Evaluation of efficacy of the "Care for Child Development (CCD)" on cognitive, communication, motor and social-emotional skills
Design
Two orphanages from the capital cities of east and west Azerbaijan provinces were selected as control and intervention groups. Children who were between 4- 42 months was selected from each orphanage by random and were matched. "Care for Child Development (CCD)" package was implemented for three sessions a week, each session lasting 2 hours, for three months. CCD was designed by the World Health Organization and UNICEF as an intervention to enhance the development of children. It provides information and recommendation for cognitive stimulation and social support of young children through sensitive and responsive caregiver-child interaction. At the end of the intervention, all of the children in both control and intervention groups were assessed by using Age and Stages Questionnaire(ASQ) and Bayley Diagnostic test (BSID). The BSID is one of the most widely used tools in the world for assessing the growth and development of children at the age of 1 to 42 months which assesses the development of children in 5 domains.
ASQ is a developmental screening tool for children aged 4 to 60 months. It has 19 age-specific questionnaires that assess the child's development in the areas of personal-social skills, motor, communication, and problem-solving skills. Data was compared using T-test analysis
Settings and conduct
This study was done in two orphanages. The intervention group received CCD but the control group didn't.
Participants/Inclusion and exclusion criteria
Children living in orphanage between 4-42 months from the east and west Azerbaijan provinces
Intervention groups
Intervention groups are the ones who received CCD and control groups are the ones who didn't.
Main outcome variables
Children's developmental skills including cognition, motor and communication
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220330054374N1
Registration date:2022-04-20, 1401/01/31
Registration timing:retrospective
Last update:2022-04-20, 1401/01/31
Update count:0
Registration date
2022-04-20, 1401/01/31
Registrant information
Name
Nasrin Baraheni
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3326 3958
Email address
nasrinbaraheni@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-06, 1400/09/15
Expected recruitment end date
2022-03-06, 1400/12/15
Actual recruitment start date
2021-12-19, 1400/09/28
Actual recruitment end date
2022-03-19, 1400/12/28
Trial completion date
2022-03-30, 1401/01/10
Scientific title
The efficacy of “Care for Child Development (CCD)” intervention on Improvement of the developmental skills of orphanage children
Public title
Efficacy of “Care for Child Development (CCD)” on child development
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Chronological age being at the age range of "4-42" months
Living in the orphanage during the study
Exclusion criteria:
Genetic syndromes
Cleft lip and cleft palate
Clear and diagnosed developmental problems
Transfer of the subject's custody to a family,
Being ill and the need for isolation in the orphanage
Being hospitalized
Age
From 4 months old to 42 months old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Actual sample size reached:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Randomizing was done by using random number tables (simple randomization) . After determining the direction of reading the numbers, even numbers were given to Tabriz orphanage and odd numbers were given to Urmiya orphanage.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
In this study cross-sectional research method was used in which some evaluations were done on control and intervention groups by professionals.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
0
City
Tabriz
Province
East Azarbaijan
Postal code
0000000
Approval date
2021-04-22, 1400/02/02
Ethics committee reference number
IR.TBZMED.REC.1399.741
Health conditions studied
1
Description of health condition studied
Developmental Delay
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Developmental skills
Timepoint
At the first and the end of study
Method of measurement
Bayley and ASQ
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Children living in Orphanage between 4-42 months of age
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Orphanages
Full name of responsible person
Zahra bagheri
Street address
Ehsan orphanage, 200 meters to Azad university, Manzariyeh Ave., Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
0000000000
Phone
+98 41 3478 9151
Email
zbagheri041@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Zahra Ebadi
Street address
Tabriz university main street ground floor, central building
City
Tabriz
Province
East Azarbaijan
Postal code
0000000000
Phone
+98 41 3526 2265
Email
Phrc_mb@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Zahra Maleki
Position
Not a faculty member
Latest degree
Master
Other areas of specialty/work
Occupational Therapy
Street address
Tabriz university main street ground floor, central building
City
Tabriz
Province
East Azarbaijan
Postal code
0000000000
Phone
+98 41 3325 4119
Email
zahra.maleki@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Nasrin Baraheni
Position
Not a faculty member
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Tabriz university main street ground floor, central building
City
Tabriz
Province
East Azarbaijan
Postal code
0000000000
Phone
+98 41 3326 3958
Email
nasrinbaraheni@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Zahra Maleki
Position
Not a faculty member
Latest degree
Master
Other areas of specialty/work
Occupational Therapy
Street address
Tabriz university main street ground floor, central building
City
Tabriz
Province
East Azarbaijan
Postal code
0000000000
Phone
+98 41 3325 4119
Email
zahra.maleki@sbmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD