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Trial of KEEP-P, a Preventive Intervention for Foster Preschoolers (KEEP-P) (KEEP-P)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2017 by Phil Fisher, University of Oregon
Sponsor:
Collaborator:
Oregon Social Learning Center
Information provided by (Responsible Party):
Phil Fisher, University of Oregon
ClinicalTrials.gov Identifier:
NCT03106636
First received: June 4, 2015
Last updated: April 14, 2017
Last verified: April 2017
  Purpose
Randomized Trial of KEEP-P, a Preventive Intervention for Foster Preschoolers (KEEP-P). The goal of the proposed study is to conduct a randomized clinical trial of a new, low-cost, manualized, group-based intervention for preschoolers and their caregivers. The investigators will examine the extent to which the two intervention conditions show improved parenting, reduced rates of disrupted placements, and improved child outcomes.

Condition Intervention
Child Behavior
Behavioral: KEEP-P
Behavioral: KEEP-P+

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Outcomes Assessor
Primary Purpose: Prevention
Official Title: Randomized Trial of KEEP-P, a Preventive Intervention for Foster Preschoolers

Resource links provided by NLM:


Further study details as provided by Phil Fisher, University of Oregon:

Primary Outcome Measures:
  • Improved Parenting Behaviors [ Time Frame: Change from baseline at 4, 12 and 18 months post-baseline. ]
    Improvement on caregiver measures including increases in skill in behavior management, use of family routines, parenting sense of competence, supportive parenting and mindfulness in parenting as well as decreases in parenting stress.


Secondary Outcome Measures:
  • Reduced rates of disrupted foster placements [ Time Frame: Change from baseline at 4, 12 and 18 months post-baseline. ]
    Oregon DHS Child Welfare Services (CWS) records will be inspected to assess the children's history of caregiver transitions. These detailed records, are used to reimburse foster caregivers for the children in their care and to track the children's entries into and exits from different foster care placements, will allow the investigators to compute variables of interest (e.g., number of different caregivers, number of transitions from biological parents to foster caregivers and transitions within the foster care system, and length of time spent with each caregiver).

  • Improved child behavioral and social adjustment [ Time Frame: Change from baseline at 4, 12 and 18 months post-baseline. ]
    Improvement on child measures of developmental status, social skills, attachment to caregiver and decreases in child problem behavior.


Estimated Enrollment: 240
Study Start Date: February 2014
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: KEEP-P
Caregivers are randomly assigned to one of two groups. The KEEP-P group completes a basic version of the curriculum. The intervention content is delivered by a KEEP-P group facilitator in a 2-hour weekly group format. Duration of the program is 12 weeks.
Behavioral: KEEP-P
The KEEP-P program is a low-cost, manualized, group-based intervention for caregivers of preschool aged children. This trial is evaluating 2 versions of the intervention. KEEP-P is a basic version that employs a curriculum of 12 weekly psychoeducational caregiver support groups Across four waves of data collection (baseline, postintervention, and 12 and 18 months postbaseline), we will examine the extent to which this intervention condition shows improved parenting, reduced rates of disrupted placements, and improved child outcomes.
Experimental: KEEP-P+
Caregivers are randomly assigned to one of two groups. The KEEP-P+ group completes an augmented version of the intervention with curriculum that includes the addition of information about recent findings in early brain development and a video coaching component based on the Filming Interactions to Nurture Development (FIND) program. The intervention content is delivered by a KEEP-P group facilitator in a 2-hour weekly group format. Duration of the program is 12 weeks.
Behavioral: KEEP-P+
The KEEP-P program is a low-cost, manualized, group-based intervention for caregivers of preschool aged children. This trial is evaluating 2 versions of the intervention. KEEP-P+ is an augmented version that consists of the caregiver support groups with extended curriculum including information about recent findings in early brain development and the elements of the Filming Interactions to Nurture Development video coaching program. Across four waves of data collection (baseline, postintervention, and 12 and 18 months postbaseline), we will examine the extent to which this intervention condition show improved parenting, reduced rates of disrupted placements, and improved child outcomes.

Detailed Description:

Randomized Trial of KEEP-P, a Preventive Intervention for Foster Preschoolers (KEEP-P).

Preschool-aged foster and other high-risk children are at increased risk for numerous negative outcomes. However, there is very limited use of evidence-based interventions for these young children. Major barriers to progress in this area include a lack of available evidence-based programs for high-risk children across the preschool years and the tendency for the few existing evidence-based interventions to be resource intensive in terms of funding and the level of staff expertise required to be implemented with fidelity. Readily scalable, evidence-based interventions for foster and other high-risk preschoolers are clearly needed to reduce the widespread disparities. The goal of the proposed study is to conduct a randomized clinical trial of a new, low-cost, manualized, group-based intervention for caregivers of preschool aged children. The investigators propose to evaluate two versions of the intervention: (a) a basic version that employs a curriculum consisting of 12 weekly psychoeducational caregiver support groups and (b) an augmented version that consists of the caregiver support groups with extended curriculum including with the addition of information about recent findings in early brain development and the elements of the Filming Interactions to Nurture Development (FIND) video coaching program. Across four waves of data collection (baseline, immediately postintervention, and 12 and 18 months postbaseline), the investigators will examine the extent to which the two intervention conditions show improved parenting, reduced rates of disrupted placements, and improved child outcomes. The investigators will conduct multivariate modeling to examine mediating mechanisms underlying the hypothesized immediate and longer- term intervention effects.

Finally, the investigators will conduct a comprehensive economic evaluation to examine the incremental costs associated with implementing the intervention and the benefits realized in the intervention conditions in terms of increased positive outcomes for children.

  Eligibility

Ages Eligible for Study:   30 Months to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Preschool-aged foster children

Exclusion Criteria:

  • Children will be excluded from recruitment if they or their primary caregiver are not sufficiently fluent in English to complete the assessment or if it is determined that the child would not be able to complete the assessment procedures due to a severe developmental, medical, or physical disorder.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03106636

Contacts
Contact: Kristen D Greenley, B.A. 541-346-8073 kdg@uoregon.edu
Contact: Alexander S Wagnon, B.S. 541-346-4747 shaffner@uoregon.edu

Locations
United States, Oregon
Prevention Science Institute Recruiting
Eugene, Oregon, United States, 97403
University of Oregon Recruiting
Eugene, Oregon, United States, 97403
Sponsors and Collaborators
University of Oregon
Oregon Social Learning Center
Investigators
Principal Investigator: Philip A Fisher, PhD University of Oregon
  More Information

