Protocol summary

Study aim
Determining the effect of an educational program based on health belief model on protecting oneself against sexual harassment in children of vulnerable families
Design
A clinical trial with an intervention and control group, one-sided, randomized, will be selected for randomization based on a lottery of four centers and the research units will be selected by tapping a card or letter.
Settings and conduct
The research is done in child support centers in Isfahan. Sampling of children will be done by the researcher, but in order to complete the study, the questionnaire will be done by another person. (Key) and attractiveness that this method can be used in various ways to prevent sexual harassment
Participants/Inclusion and exclusion criteria
Children aged 8-11 years, research units residing in Isfahan, research units should not participate in any simultaneous counseling or psychotherapy program, no obvious symptoms of psychosis in children and mothers, no chronic illness or other mental disorders in Research units
Intervention groups
Educating children to protect themselves from sexual harassment will be used by showing movies, theater, role-playing, etc., and the control group will be provided with an educational package after completing the research.
Main outcome variables
Protecting yourself (awareness and skills) against sexual abuse in children

General information

Reason for update
Acronym
CSA
IRCT registration information
IRCT registration number: IRCT20210130050180N1
Registration date: 2021-10-02, 1400/07/10
Registration timing: registered_while_recruiting

Last update: 2021-10-02, 1400/07/10
Update count: 0
Registration date
2021-10-02, 1400/07/10
Registrant information
Name
Zahra Shafizadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3663 5234
Email address
shzahra95@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-23, 1400/06/01
Expected recruitment end date
2022-02-20, 1400/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of an educational program based on health belief model on self-protection against sexual harassment in children of vulnerable families
Public title
The effect of a health belief model-based educational program on protecting oneself against sexual harassment in children from vulnerable families
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Conscious satisfaction and willingness to participate in educational sessions from parents and children The studied units have 8-11 years old child (third period of childhood) The research units currently reside in the city of Isfahan Research units should not participate in any counseling or psychotherapy program during the treatment intervention Lack of obvious symptoms of psychosis in children and mothers according to the head of the center No chronic illness or other concomitant mental disorders in the research units The presence of the mother in all public educational sessions is mandatory
Exclusion criteria:
Absence from more than one session in training sessions Parents or children do not want to participate in further study Lack of access to the research units during the study for any reason
Age
From 8 years old to 11 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 84
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: cards or envelops shuffling Randomization unit: individual Randomization tool: sealed envelope How to make a random sequence: From among child protection centers, four centers will be selected by lottery. In the centers selected according to the inclusion criteria, among the child protection centers, four centers will be selected based on the lottery. Or the letter chosen by the researcher as the first group and the same number for the second group is considered, then by merging the cards together (folding the cards) a card is taken out and its allocation is recorded, then the cards are merged again. And another card is issued to reach 84 samples
Blinding (investigator's opinion)
Single blinded
Blinding description
The researcher and evaluator of the research outcome is the responsibility of the researcher is blind not to conclude with orientation and identification and sampling of children and their parents will be done by the researcher but for a blinding study, questioning by another person who has the necessary training to complete the questionnaire The goals and objectives of the research seen will be accomplished
Placebo
Not used
Assignment
Parallel
Other design features
Two groups (intervention and control), three stages (before, immediately and 3 months after training)

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
No. 53, Bahar Complex,Asiab Alley,Sheikh Sadough St. North,Isfahan
City
Isfahan
Province
Isfehan
Postal code
8145913151
Approval date
2021-05-24, 1400/03/03
Ethics committee reference number
IR.MUI.NUREMA.REC.1400.026

Health conditions studied

1

Description of health condition studied
Child sexual Abuse
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Self-protection score (awareness and skills) against sexual abuse in children
Timepoint
Before, immediately and 3 months after the intervention (self-protection trainings)
Method of measurement
Self-protection questionnaire (awareness and skills)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: "Intervention group 1:" 6 groups of 7 girls, "Intervention group 2:" 6 groups of 7 boys, training will be shown by showing films related to self-protection, theater, role play. This training will be done in 4 sessions of one and a half hours with a break every 15 minutes for 5 minutes. In the first two sessions, the mother will be present. The mother will not be present. There will also be two special sessions for parents on sex education in the form of lectures and group discussions.
Category
Behavior

2

Description
Control group:"Control group 1:" 6 groups of 7 girls, "Control group 2:" 6 groups of 7 boys, at the end of the study, the training package and the training of the intervention group will be provided to the control group.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Emma
Full name of responsible person
Mohammad Mostajeran
Street address
Omid Educational Complex,Gol Yas Alley,North Hess, North Hess, Roudaki St,Under Third Passage,Airport Highway
City
Isfahan
Province
Isfehan
Postal code
8179918933
Phone
+98 31 3558 1629
Fax
Email
ima.ngo.society@gmail.com
Web page address

2

Recruitment center
Name of recruitment center
Mehre Zenderood
Full name of responsible person
Somayeh Yakhchali
Street address
No. 19, ground floor,dead end (Hamedani),Talab 2 alley,Dark,Isfahan
City
Isfahan
Province
Isfehan
Postal code
8197156671
Phone
+98 31 3551 5609
Fax
+98 31 3331 0389
Email
Mehr_sun87@yahoo.com
Web page address

3

Recruitment center
Name of recruitment center
Population of the people of Salva
Full name of responsible person
Saed Yousefi
Street address
Salva Training Center,Second Hessa, UnderpassAirport Highway,Isfahan
City
Isfahan
Province
Isfehan
Postal code
8164200875
Phone
+98 31 3663 5234
Email
ngo.salva@yahoo.com

4

Recruitment center
Name of recruitment center
Chatrenili
Full name of responsible person
Navid Babaei Kharzooqi
Street address
No. 134, Ground Floor, Nasser Khosrow St., Shahid Molavi Alley, Malekshahr Neighborhood, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8195778111
Phone
+98 31 3425 1780
Email
blue.umbrella.for.children@gmail.com
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Maryam Kianpour
Street address
School of Nursing and Midwifery, Isfahan University of Medical Sciences,Hezar Jerib St.,Isfahan
City
Isfahan
Province
Isfehan
Postal code
۸۱۷۴۶۷۳۴۶۵
Phone
+98 31 3792 7532
Email
kianpour@mail.mui.ac.ir
Web page address
https://mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Zahra Boroumandfar
Position
Faculty of Midwifery and Reproductive Health
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
No. 62,Shahid Mazaheri Alley, Khaghani St.
City
Isfahan
Province
Isfehan
Postal code
۸۱۷۴۶۷۳۴۶۵
Phone
+98 31 3792 7536
Email
boroumandfar@nm.mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Zahra Boroumandfar
Position
Faculty of Midwifery and Reproductive Health
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
No. 62, Shahid Mazaheri,Khaghani St.
City
Isfahan
Province
Isfehan
Postal code
۸۱۷۴۶۷۳۴۶۵
Phone
+98 31 3792 7536
Email
boroumandfar@nm.mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Zahra Shafizadeh
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No. 53, 4th Floor,Bahar Complex,Yas Alley,Asyab Alley, North Sheikh Sadough St.,Isfahan
City
Isfahan
Province
Isfehan
Postal code
8145913151
Phone
+98 31 3663 5234
Email
shzahra95@yahoo.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
Undecided - It is not yet known if there will be 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
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