NCT00057291

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,521

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2000

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2000

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

March 31, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 1, 2003

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
Last Updated

October 29, 2014

Status Verified

December 1, 2004

Enrollment Period

5.9 years

First QC Date

March 31, 2003

Last Update Submit

October 28, 2014

Conditions

Child Development Disorders

Keywords

OrphanageCaregivingTrainingChild development

Outcome Measures

Primary Outcomes (2)

  • children's physical growth

    Improved physical growth

    4 to 9+ months

  • Children's development (mental, motor, social and emotional)

    Improved behavioral development

    4 to 9+ months

Study Arms (1)

caregiving intervention

EXPERIMENTAL

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

Behavioral: Responsive caregiving

Interventions

Responsive caregivingBEHAVIORAL

Responsive caregiving consisted of operational circumstances and training of caregivers.

caregiving intervention

Eligibility Criteria

AgeUp to 85 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All caregivers and children in three Baby Homes in St. Petersburg, Russia, who remain in the Baby Homes for at least 4 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baby Home #13

Saint Petersburg, Canal Gnboedora 98, 190 068, Russia

Location

MeSH Terms

Conditions

Developmental Disabilities

Condition Hierarchy (Ancestors)

Neurodevelopmental DisordersMental Disorders

Study Officials

  • Robert B. McCall

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2003

First Posted

April 1, 2003

Study Start

April 1, 2000

Primary Completion

March 1, 2006

Study Completion

March 1, 2006

Last Updated

October 29, 2014

Record last verified: 2004-12

Locations

RU(1)