Determining the effect of children’s sexual nurturing program on parent’s self-efficacy
Design
Theis research is a randomized clinical trial with two groups; intervention and control. Sampling will be conducted by simple random allocation.Total sample was estimated 40 parents in each group (mother or father).
Settings and conduct
The research environment will be all of the Shahr-e- Rey Municipality affiliated Saraye Mahals. The research community includes all children parents attending the Saraye Mahale. Sample of study will be randomly selected from eligible parents. Intervention group will receive 4 weekly group sessions based on educational program. The control group will not receive any intervention until at the end of the research.
Participants/Inclusion and exclusion criteria
Being Iranian; having at least one child under 7 years old; having the ability to reading and writing; not attending child's sexual training programs; not having psychological illness; not consuming psychological drugs.
Intervention groups
The intervention group will receive 4 weekly group sessions based on educational program. Duration of each session will be 60-90 minutes. The control group will not receive any intervention until the end of the research. After that, based on the ethics of the research and their willingness, the child sexual nurturing educational program will be presented by the researcher.
Main outcome variables
Parental knowledge; parental situational understanding; parental self-control and parental self-efficacy
General information
Reason for update
Acronym
ندارد
IRCT registration information
IRCT registration number:IRCT20160808029255N5
Registration date:2018-09-27, 1397/07/05
Registration timing:registered_while_recruiting
Last update:2018-09-27, 1397/07/05
Update count:0
Registration date
2018-09-27, 1397/07/05
Registrant information
Name
Raziyeh Maasoumi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6105 4214
Email address
r_masoumi@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-23, 1397/05/01
Expected recruitment end date
2019-02-20, 1397/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of children’s sexual nurturing program on parent’s self-efficacy
Public title
The effect of children’s sexual nurturing program on parent’s self-efficacy
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Being Iranian
Having at least one child under 7 years old
Having the ability to reading and writing
Exclusion criteria:
Attending child's sexual training programs
Having psychological illness
Using psychological drugs
Age
From 18 years old to 49 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling will be conducted by Simple random allocation. After identification of individuals who have eligible to enter thee study, each person will select one card among cards which including A or B character. In person select a cord with A character it means she/he will be included to the intervention group and if the card with B character be selected the person will be included to the control group. this process will be continue to all of sample classified in two 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 Tehran University of Medical Sciences Nursing and Midwifery Care Research Center
Street address
Faculty of Nursing and Midwifery, South Nosrat Ave., Towhid Sq.
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2018-07-01, 1397/04/10
Ethics committee reference number
IR.TUMS.FNM.REC.1397.032
Health conditions studied
1
Description of health condition studied
Parental knowledge
ICD-10 code
ICD-10 code description
2
Description of health condition studied
Parental situational understanding
ICD-10 code
ICD-10 code description
3
Description of health condition studied
Parental self-control
ICD-10 code
ICD-10 code description
4
Description of health condition studied
Parental self-efficacy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Parental knowledge means the amount of information and awareness of the parent about why and what is the child sexual nurturing
Timepoint
Before the intervention, 4 and 8 weeks after the intervention
Method of measurement
The first sub-scale of the researcher- made Questionnaire
2
Description
Parental situational understanding means parental ability for differentiating normal sexual behaviors from sexual behavior problems
Timepoint
Before the intervention, 4 and 8 weeks after the intervention
Method of measurement
The second sub-scale of researcher- made Questionnaire
3
Description
Self-control means the parental ability to control her/his inappropriate responses such as anger, deny and etc...to child's sexual behaviors when exposed
Timepoint
Before the intervention, 4 and 8 weeks after the intervention
Method of measurement
The third sub-scale of researcher- made Questionnaire
4
Description
Self-efficacy means parent's belief about her/his capability to differentiate normal sexual behaviors from sexual behavior problems, managing such behaviors and using copying strategies in child sexual nurturing to guide the child through the sexual developmental stages without any serious problem
Timepoint
Before the intervention, 4 and 8 weeks after the intervention
Method of measurement
The fourth subscale of researcher- made Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:The intervention group will receive child sexual nurturing educational program based on group training during four sessions. Duration of each session will be 60-90 minutes.
Category
N/A
2
Description
Control group:The control group will not receive any intervention until the end of the research. Then, based on the ethics of the research and their willingness the child sexual nurturing educational program will be presented by the researcher.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Saraye Mahale Shahadat
Full name of responsible person
Raziyeh Masoomi
Street address
Saraye Mahal-e Shahadat, Mehran Park., Dolat Abad First Square., Shahr-e-Rey
Dr. Sahraian, the Vice Chancellor of Research at Tehran University of Medicine Sciences
Street address
Keshavarz Blv., Qods St.,
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3698
Email
msahrai@sina.tums.ac.ir
Web page address
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
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
Tehran University of Medical Sciences
Full name of responsible person
Raziyeh Maasoumi
Position
Assisstant Proffesor
Latest degree
Ph.D.
Other areas of specialty/work
Sexology, Sexual and Reproductive Health
Street address
Faculty of Nursing and Midwifery, East Nosrath., Towhid Sq.,
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4214
Email
r_masoumi@sina.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Raziyeh Maasoumi
Position
Assisstant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sexology, Sexual and Reproductive Health
Street address
Faculty of Nursing and Midwifery, East Nosrath., Towhid Sq.,
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4214
Email
r_masoumi@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Raziyeh Maasoumi
Position
Assisstant Professor
Latest degree
Ph.D.
Other areas of specialty/work
سکسولوژی، سلامت جنسی و باروری
Street address
Faculty of Nursing and Midwifery, East Nosrath., Towhid Sq.,
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4214
Email
r_masoumi@sina.tums.ac.ir
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
Not applicable
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Data of the study would be available after unrecognizable process of participants.
When the data will become available and for how long
6 months after publishing the results
To whom data/document is available
Research results would be available for academic researchers
Under which criteria data/document could be used
Research results would be available for same researches
From where data/document is obtainable
Dr. Raziyeh Maasoumi email: r_masoumi@sina.tums.ac.ir
What processes are involved for a request to access data/document
Sending a request by email attendance to the office of corresponding of project presentation the reasons for similarity of two projects studying the proposal by corresponding of project final decision making with corresponding author access of data in office of corresponding author