Effect of Improving Caregiving on Early Mental Health

Tracking Information

Start Date  ICMJEApril 2000
Primary Completion Date 
Current Primary Outcome Measures  ICMJE 
 (submitted: June 23, 2005)
  • children's physical growth
  • Children's development (mental, motor, social and emotional)
Original Primary Outcome Measures  ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00057291 on ClinicalTrials.gov Archive Site

Descriptive Information

Brief Title  ICMJEEffect of Improving Caregiving on Early Mental Health
Official Title  ICMJEEffect of Improving Caregiving on Early Mental Health
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.

Study PhasePhase II
Study Type  ICMJEInterventional
Study Design  ICMJEPrevention, Non-Randomized, Open Label, Active Control, Factorial Assignment, Efficacy Study
Condition  ICMJEChild Development Disorders
Intervention  ICMJEBehavioral: Responsive caregiving

Recruitment Information

Enrollment  ICMJE1340
Completion DateMarch 2005
Primary Completion Date 
Eligibility Criteria  ICMJE

Inclusion Criteria

  • All caregivers and children in three Baby Homes in St. Petersburg, Russia
Agesup to 85 Years
Accepts Healthy VolunteersNo
Contacts  ICMJE 
Location Countries  ICMJERussian Federation

Administrative Information

Responsible Party 
Study ID Numbers  ICMJE5R01HD39017-2
Study Sponsor  ICMJEEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborators  ICMJE 
Investigators  ICMJE
Principal Investigator:Robert B. McCallUniversity of Pittsburgh
Information Provided ByEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)