two classes in third grade will be selected randomly. Students in one class will be trained by the teacher and in the other class by their parents.
Participants/Inclusion and exclusion criteria
Students inclusion criteria:
Age 9-10 years
Third grade elementary
Student's consent
Parents or guardian's consent
Mental health and normal intelligence
Teachers and parent's Inclusion criteria :
Teachers and parent's consent
Not attending classes about child sexual abuse prevention in the last 6 months.
The physical and mental ability for attendance in class
Intervention groups
The 1st group: Students training by teachers. The 2nd group: Students training by parents. َAt the first, simultaneously educational classes will be conducted for teachers and parents, in four 50 minutes weekly sessions by the researcher's team. Then these teachers or parents train children's on a standard and uniform format, which will be four 20 minutes weekly sessions. Both parents and teachers will be followed up weekly to follow the protocol and teaching methods during this period.
Main outcome variables
Primary outcomes (Assess before and again 2 months after training):
1. Child Sexual abuse Awareness (asses by Personal Safety Questionnaire).
2. Child Sexual abuse skills (protective skills) (asses by What If Situation Test).
3. Sexual abuse self-disclosure (asses by 3 questions).
4. Child's fear (asses by Fear Assessment Thermometer scale).
Secondary outcomes:
1. Parents' and teacher's awareness and attitude (asses CSA Myth Scale).
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120609009975N10
Registration date:2021-09-09, 1400/06/18
Registration timing:prospective
Last update:2021-09-09, 1400/06/18
Update count:0
Registration date
2021-09-09, 1400/06/18
Registrant information
Name
Farnaz Farnam
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6105 4217
Email address
fz.farnam@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-30, 1400/08/08
Expected recruitment end date
2022-02-05, 1400/11/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect Of Child Sexual Abuse Prevention Program On Student’s Awareness And Protective Skills: A Comparison Of Teachers And Parents As Instructors
Public title
The Effect Of Child Sexual Abuse Prevention Program On Student’s Awareness And Protective Skills: A Comparison Of Teachers And Parents As Instructors
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria for students:
1) Age 9-10 years
2) Third grade elementary
3) Student's consent
4) Parents or guardian's consent
5) Mental health and normal intelligence
Teachers and parents Inclusion criteria :
1)Teachers and parent's consent
2) Not attending training classes about child sexual abuse prevention in 6 month ago
3) Physical and mental ability for attendance in class
Exclusion criteria:
Age
From 9 years old to 10 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
160
Randomization (investigator's opinion)
Randomized
Randomization description
In order to do this research, a small town named Mallard, divided into two parts based on the economic and social level. All primary schools are listed, and then from each part, a governmental girls' primary school and a boys' primary school will be selected by simple randomization by random lottery (overall four primary schools). These four schools will consider as the cluster. From the list of the third-grade classes in each school, one class is set as intervention group 1 and one class at intervention class 2 randomly. So the students in one class will be trained by the teacher and the other class by their parents.
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
School of Nursing and Midwifery & Rehabilitation - Tehran University of Medical Science
Street address
Tohid square, Dr.Mirkhani street, school of Nursing and Midwifery
Child Sexual abuse Awareness: Children's knowledge about definitions and prevention of child sexual abuse prevention.
Timepoint
At the beginning of the study (before the intervention) and two months after the intervention
Method of measurement
Child Sexual abuse Awareness:: Assessment will be with the "Questionnaire Personal Safety". This questionnaire includes 12 questions to assess children's awareness of sexual abuse. Each question has three options "Yes", "No", "I do not know". Each correct answer will be given a score and the wrong answer and I do not know will not be given a score. Scores range from 0-12 and the highest scores indicate the highest level of students' awareness.
2
Description
Child Sexual abuse skills (self-protective skills): It refers to children's practical skills in protecting themselves from sexual abuse.
Timepoint
At the beginning of the study (before the intervention) and two months after the intervention
Method of measurement
Child Sexual abuse skills (self-protective skills): It will be evaluated by What If Situation Test questionnaire
3
Description
Sexual abuse self-disclosure: Self-disclosure refers to cases of sexual abuse that occurred to the child.
Timepoint
At the beginning of the study (before the intervention) and two months after the intervention
Method of measurement
This outcome is measured by three standard questions and students answer these questions to the researcher in the pre-test and post-test.
4
Description
Child's Fear: The meaning of fear in this study is the general fear of students about objects, people and situations under the influence of self-protection educational programs.
