Effect of Improving Caregiving on Early Mental Health

NCT ID: NCT00057291

Last Updated: 2014-10-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1521 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-04-30
• Study Completion Date: 2006-03-31

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.

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.

Conditions

Child Development Disorders

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

caregiving intervention

One group received caregiving intervention, another received only training, and a third was business as usual. These were the interventions.

Group Type: EXPERIMENTAL

Responsive caregiving

Intervention Type: BEHAVIORAL

Responsive caregiving consisted of operational circumstances and training of caregivers.

Interventions

Responsive caregiving

Responsive caregiving consisted of operational circumstances and training of caregivers.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert B. McCall

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

Baby Home #13

Saint Petersburg, Canal Gnboedora 98, Russia

Countries

Russia

Other Identifiers

5R01HD039017

Identifier Type: NIH

Identifier Source: secondary_id

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5R01HD39017-2

Identifier Type: -

Identifier Source: org_study_id