Viewing Study NCT00057291



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Last Modification Date: 2024-10-26 @ 9:08 AM
Study NCT ID: NCT00057291
Status: COMPLETED
Last Update Posted: 2014-10-29
First Post: 2003-03-31

Brief Title: Effect of Improving Caregiving on Early Mental Health
Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization: Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD

Study Overview

Official Title: Effect of Improving Caregiving on Early Mental Health
Status: COMPLETED
Status Verified Date: 2004-12
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 childrens 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None