Timepoint
At the beginning of the study (before the intervention) and two months after the intervention
Method of measurement
Child's Fear: The Fear Assessment Thermometer scale questionnaire measures the level of fear or potential harm of education that measures the level of fear created in the child after these trainings. This questionnaire includes 12 related and unrelated items such as fear of insects, strangers, going to bed, being alone in the dark, going to the doctor, etc.
Secondary outcomes
1
Description
Teachers and parent's sexual awareness : refers to the awareness of teachers and parents regarding the prevention of sexual abuse of children.
Timepoint
Before and after training teachers and parents
Method of measurement
The CSA Myth Scale questionnaire will be used to assess teachers 'and parents' sexual awareness of child sexual abuse. This questionnaire contains 15 5-item items, from "Strongly Agree" to "Strongly Disagree".
2
Description
teachers and parent's sexual attitudes : refers to the attitudes of teachers and parents regarding the prevention of child sexual abuse.
Timepoint
Before and after training teachers and parents
Method of measurement
The CSA Myth Scale questionnaire will be used to assess teachers 'and parents' sexual attitudes toward child sexual abuse. This questionnaire contains 15 5-item items, from "Strongly Agree" to "Strongly Disagree".
Intervention groups
1
Description
Intervention group 1: Students who will receive training from their teachers will be in the first intervention group. To unify the education, the researcher will provide the necessary training about child sexual abuse to teachers and parents simultaneously, in the form of 4 weekly training sessions of 50 minutes. In the first session, the content includes the definition, types, prevalence, complications, risk factors, possible physical, psychological and social symptoms of the child victim, evidence on the impact of education on prevention, barriers for parents and teachers to talk to children, potential benefits and harms. It will be about CSA. In the second session, the concepts of body ownership, private parts of the body, the concept of privacy, defining the trust circle, and how to report suspicious cases will be taught. The content of the third session will include recognizing good and bad touches, distinguishing between right and wrong, the four skills of saying no, leaving the place, the need to report, specifying the list of trusted people to report, and how to report. The content of the fourth session includes ensuring part of the child's innocence, building trust in the student to express their feelings, ensuring part of the attention and acceptance of adults if reporting, proposing hypothetical scenarios, and practicing skills to facilitate teaching students by teachers. And will be parents. In each session, appropriate educational methods for the topics are also provided. After familiarizing teachers and parents with the necessary content and skills, different educational methods, and tailored to the age group of children to teach prevention of sexual abuse, parents and teachers will be taught. These methods are storytelling, drama games, role-playing, video cards, animation, etc. If possible, classes will be held in person, but due to the corona pandemic conditions, training will be provided virtually if not allowed. Virtual education is done online in the environment that was used during the school pandemic, and in case of not using a special environment, Skyroom or Skype is used. At the end of the fourth session, teachers and parents will be retested. Both groups are then asked to share educational content with the children. Education for children is also in a standard and uniform format, which will be in 4 sessions of 20 minutes at a distance of one week, and during this period, both parents and teachers will be followed up weekly to teach them according to the protocol and teaching methods. Cooked to be done. 2 months after the end of the training session for parents and teachers, children will be tested. How to do pre-tests and post-tests will be in person unless the conditions do not allow this access, in which case it will be an online questionnaire for parents and teachers, which can be sent via email or WhatsApp, or other communication tools in cyberspace. At the discretion of the participants.
Category
Prevention
2
Description
Intervention group 2: Students who will receive the same training from their parents will be in the second intervention group.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Mallard County Department of Education
Full name of responsible person
Zahra Samaee
Street address
Malard Road
City
Malard
Province
Tehran
Postal code
3169159588
Phone
+98 21 6105 4000
Email
z.samaei75@gmail.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Sahraian
Street address
Keshavarz Boulevard. Central building of Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
.1419733181
Phone
+98 21 4291 1405
Email
tumspr@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
70
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
Zahra Samaee
Position
M.Sc.
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Towhid Street
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4000
Email
z.samaei75@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Farnaz Farnam
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Towhid Street
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4217
Email
f_farnam@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zahra Samaei
Position
M.Sc.
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Towhid Ave
City
Tehran
Province
Tehran
Postal code
3169988157
Phone
+98 21 6517 1654
Email
z.samaei75@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
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
Yes - There is a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
.
When the data will become available and for how long
.
To whom data/document is available
.
Under which criteria data/document could be used
.
From where data/document is obtainable
.
What processes are involved for a request to access data/document