Adaptation of “Care for Child Development “ program based on response-to- intervention and evaluation of its effectiveness on development skills in at risk children and Caregivers skills
The objective of present study was to investigate The impact of “Care for Child Development “ program on Sensitivity and Responsiveness skills in mothers of children at risk of development delays.In addition, its impact on children's developmental skills is also evaluated
Design
The experimental group was exposed to an Four sessions training of “Care for Child Development “ program but the people in control group received no program
Settings and conduct
Child Developmental Center, Tabriz University of Medical
Sciences,
Participants/Inclusion and exclusion criteria
mothers of children who are at Risk of Developmental Delay
Intervention groups
n this study, the intervention group received three levels of "Child Care Development" program, but the control group did not receive this intervention. Intervention group caregivers received the knowledge and skills needed to care for child development at three levels. At the end of each intervention level, progress and responsiveness to educational interventions were measured, and subjects (children) were either excluded or entered the next level according to the outcome of the intervention
Main outcome variables
the Sensitivity and Responsiveness skills of mothers- development skills in at risk children
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191101045298N1
Registration date:2020-03-05, 1398/12/15
Registration timing:retrospective
Last update:2020-03-05, 1398/12/15
Update count:0
Registration date
2020-03-05, 1398/12/15
Registrant information
Name
Ali Bahari Gharehgoz
Name of organization / entity
Allameh Tabataba'i University
Country
Iran (Islamic Republic of)
Phone
+98 41 3386 2612
Email address
a.bahari@atu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-03, 1398/01/14
Expected recruitment end date
2019-05-22, 1398/03/01
Actual recruitment start date
2019-04-03, 1398/01/14
Actual recruitment end date
2019-06-10, 1398/03/20
Trial completion date
2019-08-23, 1398/06/01
Scientific title
Adaptation of “Care for Child Development “ program based on response-to- intervention and evaluation of its effectiveness on development skills in at risk children and Caregivers skills
Public title
The impact of the program of "Care for Child Development" on child and caregivers
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
children who are at Risk of Developmental Delay
Children in the range of 4 to 36 months
In this study using Convenience Sampling, 50 children under the age of three years who were referred to Tabriz Comprehensive Center for Development were selected and divided randomly(simple randomization- random number table) into two experimental and control groups. reading the table is from top to bottom. even numbers are considered as intervention group and odd numbers are considered as control group
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences
Street address
Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2019-01-07, 1397/10/17
Ethics committee reference number
IR.TBZMED.REC.1397.823
Health conditions studied
1
Description of health condition studied
Children at Risk of Developmental Delay
ICD-10 code
F88
ICD-10 code description
Other disorders of psychological development
Primary outcomes
1
Description
Sensitivity and Responsiveness Skills- Development Skills
Timepoint
Before and After intervention
Method of measurement
The Social-Emotional Assessment/Evaluation Measure Family Profile - Maternal Caregiving Quality Scale -Age and Stages Questionnaires(ASQ)-Bayley
Secondary outcomes
empty
Intervention groups
1
Description
This program is designed by the World Health Organization to empower caregivers. In this program, caregivers stand in need of three basic skills to make the optimum change in child: (1) Sensitivity: being aware of the child's movements, gestures and voice and interpreting it, (2) Responsiveness: responding in a timely manner and qualitatively to the child's signs and symptoms and (3) Learning enrichment and bonding.The number of sessions is four sessions. first : Introduction to program – Concept of development and its aspects - Factors affecting child development - Developmental delay - Child development monitoring.second: Who is caregiver and how can child care be maintained? - Essential skills to care for and improve child development (Sensitivity - Responsiveness and Enriching the Environment).third: Methods of stimulating and boosting child development - Concept and significance of communication - Communication methods - Importance of playing – Support strategies for child play by caregiver – Play things - Types of toys for children.fourth: Play recommendation activities and communication through six age groups - Identifying obstacles and solutions given by program - Final monitoring of development
Category
Behavior
2
Description
The control group received routine care
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz child development center
Full name of responsible person
Ali Bahari Gharehoz
Street address
Tabriz child development center north Tavanir bol., Valiasr , Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3326 3958
Email
alibahari1@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Allameh Tabataba'i University
Full name of responsible person
Mohammad Asgari
Street address
Allameh Tabataba'i University Dehkadeh-ye-Olympic, Tehran, Tehran Provinc
City
Tehran
Province
Tehran
Postal code
۱۴۸۹۶۸۴۵۱۱
Phone
+98 21 4839 3206
Email
drmasgari423@gmail.com
Grant name
Allameh Tabataba'i University
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Allameh Tabataba'i University
Proportion provided by this source
1
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
Tabriz University of Medical Sciences
Full name of responsible person
Ali Bahari Gharehgoz
Position
Non-academic staff
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Tabriz child development center north Tavanir bol., Valiasr , Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3326 3958
Email
a.bahari@atu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ali Bahari Gharehgoz
Position
non-academic staff
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Tabriz child development center north Tavanir bol., Valiasr , Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3326 3958
Email
a.bahari@atu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ali Bahari Gharehgoz
Position
Non-academic staff
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Tabriz child development center north Tavanir bol., Valiasr , Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3326 3958
Email
a.bahari@atu.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
Section of data
When the data will become available and for how long
Six months after publication
To whom data/document is available
Researchers
Under which criteria data/document could be used
Research
From where data/document is obtainable
Email
What processes are involved for a request to access data/document