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Effect of Improving Caregiving on Early Mental Health

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00057291
First Posted: April 1, 2003
Last Update Posted: October 29, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
March 31, 2003
April 1, 2003
October 29, 2014
April 2000
March 2006   (Final data collection date for primary outcome measure)
  • 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
  • children's physical growth
  • Children's development (mental, motor, social and emotional)
Complete list of historical versions of study NCT00057291 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Effect of Improving Caregiving on Early Mental Health
Effect of Improving Caregiving on Early Mental Health
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.

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.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Child Development Disorders
Behavioral: Responsive caregiving
Responsive caregiving consisted of operational circumstances and training of caregivers.
Experimental: caregiving intervention
One group received caregiving intervention, another received only training, and a third was business as usual. These were the interventions.
Intervention: Behavioral: Responsive caregiving
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1521
March 2006
March 2006   (Final data collection date for primary outcome measure)

Inclusion Criteria

  • All caregivers and children in three Baby Homes in St. Petersburg, Russia, who remain in the Baby Homes for at least 4 months.
Sexes Eligible for Study: All
up to 85 Years   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Russian Federation
 
 
NCT00057291
5R01HD39017-2
No
Not Provided
Not Provided
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Not Provided
Principal Investigator: Robert B. McCall University of Pittsburgh
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
December 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP