- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00701194
Early Intervention Foster Care: A Prevention Trial (EIFC)
June 18, 2008 updated by: Oregon Social Learning Center
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
177
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
-
-
Oregon
-
Eugene, Oregon, United States, 97401
- Oregon Social Learning Center
-
-
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
3 years to 6 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 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: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
EIFC/MTFC-P
|
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.
Other Names:
|
No Intervention: 2
Services as usual
|
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.
Other Names:
|
No Intervention: Community Comparison
Non-maltreated community pre-schoolers from low-income biological families.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
placement stability
Time Frame: 6 months to 48 months post-intervention
|
6 months to 48 months post-intervention
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
attachment and behavioral regulation
Time Frame: baseline through 48 months post-intervention
|
baseline through 48 months post-intervention
|
neuroendocrine and executive functioning
Time Frame: baseline through 48 months post-intervention
|
baseline through 48 months post-intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Philip A Fisher, PhD, Oregon Social Learning Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
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
December 1, 1999
Primary Completion (Anticipated)
March 1, 2010
Study Completion (Anticipated)
March 1, 2010
Study Registration Dates
First Submitted
June 17, 2008
First Submitted That Met QC Criteria
June 18, 2008
First Posted (Estimate)
June 19, 2008
Study Record Updates
Last Update Posted (Estimate)
June 19, 2008
Last Update Submitted That Met QC Criteria
June 18, 2008
Last Verified
June 1, 2008
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- R01MH059780 (U.S. NIH Grant/Contract)
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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