Evaluating the effect of educating “care for child development guidelines” through a new method to mothers on developmental status of children: A randomized clinical trial
To evaluate the effect of educating "care for child development" guidelines through a new method to mothers on child development
Design
Two arm, parallel groups, randomised, double blinded
Settings and conduct
This trial will be held at Isfahan child development center
Participants/Inclusion and exclusion criteria
Inclusion criteria: Pregnant women in the third trimester who have a healthy child based on clinical and ultrasound evaluations
; Exclusion criteria: Preterm birth (earlier than 37 weeks), birth asphyxia or seizure, Being absent for more than 2 sessions, lack of cooperation for the study, known metabolic or neurological disorders after birth, malnutrition
Intervention groups
The intervention group: The intervention group undergo 5 educational sessions, each lasting for almost 45 minutes. The session will be held during the third trimester of pregnancy (the first session) and 2-6 weeks, 2-6 months, 6-9 months and 9-12 months after delivery, respectively. The educational content of each session is adopted from the Farsi version of CCD manual. In each session, the mother would be trained on how to play and communicate with her child based on the child's age using training materials such as educational slides, toys, etc.
The control group: The control group undergo routine educations on child care, suggested by WHO, which is currently implementing in most of the health centers in the country (through pamphlets and brochures, as well as two to three general skills training sessions such as breastfeeding).
Main outcome variables
BSID-III scores after 1 year
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190128042533N2
Registration date:2020-01-16, 1398/10/26
Registration timing:retrospective
Last update:2020-01-16, 1398/10/26
Update count:0
Registration date
2020-01-16, 1398/10/26
Registrant information
Name
Omid Yaghini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3234 1294
Email address
yaghini@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-17, 1398/07/25
Expected recruitment end date
2019-12-29, 1398/10/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of educating “care for child development guidelines” through a new method to mothers on developmental status of children: A randomized clinical trial
Public title
Evaluating the effect of educating “care for child development guidelines” through a new method to mothers on developmental status of children: A randomized clinical trial
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant women in the third trimester of pregnancy (days 196 to 280 of pregnancy).
Having a healthy child based on clinical and ultrasound evaluations during pregnancy.
Exclusion criteria:
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
266
Randomization (investigator's opinion)
Randomized
Randomization description
Mothers would be divided in to two control and intervention groups. Random numbers would be generated by random allocation software in four blocks. In this method, different conditions of being in the control or intervention group would be considered. Random numbers would be generated, and considering different conditions, patients' allocation to the control or intervention group would be determined.
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 committe of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
۸۱۷۴۶۷۳۴۶۱
Approval date
2018-08-12, 1397/05/21
Ethics committee reference number
IR.MUI.RESEARCH.REC.1397.092
Health conditions studied
1
Description of health condition studied
child development at 12 months of age
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Bayley Scale for Infant Development (BSID)-III score at 1 years of age
Timepoint
when the child is 1 year old
Method of measurement
Bayley Scale for Infant Development (BSID)-III
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:Pregnant women who are included in the study are invited to participate in a session, as the starting session of the study. In this session, general concepts will be discussed including the nutritional needs of children and their developmental status. Then, the intervention group is invited to attend 5 educational sessions, every session lasts 45 minutes. The educational content of each session is adopted from the Farsi version of CCD manual. In each session, mothers are trained to how to play and communicate with their children in each age group. In addition, toys that may be beneficial for children’s development are introduced to mothers and they are encouraged to avoid punishing their children. The control group: The control group undergo routine educations on child care, suggested by WHO, which is currently implementing in most of the health centers in the country (through pamphlets and brochures, as well as two to three general skills training sessions such as breastfeeding).
Category
Behavior
2
Description
Control group: this group take only rotin care in pregnancy and after that take rotin care in health center
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan city primary health care centers
Full name of responsible person
Omid Yaghini
Street address
Child Growth and Development Research Center, Research Institute for Primordial Prevention of Non-communicable Diseases, Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
73461-81746
Phone
+98 31 3792 5280
Email
yaghini@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Omid Yaghini
Street address
Child Growth and Development Research Center, Research Institute for Primordial Prevention of Non-communicable Diseases, Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 5280
Email
yaghini@med.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
80
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
Omid Yaghini
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Neuroscience
Street address
Child Growth and Development Research Center, Research Institute for Primordial Prevention of Non-communicable Diseases, Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 5280
Email
yaghini@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Omid Yaghini
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Neuroscience
Street address
Child Growth and Development Research Center, Research Institute for Primordial Prevention of Non-communicable Diseases, Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 5280
Email
yaghini@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Omid Yaghini
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Neuroscience
Street address
Child Growth and Development Research Center, Research Institute for Primordial Prevention of Non-communicable Diseases, Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5280
Email
yaghini@med.mui.ac.ir
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
Yes - There is 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
Have not decided yet.
When the data will become available and for how long
Have not decided yet.
To whom data/document is available
Have not decided yet.
Under which criteria data/document could be used
Have not decided yet.
From where data/document is obtainable
Have not decided yet.
What processes are involved for a request to access data/document