Effect of Improving Caregiving on Early Mental Health

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2004 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
Recruitment status was  Recruiting
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
First received: March 31, 2003
Last updated: June 23, 2005
Last verified: December 2004

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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Prevention
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.


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

Inclusion Criteria

  • All caregivers and children in three Baby Homes in St. Petersburg, Russia
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00057291

Russian Federation
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
Principal Investigator: Robert B. McCall University of Pittsburgh
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00057291     History of Changes
Other Study ID Numbers: 5R01HD39017-2
Study First Received: March 31, 2003
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

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

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

ClinicalTrials.gov processed this record on October 20, 2014