Effect of Improving Caregiving on Early Mental Health

Child Development Disorders Clinical Trial

Official title:

Effect of Improving Caregiving on Early Mental Health

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00057291
• Other study ID #: 5R01HD39017-2
• Status: Completed
• Phase: N/A
• First received: March 31, 2003
• Last updated: October 28, 2014
• Start date: April 2000
• Est. completion date: March 2006

Study information

• Verified date: December 2004
• Source: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1521
• Est. completion date: March 2006
• Est. primary completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 85 Years

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Child Development Disorders
• Developmental Disabilities

Intervention

Behavioral:
• Responsive caregiving
Responsive caregiving consisted of operational circumstances and training of caregivers.

Locations

Country	Name	City	State
Russian Federation	Baby Home #13	St. Petersburg	Canal Gnboedora 98

Sponsors (1)

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

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	children's physical growth	Improved physical growth	4 to 9+ months	No
Primary	Children's development (mental, motor, social and emotional)	Improved behavioral development	4 to 9+ months	No