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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00701194
Other study ID # R01MH059780
Secondary ID
Status Active, not recruiting
Phase N/A
First received June 17, 2008
Last updated June 18, 2008
Start date December 1999
Est. completion date March 2010

Study information

Verified date June 2008
Source Oregon Social Learning Center
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

The Early Intervention Foster Care [EIFC] project is an efficacy trial of the Oregon Social Learning Center Multidimensional Treatment Foster Care Program, a preventive intervention that targets 3 commonly co-occurring variables among young foster children: (1) behavioral problems, (2) physiological dysregulation within the neuroendocrine system (i.e., HPA axis activity), and (3) developmental delays.


Description:

The Early Intervention Foster Care project is an ongoing randomized efficacy trial to evaluate the Early Intervention Foster Care Program (EIFC). EIFC, also known at Multidimensional Treatment Foster Care-Preschool (MTFC-P), is a preventive intervention that is specifically designed to address the needs of preschool-aged foster children and their caregivers. Over the first 5 years of the project data was collected from 177 preschool-aged children, 117 of whom were in the Oregon foster care system and 60 of whom were living with their biological families for a community comparison sample. Foster children in the study were randomly assigned to the EIFC experimental intervention condition or a regular foster care condition (RFC). The following hypotheses are under investigation: (1) Relative to children in the RFC condition, children in the EIFC condition will show greater improvements in temporally proximal outcomes (e.g., behavioral/emotional, salivary cortisol, and developmental) and in temporally distal outcomes (e.g., behavioral functioning in the school setting; long-term placement stability, including reunification or adoption; and mental health status, including psychiatric diagnoses). (2) Proximal outcomes over the course of the intervention will predict distal outcomes during the early elementary school years. (3) Proximal outcomes will be mediated by caregivers' childrearing practices—specifically, engagement with and monitoring of the child in the home, the quality and consistency of parental discipline, and the use of positive reinforcement strategies. (4) The same childrearing practices will mediate the psychosocial adjustment of the child in the aftercare setting (i.e., return to family of origin, placement in adoptive home, or continued placement in long-term foster home). (5) The EIFC intervention will cost-effectively reduce the need for mental health and social services for children, decreasing the length of time that children spend in foster care and reducing the need for special education services for children.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 177
Est. completion date March 2010
Est. primary completion date March 2010
Accepts healthy volunteers No
Gender Both
Age group 3 Years to 6 Years
Eligibility Inclusion Criteria:

- child age 3 to 6 years currently in foster care

- child has entered new foster placement

- child currently living in Lane County, Oregon

Exclusion Criteria:

- child is medically or developmentally unable to complete assessment tasks

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Behavioral:
Early Intervention Foster Care (EIFC)
The EIFC/MTFC-P intervention is delivered through a treatment team approach. Foster parents receive preservice training and ongoing consultation from program staff. Children receive individual therapy and attend a therapeutic playgroup. The intervention emphasizes the use of concrete encouragement for prosocial behavior; consistent, nonabusive limit-setting to address disruptive behavior; and close supervision of the child. The EIFC intervention employs a developmental framework in which the challenges of foster preschoolers are viewed from the perspective of delayed maturation and is oriented toward creating optimal environmental conditions to facilitate developmental progress. These conditions include a responsive and consistent caregiver and a predictable daily routine.

Locations

Country Name City State
United States Oregon Social Learning Center Eugene Oregon

Sponsors (2)

Lead Sponsor Collaborator
Oregon Social Learning Center National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary placement stability 6 months to 48 months post-intervention No
Secondary attachment and behavioral regulation baseline through 48 months post-intervention No
Secondary neuroendocrine and executive functioning baseline through 48 months post-intervention No
See also
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Active, not recruiting NCT05736159 - Scientific Justification of Assessment Criteria and Improvement of the Methodology for Assessing School Maturity
Completed NCT01806987 - A Test of the Kids in Transition to School (KITS) Program in Disadvantaged Neighborhoods N/A
Active, not recruiting NCT03081624 - Evaluation of Neurological Status and School Readiness in Preterm Preschoolers N/A
Recruiting NCT06083220 - School Readiness in Preschool-Aged Children With Cerebral Palsy N/A
Completed NCT05140460 - Cultural Pride Reinforcement for Early School Readiness N/A
Completed NCT01593189 - Efficacy Trial of the Kids in Transition to School (KITS) Program for Children With Developmental Disabilities and Behavioral Problems N/A