Effect of Improving Caregiving on Early Mental Health
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
|Official Title:||Effect of Improving Caregiving on Early Mental Health|
- children's physical growth [ Time Frame: 4 to 9+ months ] [ Designated as safety issue: No ]Improved physical growth
- Children's development (mental, motor, social and emotional) [ Time Frame: 4 to 9+ months ] [ Designated as safety issue: No ]Improved behavioral development
|Study Start Date:||April 2000|
|Study Completion Date:||March 2006|
|Primary Completion Date:||March 2006 (Final data collection date for primary outcome measure)|
Experimental: caregiving intervention
One group received caregiving intervention, another received only training, and a third was business as usual. These were the interventions.
Behavioral: Responsive caregiving
Responsive caregiving consisted of operational circumstances and training of caregivers.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00057291
|Baby Home #13|
|St. Petersburg, Canal Gnboedora 98, Russian Federation, 190 068|
|Principal Investigator:||Robert B. McCall||University of Pittsburgh|