Child Development Disorders Clinical Trial
Official title:
Effect of Improving Caregiving on Early Mental Health
This study evaluates the effect on children and caregivers of providing training in warm, sensitive, responsive caregiving to caregivers in three orphanages in St. Petersburg, Russia. The study also assesses the effectiveness of having more consistent care from fewer caregivers in a family-like environment.
This project will provide experimental evidence that warm, sensitive, responsive caregiving
and structural changes that promote more consistent and fewer caregivers will lead to better
physical, mental, social, and emotional development of young children. Structural changes
are designed to facilitate a more family-like environment and include smaller group sizes,
more consistent caregiving from fewer caregivers, integration by age and disability status,
and establishing two daily 60-minute Family Hours in which children and caregivers interact
together. The project also attempts to demonstrate that training caregivers can be
beneficial to both caregivers and children.
All caregivers and children in three orphanages for children under 4 years old in St.
Petersburg, Russia will participate in this study. One orphanage will implement both
training and structural changes. A second orphanage will receive training only. The third
orphanage will serve as a control, receiving neither training nor structural changes.
Caregivers are assessed annually for attitudes to and problems with their jobs; anxiety and
depression; coping styles; traditional versus progressive attitudes toward caregiving;
sensitivity to children's emotions; values; and perceptions of their own relationships.
Children are assessed at 3, 6, 9, 12, 18, 24, 36, and 48 months for physical growth, chronic
and acute disorders, functional abilities, and mental, motor, social, and emotional
development.
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
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