Evaluate the effectiveness of counseling led by midwife on mother's participation in the sexual education of preschool children
Design
randomized controlled clinical trial with a pre-posttest design
Settings and conduct
Population comprise mothers with preschool children at Alborz University of Medical Sciences . A sample of 60 mothers who met the inclusion criteria will be selected by simple random. In intervention group, participants will attend weekly in group counselling session for 3 sessions (90 minutes) in groups of six people, according the active learning model.The participants will be evaluated before and two weeks after the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: being Iranian, being iterated, being employed at Alborz university of medical sciences, being interested to contribute in the study. Exclusion criteria:failure to complete questionnaires, not attending at least 1 sessions of counseling sessions .
Intervention groups
In the study group, participants with entry criteria, who will receive weekly group counseling in 3 sessions (90 minutes).Control group no advice is given to individuals.
Main outcome variables
Mother's participation in child sexual education
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160424027557N7
Registration date:2018-08-20, 1397/05/29
Registration timing:registered_while_recruiting
Last update:2018-08-20, 1397/05/29
Update count:0
Registration date
2018-08-20, 1397/05/29
Registrant information
Name
Mahnaz Akbari Kamrani
Name of organization / entity
Alborz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 26 3433 6007
Email address
dr.akbarikamrani@abzums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-18, 1397/04/27
Expected recruitment end date
2018-10-22, 1397/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of counseling led by midwife on mother's participation in the sexual education of preschool children
Public title
Effect of counseling on the child sexual education
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
being employed at Alborz university of medical sciences
being literated
being Iranian
not having a history of attending child sexual training courses
being interested to contribute in the study
Exclusion criteria:
failure to complete questionnaires
not attending at least 1 sessions of counseling sessions
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Use block randomization
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
Alborz University of Medical Sciences
Street address
Research& Technology Office., Alborz University of Medical Science., Yasamin St., Poneh St., Golshahr BLv
City
karaj
Province
Alborz
Postal code
3149779453
Approval date
2018-01-20, 1396/10/30
Ethics committee reference number
Abzums.Rec.1396.163
Health conditions studied
1
Description of health condition studied
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Mother's participation about child sexual education
Timepoint
Before and after intervention
Method of measurement
Mother's participation questionnaire on sex education for children
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Participants will attend weekly in the group counselling session for 3 sessions (90 minutes) in groups of six people, according the active learning model. Counselling content includes: the purpose of the study, child sexual education, mother role in sexual education, child sexual behaviour and child communication skills.
Category
Behavior
2
Description
Control group: Participants will not receive any intervention. After the study, a booklet containing the content of the consultation is given to them.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Alborz University of Medical Sciences
Full name of responsible person
Hadis Fatehi Poladi
Street address
Education Office., Alborz University of Medical Science., Taleghani BLv
City
karaj
Province
Alborz
Postal code
3149779453
Phone
+98 21 4447 7430
Email
h.fatehi.p@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Alborz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Noorisepehr
Street address
Research& Technology Office., Alborz University of Medical Science., Yasamin St., Poneh St., Golshahr BLv
City
Karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 3455 1034
Email
researchabzums.ac.ir-info@abzums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Alborz 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
Alborz University of Medical Sciences
Full name of responsible person
Hadis Fatehi Poladi
Position
Student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Medicine Faculty., Nabovat Square
City
Karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 3428 7463
Email
h.fatehi.p@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Alborz University of Medical Sciences
Full name of responsible person
Dr. Mahnaz Akbari Kamrani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Medicine Faculty., Nabovat Square
City
Karaj
Province
Alborz
Postal code
3149779543
Phone
+98 26 3428 7463
Email
Dr.akbarikamrani@abzums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Alborz University of Medical Sciences
Full name of responsible person
Dr. Mahnaz Akbari Kamrani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Medicine Faculty., Nabovat Street
City
Karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 3428 7463
Email
Dr.akbarikamrani@abzums.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
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
all collected variables
When the data will become available and for how long
From 2019
To whom data/document is available
It is available only for people working in academic institutions.
Under which criteria data/document could be used
No Criterion
From where data/document is obtainable
By Email: Dr.akbarikamrani@abzums.ac.ir and Dr. Mahnaz Akbari Kamrani would be responsive
What processes are involved for a request to access data/document