Publications:
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Aos, S., Lieb, R., Mayfield, J., Miller, M., & Pennucci, A. (2004). Benefits and costs of prevention and early intervention programs for youth. Olympia, WA: Washington State Institute for Public Policy.
Price, J. M., Chamberlain, P., Landsverk, J., & Reid, J. (2009). KEEP foster-parent training intervention: Model description and effectiveness. Child and Family Social Work, 14, 233-242.
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Cullen, J. P., Ownbey, J. B., & Ownbey, M. A. (2010). The effects of the Healthy Families America home visitation program on parenting attitudes and practices and child social and emotional competence. Child and Adolescent Social Work Journal, 27, 335-354.
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Zima, B. T., Bussing, R., Freeman, S., Yang, X., Belin, T. R., & Forness, S. R. (2000). Behavior problems, academic skill delays and school failure among school-aged children in foster care: Their relationship to placement characteristics. Journal of Child and Family Studies, 9, 87-103.
Goerge, R. M., Van Voorhis, J., Grant, S., Casey, K., & Robinson, M. (1992). Special-education experiences of foster children: An empirical study. Child Welfare: Journal of Policy, Practice, and Program, 71, 419-437.
Smith, D. K., Stormshak, E., Chamberlain, P., & Whaley, R. B. (2001). Placement disruption in treatment foster care. Journal of Emotional and Behavioral Disorders, 9, 200-205.
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Dozier, M., & Rutter, M. (2008). Challenges to the development of attachment relationships faced by young children in foster and adoptive care. In J. Cassidy, P. R. Shaver (Eds.), Handbook of attachment: Theory, research, and clinical applications (2nd ed., pp. 698-717). New York, NY: Guilford Press.
Ward, H., & Holmes, L. (2008). Calculating the costs of local authority care for children with contrasting needs. Child and Family Social Work, 13, 80-90.
Fisher, P. A., Ellis, B. H., & Chamberlain, P. (1999). Early Intervention Foster Care: A model for preventing risk in young children who have been maltreated. Children's Services: Social Policy, Research, and Practice, 2, 159-182.
Dozier, M., Bick, J., & Bernard, K. (2011). Attachment-based treatment for young, vulnerable children. In J. D. Osofsky, A. F. Lieberman (Eds.), Clinical work with traumatized young children (pp. 75-95). New York, NY: Guilford Press.
Dozier, M., Higley, E., Albus, K. E., & Nutter, A. (2002). Intervening with foster infants' caregivers: Targeting three critical needs. Infant Mental Health Journal, 23, 541-554.
Dozier, M., Peloso, E., Lindhiem, O., Gordon, M. K., Manni, M., Sepulveda, S., … Levine, S. (2006). Developing evidence-based interventions for foster children: An example of a randomized clinical trial with infants and toddlers. Journal of Social Issues, 62, 767-785.
Byford, S., & Sefton, T. (2003). Economic evaluation of complex health and social care interventions. National Institute Economic Review, 186, 98-108.
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Lynch, F. L., Dickerson, J. F., Saldana, L., & Fisher, P. A. (2012). Incremental net benefit of early intervention for preschool-aged children with emotional and behavioral problems in foster care. Manuscript submitted for publication.
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Howse, R. B., Calkins, S. D., Anastopoulos, A. D., Keane, S. P., & Shelton, T. L. (2003). Regulatory contributors to children's kindergarten acheivement. Early Education and Development, 14, 101-119.
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Chamberlain, P. (1998). Treatment Foster Care. Family Strengthening Series (OJJDP Bulletin NCJ l734211). Washington, DC: U.S. Department of Justice.
Reid, J. B., & Eddy, J. M. (1997). The prevention of antisocial behavior: Some considerations in the search for effective interventions. In D. M. Stoff, J. Breiling, J. D. Maser (Eds.), Handbook of antisocial behavior (pp. 343-356). Hoboken, NJ: Wiley.
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Chamberlain, P., Davis, J. P., Buchanan, R., & Sprengelmeyer, P. (2010). Facilitator Adherence Ratings Unpublished instrument available from Oregon Social Learning Center.
Healey, C. V., Bronz, K. D., Fisher, P. A., & Pears, K. C. (2010). KEEP-P Playgroup Implementation Fidelity Checklist. Unpublished instrument available from Oregon Social Learning Center.
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Responsible Party: Phil Fisher, PhD, University of Oregon
ClinicalTrials.gov Identifier: NCT03106636     History of Changes
Other Study ID Numbers: 06112013.016
Study First Received: June 4, 2015
Last Updated: April 14, 2017
Individual Participant Data  
Plan to Share IPD: Undecided
Plan Description: De-identified IPD data will be shared with other researchers upon completion of the data set as well as completion of a data sharing agreement.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Phil Fisher, University of Oregon:
Preschool-aged
Foster children
child welfare
Fostercare
Parent training
early adversity
curriculum based
early intervention
preschool
foster placement disruptions
manualized intervention
group based intervention
high-risk children

ClinicalTrials.gov processed this record on May 25, 2017