Ccd is basically a child development care program in the form of behavioral intervention and caregiver interaction with the child
Design
A clinical trial with a control group with parallel groups, two-way blind صهفا randomization, on 1000 children and their parents
Settings and conduct
The study method is a mixed study.
CCD is basically a child development care program in the form of behavioral intervention and caregiver interaction with the child.Execution steps include:
1.Situational analysis of early childhood developmental status (ECD) of young children (prenatal up to 3 years)
2. Holding a panel of experts
3. Design CCD instructions and approve it by experts
4. Holding an introductory training workshop
5. Holding the compliance panel in the presence of all stakeholders
6. The program begins with the supervision of the Ministry of Health, in other words, the intervention.
In this phase, the instructors, who during the two introductory workshops and the instructor training workshop that was held in the previous stages, train people to provide services in the form of internal and intra-provincial workshops. The qualitative stage has been determined before the panel of experts.
The result and effectiveness of the service is evaluated with the help of monitoring and evaluation tools that have been prepared and standardized in the previous step.
Participants/Inclusion and exclusion criteria
All children under the age of three and their parents, health care providers, and child care providers in designated centers for sampling are candidates for inclusion in the study. The unwillingness of parents to cooperate will prevent them from entering.
Intervention groups
parents
caregivers
children
Main outcome variables
The effectiveness of CCD service on parents' knowledge and attitude
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100503003857N2
Registration date:2022-05-23, 1401/03/02
Registration timing:registered_while_recruiting
Last update:2022-05-23, 1401/03/02
Update count:0
Registration date
2022-05-23, 1401/03/02
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
61192357
Email address
mshariat@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-20, 1400/12/01
Expected recruitment end date
2022-06-22, 1401/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Adaptation and Implementation of " Care for Child Development" (CCD) intervention in the health system and Nurseries
Public title
Adaptation and Implementation of " Care for Child Development" (CCD) intervention
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
All children under the age of three with seemingly healthy development (ASQ scores above minus 2 in all developmental areas) can participate in this program.
The caregiving mothers, nurses, and pregnant mothers with relative physical and mental health are also eligible to participate in the program.
Exclusion criteria:
In any part of the study, if the child is found to be developmentally delayed or disturbed, or if the caregiver has a serious mental or physical health problem that may interfere with communication and play with the child, the caregiver and the child will be excluded from the study. After exclusion, this mother or child will be referred for specialized services.
Age
To 3 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
1000
More than 1 sample in each individual
Number of samples in each individual:
2
Interviewing and filling out questionnaires before and after counseling and training sessions
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be simple using the table of random numbers in EXCEL software.
Blinding (investigator's opinion)
Double blinded
Blinding description
The parents of the two intervention and control groups are unaware of the quantity and quality of education received in the other group and are unaware that education is part of the study process or is a routine instruction received by all parents. Also, the outcome assessor is unaware of the assignment of each child to each group during the study period and only monitors and reports on the child's developmental status.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
the Ethics committee of Imam-Khomeini Hospital Complex, Tehran University of Medical Sciences
Street address
Keshavarz Blvd., Intersection of Dr. Gharib Street
City
Tehran
Province
Tehran
Postal code
1419733141
Approval date
2021-06-16, 1400/03/26
Ethics committee reference number
IR.TUMS.IKHC.REC.1400.093
Health conditions studied
1
Description of health condition studied
adapting and implementing " Care for Child Development" (CCD) intervention in the health system and children’s institutional care system of Iran
ICD-10 code
ICD-10 code description
2
Description of health condition studied
knowledge and skills of caregivers
ICD-10 code
ICD-10 code description
3
Description of health condition studied
knowledge and skills of health care providers, care givers, and midwives
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The effectiveness of CCD service on parents' knowledge and attitude
Timepoint
Prior to the consultation, pre-intervention evaluations will be performed with valid questionnaires. This consultation will be done twice and two weeks apart for the caregiver. After the second consultation, the evaluation will be performed two months after the intervention.
Method of measurement
Tool No. 1: Checklist of Counseling for Care for Child Development. Tool No. 5: Family Environment Assessment. Tool No. 6: Parent’s Sensitivity and Responsiveness Questionnaire. Tool No. 7: Mother's Knowledge and Attitude Questionnaire. Tool No. 8: Pre-Test and Post-Test Used in the TOT Workshop
Secondary outcomes
1
Description
The effectiveness of CCD service on the skills of caregivers
Timepoint
The caregiver skills assessment will be performed before and after the intervention. A follow-up evaluation will be performed two months after the end of the sessions.
Method of measurement
Tool No. 2: Caregiver (Parent) Report of the Service Provider Skills. Tool No. 3: Interview with the Service Provider. Tool No. 4: Service Provider Skills Observation Questionnaire
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
UNICEF organization
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Foreign
Category of foreign source of funding
UN agencies and international organizations
Country of origin
Type of organization providing the funding
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mamak Shariat
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Others
Street address
Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2052
Email
mshariat@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mamak Shariat
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Others
Street address
Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2052
Email
mshariat@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mamak Shariat
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Others
Street address
Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2052
Email
mshariat@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
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The information entered in each tool examined at any stage of the study can be shared by all individuals after unidentified individuals.
When the data will become available and for how long
After preparing the report and article resulting from the plan
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
If the person in question provides sufficient explanations of the type of data use, the data will be provided to him after sending a written request. For example, continuing the study process in children over 3 years old.
From where data/document is obtainable
Sending a written and official request to the person responsible for data collection and maintenance to the email address mshariat@tums.ac.ir
What processes are involved for a request to access data/document
After submitting the request and examining how to use the data in consultation with the project partners, the data will be provided to the applicant within a maximum of one month.