Effect of Improving Caregiving on Early Mental Health
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|ClinicalTrials.gov Identifier: NCT00057291|
Recruitment Status : Completed
First Posted : April 1, 2003
Last Update Posted : October 29, 2014
|Condition or disease||Intervention/treatment||Phase|
|Child Development Disorders||Behavioral: Responsive caregiving||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1521 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Effect of Improving Caregiving on Early Mental Health|
|Study Start Date :||April 2000|
|Actual Primary Completion Date :||March 2006|
|Actual Study Completion Date :||March 2006|
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.
- children's physical growth [ Time Frame: 4 to 9+ months ]Improved physical growth
- Children's development (mental, motor, social and emotional) [ Time Frame: 4 to 9+ months ]Improved behavioral development
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00057291
|Baby Home #13|
|St. Petersburg, Canal Gnboedora 98, Russian Federation, 190 068|
|Principal Investigator:||Robert B. McCall||University of Pittsburgh|