Effect of Improving Caregiving on Early Mental Health

October 28, 2014 updated by: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

1521

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
    • Canal Gnboedora 98
      • St. Petersburg, Canal Gnboedora 98, Russian Federation, 190 068
        • Baby Home #13

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 85 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
children's physical growth
Time Frame: 4 to 9+ months
Improved physical growth
4 to 9+ months
Children's development (mental, motor, social and emotional)
Time Frame: 4 to 9+ months
Improved behavioral development
4 to 9+ months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Investigators

  • Principal Investigator: Robert B. McCall, University of Pittsburgh

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2000

Primary Completion (Actual)

March 1, 2006

Study Completion (Actual)

March 1, 2006

Study Registration Dates

First Submitted

March 31, 2003

First Submitted That Met QC Criteria

March 31, 2003

First Posted (Estimate)

April 1, 2003

Study Record Updates

Last Update Posted (Estimate)

October 29, 2014

Last Update Submitted That Met QC Criteria

October 28, 2014

Last Verified

December 1, 2004

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5R01HD39017-2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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