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Promoting Infant Mental Health in Foster Care

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Washington
ClinicalTrials.gov Identifier:
NCT00339365
First received: June 19, 2006
Last updated: May 16, 2012
Last verified: May 2012
  Purpose

This study will evaluate the effectiveness of the Promoting First Relationships (PFR) program versus an Early Education Support (EES) program in promoting infant well-being, preventing emotional and behavioral problems, countering developmental delay, and reducing placement instability in young foster care children.


Condition Intervention Phase
Child Development
Child Behavior Disorders
Reactive Attachment Disorder
Behavioral: Promoting First Relationships Program
Behavioral: Early Education Support Program
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Promoting Infant Mental Health in Foster Care

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Toddler Attachment Sort-45 [ Time Frame: Measured at Months 1, 6, and 12 post-treatment ] [ Designated as safety issue: No ]
  • Nursing Child Assessment Satellite Training (NCAST) Teaching Scale [ Time Frame: Measured at Months 1, 6, and 12 post-treatment ] [ Designated as safety issue: No ]
  • Indicator of Parent-Child Interaction (IPCI) [ Time Frame: Measured at Months 1, 6, and 12 post-treatment ] [ Designated as safety issue: No ]
  • Brief Infant-Toddler Social Emotional Assessment [ Time Frame: Measured at Months 1, 6, and 12 post-treatment ] [ Designated as safety issue: No ]
  • Bayley Scales of Infant Development, 3rd Edition Screening Test [ Time Frame: Measured at baseline and Month 6 post-treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Parenting Stress Index/Short Form [ Time Frame: Measured at Months 1, 6, and 12 post-treatment ] [ Designated as safety issue: No ]
  • Patient Health Questionnaire (PHQ-9) [ Time Frame: Measured at Months 1, 6, and 12 post-treatment ] [ Designated as safety issue: No ]

Enrollment: 236
Study Start Date: April 2007
Study Completion Date: July 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Promoting first relationships group
Behavioral: Promoting First Relationships Program
Participants assigned to PFR will receive ten weekly home visits that will focus on promoting the development of a secure attachment between foster parents and infants.
Other Name: PFR
Active Comparator: 2
Early education support group
Behavioral: Early Education Support Program
EES will consist of three monthly home visits, during which infants will be assessed and referred for additional care if necessary. EES participants will not receive any training.
Other Name: EES

Detailed Description:

Infants who enter foster care are at risk for developing multiple social and emotional problems later in life. These behavioral issues often result in foster children being placed with multiple different families during their childhoods. In turn, an unstable family life can lead to serious conduct disorders and mental health problems. The infants' loss of their first attachment relationship heightens the risks for developing these problems, even if the quality of care was poor prior to removal. Infants' reactions to this loss, combined with other vulnerabilities, complicate the development of new secure attachments to their foster care families. Garnering a secure attachment relationship between foster parents and foster infants may reduce the infant's risk for developing problematic mental health and conduct issues. PFR is a family therapy intervention focused on aiding foster care parents to cultivate secure attachments with their foster infants. This study will evaluate the effectiveness of the PFR program versus an EES program in promoting attachment security and infant well-being, preventing emotional and behavioral problems, countering developmental delay, and reducing placement instability in young foster care children.

Participants in this single-blind study will be randomly assigned to receive either PFR or EES. Both interventions will be administered by a trained staff member of a community agency. Participants assigned to PFR will receive ten weekly home visits that will focus on promoting the development of a secure attachment between foster parents and infants. EES will consist of three monthly home visits, during which infants will be assessed and referred for additional care if necessary. EES participants will not receive any training. Outcomes will be assessed at 1, 6, and 12 months post-intervention for all participants.

  Eligibility

Ages Eligible for Study:   10 Months to 24 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Transitioned into foster care, currently within foster care, or from foster care in past three months prior to study entry in Pierce County, WA
  • Primary caregiver is foster care provider, kin caregiver, or biological parent

Exclusion Criteria:

  • Foster care provider is not English-speaking
  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: NCT00339365

Locations
United States, Washington
University of Washington
Seattle, Washington, United States, 98195-7920
Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: Susan J. Spieker, PhD University of Washington
  More Information

No publications provided

Responsible Party: University of Washington
ClinicalTrials.gov Identifier: NCT00339365     History of Changes
Other Study ID Numbers: R01 MH077329, R01MH077329, DSIR 84-CTS
Study First Received: June 19, 2006
Last Updated: May 16, 2012
Health Authority: United States: Federal Government

Keywords provided by University of Washington:
Infants
Toddlers
Attachment
Maltreatment
Foster Care

Additional relevant MeSH terms:
Child Behavior Disorders
Disease
Reactive Attachment Disorder
Mental Disorders
Mental Disorders Diagnosed in Childhood
Pathologic Processes

ClinicalTrials.gov processed this record on November 25, 2014