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IRCT20190128042533N2 IRCT 2020-01-16 Esfahan University of Medical Sciences 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 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 2019-10-17 anticipated 266 Complete https://irct.ir/trial/42923 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, 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. N/A child development at 12 months of age. Intervention 1: 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). Intervention 2: Control group: this group take only rotin care in pregnancy and after that take rotin care in health center. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Have not decided yet.
public Omid Yaghini
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
Isfahan Iran (Islamic Republic of) 81746-73461 +98 31 3792 5280 yaghini@med.mui.ac.ir Esfahan University of Medical Sciences scientific Omid Yaghini
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
Isfahan Iran (Islamic Republic of) 81746-73461 +98 31 3792 5280 yaghini@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) 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. 18 years 45 years Female Behavior Rehabilitation 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). Control group: this group take only rotin care in pregnancy and after that take rotin care in health center 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. Esfahan University of Medical Sciences Approved 2018-08-12 Ethics committe of Isfahan University of Medical Sciences Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan, Iran Isfahan Isfehan Iran (Islamic Republic of)