Tracking Information
Start Date ICMJE | April 2000 |
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Primary Completion Date | |
Current Primary Outcome Measures ICMJE (submitted: June 23, 2005) |
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Original Primary Outcome Measures ICMJE | Same as current |
Change History | Complete list of historical versions of study NCT00057291 on ClinicalTrials.gov Archive Site |
Descriptive Information
Brief Title ICMJE | Effect of Improving Caregiving on Early Mental Health |
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Official Title ICMJE | Effect of Improving Caregiving on Early Mental Health |
Brief Summary | 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. |
Detailed Description | 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 Phase | Phase II |
Study Type ICMJE | Interventional |
Study Design ICMJE | Prevention, Non-Randomized, Open Label, Active Control, Factorial Assignment, Efficacy Study |
Condition ICMJE | Child Development Disorders |
Intervention ICMJE | Behavioral: Responsive caregiving |
Recruitment Information
Enrollment ICMJE | 1340 |
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Completion Date | March 2005 |
Primary Completion Date | |
Eligibility Criteria ICMJE | Inclusion Criteria
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Gender | Both |
Ages | up to 85 Years |
Accepts Healthy Volunteers | No |
Contacts ICMJE | |
Location Countries ICMJE | Russian Federation |
Administrative Information
NCT ID ICMJE | NCT00057291 | ||||
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Responsible Party | |||||
Study ID Numbers ICMJE | 5R01HD39017-2 | ||||
Study Sponsor ICMJE | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |