Effect of Improving Caregiving on Early Mental Health
Primary Purpose
Child Development Disorders
Status
Completed
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Responsive caregiving
Sponsored by
About this trial
This is an interventional basic science trial for Child Development Disorders focused on measuring Orphanage, Caregiving, Training, Child development
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.
Sites / Locations
- Baby Home #13
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
caregiving intervention
Arm Description
One group received caregiving intervention, another received only training, and a third was business as usual. These were the interventions.
Outcomes
Primary Outcome Measures
children's physical growth
Improved physical growth
Children's development (mental, motor, social and emotional)
Improved behavioral development
Secondary Outcome Measures
Full Information
NCT ID
NCT00057291
First Posted
March 31, 2003
Last Updated
October 28, 2014
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1. Study Identification
Unique Protocol Identification Number
NCT00057291
Brief Title
Effect of Improving Caregiving on Early Mental Health
Official Title
Effect of Improving Caregiving on Early Mental Health
Study Type
Interventional
2. Study Status
Record Verification Date
December 2004
Overall Recruitment Status
Completed
Study Start Date
April 2000 (undefined)
Primary Completion Date
March 2006 (Actual)
Study Completion Date
March 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Child Development Disorders
Keywords
Orphanage, Caregiving, Training, Child development
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1521 (Actual)
8. Arms, Groups, and Interventions
Arm Title
caregiving intervention
Arm Type
Experimental
Arm Description
One group received caregiving intervention, another received only training, and a third was business as usual. These were the interventions.
Intervention Type
Behavioral
Intervention Name(s)
Responsive caregiving
Intervention Description
Responsive caregiving consisted of operational circumstances and training of caregivers.
Primary Outcome Measure Information:
Title
children's physical growth
Description
Improved physical growth
Time Frame
4 to 9+ months
Title
Children's development (mental, motor, social and emotional)
Description
Improved behavioral development
Time Frame
4 to 9+ months
10. Eligibility
Sex
All
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert B. McCall
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baby Home #13
City
St. Petersburg
State/Province
Canal Gnboedora 98
ZIP/Postal Code
190 068
Country
Russian Federation
12. IPD Sharing Statement
Learn more about this trial
Effect of Improving Caregiving on Early Mental Health
We'll reach out to this number within 24 hrs