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Effect of Improving Caregiving on Early Mental Health - Article


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Child Behavior Disorders

Bullying


Clinical Trial: Effect of Improving Caregiving on Early Mental Health

This study is currently recruiting patients.

Sponsored by: National Institute of Child Health and Human Development (NICHD)
Information provided by: National Institute of Child Health and Human Development (NICHD)

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 Treatment or Intervention Phase
Child Development Disorders
 Behavior: Responsive caregiving
Phase II

MedlinePlus related topics:  Developmental Disabilities

Study Type: Interventional
Study Design: Prevention, Non-Randomized, Open Label, Active Control, Factorial Assignment, Efficacy Study

Further Study Details: 
Primary Outcomes: children's physical growth; Children's development (mental, motor, social and emotional)
Expected Total Enrollment:  1340

Study start: April 2000;  Expected completion: March 2005
Last follow-up: March 2005;  Data entry closure: 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

Criteria

Inclusion Criteria

  • All caregivers and children in three Baby Homes in St. Petersburg, Russia

Location and Contact Information


Russian Federation, Canal Gnboedora 98
      Baby Home #13, St Petersburg,  Canal Gnboedora 98,  190 068,  Russian Federation; Recruiting
Natalia Nikiforova, MD  310-28-47    babyhome13@mail.rcom.ru 

Study chairs or principal investigators

Robert B. McCall,  Principal Investigator,  University of Pittsburgh   

More Information

Study ID Numbers:  5R01HD39017-2
Record last reviewed:  December 2004
Last Updated:  December 9, 2004
Record first received:  March 31, 2003
ClinicalTrials.gov Identifier:  NCT00057291
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005


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Page Updated: September 6, 2005
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