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| Sponsor: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
|---|---|
| Information provided by: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
| ClinicalTrials.gov Identifier: | NCT00057291 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Child Development Disorders |
Behavioral: Responsive caregiving |
Phase II |
| Study Type: | Interventional |
| Study Design: | Prevention, Non-Randomized, Open Label, Active Control, Factorial Assignment, Efficacy Study |
| Official Title: | Effect of Improving Caregiving on Early Mental Health |
| Estimated Enrollment: | 1340 |
| Study Start Date: | April 2000 |
| Estimated Study Completion Date: | March 2005 |
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.
Eligibility| Ages Eligible for Study: | up to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Contacts and Locations| Russian Federation, Canal Gnboedora 98 | |
| Baby Home #13 | Recruiting |
| St Petersburg, Canal Gnboedora 98, Russian Federation, 190 068 | |
| Contact: Natalia Nikiforova, MD 310-28-47 babyhome13@mail.rcom.ru | |
| Principal Investigator: | Robert B. McCall | University of Pittsburgh |
More Information
| Study ID Numbers: | 5R01HD39017-2 |
| Study First Received: | March 31, 2003 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00057291 History of Changes |
| Health Authority: | United States: Federal Government |
|
Orphanage Caregiving Training Child development |
|
Developmental Disabilities Mental Disorders Mental Disorders Diagnosed in Childhood |