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Effect of Improving Caregiving on Early Mental Health
This study is currently recruiting participants.
Verified by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), December 2004
First Received: March 31, 2003   Last Updated: June 23, 2005   History of Changes
Sponsored by: 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

Resource links provided by NLM:


Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:
  • children's physical growth
  • Children's development (mental, motor, social and emotional)

Estimated Enrollment: 1340
Study Start Date: April 2000
Estimated Study Completion Date: March 2005
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.

  Eligibility

Ages Eligible for Study:   up to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • All caregivers and children in three Baby Homes in St. Petersburg, Russia
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00057291

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    
Sponsors and Collaborators
Investigators
Principal Investigator: Robert B. McCall University of Pittsburgh
  More Information

No publications provided

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

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
Orphanage
Caregiving
Training
Child development

Study placed in the following topic categories:
Developmental Disabilities
Mental Disorders
Mental Disorders Diagnosed in Childhood

Additional relevant MeSH terms:
Developmental Disabilities
Mental Disorders
Mental Disorders Diagnosed in Childhood

ClinicalTrials.gov processed this record on July 02, 2009