Early Intervention Foster Care: A Prevention Trial (EIFC)
Recruitment status was Active, not recruiting
| Tracking Information | |||||
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| First Received Date ICMJE | June 17, 2008 | ||||
| Last Updated Date | June 18, 2008 | ||||
| Start Date ICMJE | December 1999 | ||||
| Estimated Primary Completion Date | March 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
placement stability [ Time Frame: 6 months to 48 months post-intervention ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00701194 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Early Intervention Foster Care: A Prevention Trial | ||||
| Official Title ICMJE | Early Intervention Foster Care: A Prevention Trial | ||||
| Brief 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention |
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| Condition ICMJE |
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| Intervention ICMJE | 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.
Other Name: Multidemensional Treatment Foster Care-Preschool (MTFC-P) |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | 177 | ||||
| Estimated Completion Date | March 2010 | ||||
| Estimated Primary Completion Date | March 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 3 Years to 6 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00701194 | ||||
| Other Study ID Numbers ICMJE | R01-MH059780 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Philip A. Fisher, Principal Investigator, Oregon Social Learning Center | ||||
| Study Sponsor ICMJE | Oregon Social Learning Center | ||||
| Collaborators ICMJE | National Institute of Mental Health (NIMH) | ||||
| Investigators ICMJE |
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| Information Provided By | Oregon Social Learning Center | ||||
| Verification Date | June 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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