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IRCT20100503003857N2 IRCT 2022-05-23 Tehran University of Medical Sciences Adaptation and Implementation of " Care for Child Development" (CCD) intervention Adaptation and Implementation of " Care for Child Development" (CCD) intervention in the health system and Nurseries 2022-02-20 anticipated 1000 Complete https://irct.ir/trial/63385 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Randomization description: Randomization will be simple using the table of random numbers in EXCEL software, 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. 3 Condition 1: adapting and implementing " Care for Child Development" (CCD) intervention in the health system and children’s institutional care system of Iran. Condition 2: knowledge and skills of caregivers. Condition 3: knowledge and skills of health care providers, care givers, and midwives. Intervention 1: Intervention group: Parents receiving counseling sessions. Intervention 2: Control group: Lack of counseling sessions. Yes - There is a plan to make this available What will be shared: The information entered in each tool examined at any stage of the study can be shared by all individuals after unidentified individuals. When: After preparing the report and article resulting from the plan To whom: Researchers working in academic and scientific institutions Conditions: 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. Where to obtain: Sending a written and official request to the person responsible for data collection and maintenance to the email address mshariat@tums.ac.ir How to obtain: 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. Comments:
public Mamak Shariat
Keshavarz Blvd.
Tehran Iran (Islamic Republic of) 1419733141 +98 21 6119 2052 mshariat@tums.ac.ir Tehran University of Medical Sciences scientific Mamak Shariat
Keshavarz Blvd.
Tehran Iran (Islamic Republic of) 1419733141 +98 21 6119 2052 mshariat@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) 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. no limit 3 years Both 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. Behavior Behavior Intervention group: Parents receiving counseling sessions Control group: Lack of counseling sessions 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. 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. UNICEF organization Approved 2021-06-16 the Ethics committee of Imam-Khomeini Hospital Complex, Tehran University of Medical Sciences Keshavarz Blvd., Intersection of Dr. Gharib Street Tehran Tehran Iran (Islamic Republic of)