We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Effect of Improving Caregiving on Early Mental Health

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.
ClinicalTrials.gov Identifier: NCT00057291
Recruitment Status : Completed
First Posted : April 1, 2003
Last Update Posted : October 29, 2014
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Child Development Disorders Behavioral: Responsive caregiving

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1521 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Effect of Improving Caregiving on Early Mental Health
Study Start Date : April 2000
Primary Completion Date : March 2006
Study Completion Date : March 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: caregiving intervention
One group received caregiving intervention, another received only training, and a third was business as usual. These were the interventions.
Behavioral: Responsive caregiving
Responsive caregiving consisted of operational circumstances and training of caregivers.

Outcome Measures

Primary Outcome Measures :
  1. children's physical growth [ Time Frame: 4 to 9+ months ]
    Improved physical growth

  2. Children's development (mental, motor, social and emotional) [ Time Frame: 4 to 9+ months ]
    Improved behavioral development

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   up to 85 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00057291

Russian Federation
Baby Home #13
St. Petersburg, Canal Gnboedora 98, Russian Federation, 190 068
Sponsors and Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Principal Investigator: Robert B. McCall University of Pittsburgh
More Information

Responsible Party: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier: NCT00057291     History of Changes
Other Study ID Numbers: 5R01HD39017-2
First Posted: April 1, 2003    Key Record Dates
Last Update Posted: October 29, 2014
Last Verified: December 2004

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

Additional relevant MeSH terms:
Developmental Disabilities
Neurodevelopmental Disorders
Mental Disorders