Protocol summary

Study aim
The purpose of this study is to improve self-care behavior, reduce the possibility of sexual abuse, and subsequently reduce the harmful consequences of this for them. As a result of the positive effects of this study, this educational method is used to protect children and raise a healthy generation. And a healthy and, consequently, a strong and developed society in the future, he proposed welfare organizations and related centers.
Design
A semi-experimental intervention with two control and intervention groups, convenience sampling, 30 samples in each control and intervention group
Settings and conduct
Child laborer's schools (Molavi and Khavaran centers), pre-testing and then training for the intervention group in 4 one-hour sessions, post-testing immediately and 3 months after the intervention (during the three months after the intervention, conducting ten reminder sessions)
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1-children between the ages of 7 and 12, 2-referees to the Molavi and Khavaran child laborer protection centers, 3-not suffering from incurable or untreated neurological, mental disorders, or mental retardation. Exclusion criteria: 1- Unwillingness to participate or continue attending the study 2- Not attending two or more training sessions 3- Not filling out more than 20% of the questionnaire
Intervention groups
Intervention group: educating 9 steps to prevent sexual abuse such as 1- introducing private parts of the body to children according to the age of the child (your body belongs to you) 2- recognizing good contact and bad contact Control group: will be subjected to pre-test and post-test only, and after the completion of the project, they will be trained in 9 steps designed for the intervention group.
Main outcome variables
Empowerment of child laborers for self-care against sexual abuse

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220410054484N1
Registration date: 2023-10-09, 1402/07/17
Registration timing: prospective

Last update: 2023-10-09, 1402/07/17
Update count: 0
Registration date
2023-10-09, 1402/07/17
Registrant information
Name
niloofar najafali dizaji
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3384 4864
Email address
najafali.n@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-22, 1402/07/30
Expected recruitment end date
2024-03-20, 1403/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the Effect of Empowerment on Self-Care of Child Laborers in the Prevention of Sexual Abuse
Public title
Preventing Sexual Abuse among Child Laborers
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Children between the ages of 7 and 12 Referees to the Molavi and Khavaran child laborer protection centers Not suffering from incurable or untreated neurological and mental disorders or mental retardation
Exclusion criteria:
Unwillingness to participate or continue attending the study Not attending two or more training sessions Not filling more than 20% of the questionnaires
Age
From 7 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
In this study, educational methods such as: group discussion, role playing and positive behavioral reinforcement to increase the effectiveness and durability of information in the minds of child laborers in the field of 9 important axes of self-care against sexual abuse will be used.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Joint Organizational Ethics Committee of the School of Nursing, Midwifery and Rehabilitation
Street address
Dr Mikhani Street, Tohid Square
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2020-09-30, 1399/07/09
Ethics committee reference number
IR.TUMS.FNM.REC.1399.102

Health conditions studied

1

Description of health condition studied
Sexual Abuse
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Empowerment of Child Laborers for Self- Care Against Sexual Abuse
Timepoint
1-At the beginning of the intervention, 2- Immediately after the end of the intervention, and 3- 3 months after the end of the intervention
Method of measurement
1- Demographic questionnaire, 2- Children's knowledge of abuse questionnaire- revised, 3- What if situation test(CWIST), 4- Child sexual abuse attitude scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Educating 9 steps to prevent sexual abuse: 1- Introducing private parts of the body to children according to their age (your body belongs to you) 2- Recognizing good contact and bad contact 3- Recognizing good secrets from bad secrets 4- Recognizing the abuser and that the abuser is not just a strange 5. Ways the abuser will try to trick the child into accompanying him or her to another place (Never go anywhere with an unknown person, even if he or she offers you a reward 6- Saying no and resisting inappropriate behaviors and requests and escaping from dangerous situation 7- Exposing abuse 8. Who can the child share this matter with, and ask for help 9- Do not blame yourself for sexual harassment
Category
N/A

2

Description
Control group: They will be educated after finishing the intervention.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Khavaran Child Laborer Center
Full name of responsible person
Niloofar Najafali Dizaji
Street address
Department of Child laborer. District 15, Department of Soacial-welfare affairs, Azam Nizami Alley, Khavaran Street, Khorasan Square
City
Tehran
Province
Tehran
Postal code
5716136874
Phone
+98 21 3343 2739
Email
niloo.7430@gmail.com

2

Recruitment center
Name of recruitment center
Molavi Child Laborer Center
Full name of responsible person
Niloofar Najafali Dizaji
Street address
No.7, Saba's School Alley, Shahid Mehdi Hosseini Alley, Bor Bor Street, Shahrdari Street, Mostafa Khomeini Ave
City
Tehran
Province
Tehran
Postal code
3176148574
Phone
+98 21 5557 6687
Email
niloo.7430@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Akbar Fotuhi
Street address
Tehran University of Medical Sciences Headquarters, Qods corner, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1461884513
Phone
+98 21 81631
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
60
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
Niloofar Najafali Dizaji
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Urmia University of Medical Sciences, 11 km of Sero Road
City
Urmia
Province
West Azarbaijan
Postal code
5756115335
Phone
+98 44 3275 4961
Email
najafali.n@umsu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Jamalodin Begjani
Position
associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
District 6, East Nusrat Street
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4424
Email
jamalbegjani@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Niloofar Najafali Dizaji
Position
instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Urmia University of Medical Sciences, 11 km of Sero Road
City
urmia
Province
West Azarbaijan
Postal code
5756115335
Phone
+98 939 023 7430
Email
niloo.7430@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
Submitted and will be published
When the data will become available and for how long
Through the corresponding author's email and correspondence with the responsible author, the information will be provided to the authors who declare a need after the study is completed.
To whom data/document is available
Through the corresponding author's email and correspondence with the responsible author, the information will be provided to the authors who declare a need after the study is completed.
Under which criteria data/document could be used
Through the corresponding author's email and correspondence with the responsible author, the information will be provided to the authors who declare a need after the study is completed.
From where data/document is obtainable
Through the corresponding author's email and correspondence with the responsible author, the information will be provided to the authors who declare a need after the study is completed.
What processes are involved for a request to access data/document
Through the corresponding author's email and correspondence with the responsible author, the information will be provided to the authors who declare a need after the study is completed.
Comments
Through the corresponding author's email and correspondence with the responsible author, the information will be provided to the authors who declare a need after the study is completed.
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