Promoting Infant Mental Health in Foster Care
2 other identifiers
interventional
236
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2007
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 19, 2006
CompletedFirst Posted
Study publicly available on registry
June 21, 2006
CompletedStudy Start
First participant enrolled
April 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2011
CompletedMay 17, 2012
May 1, 2012
3.8 years
June 19, 2006
May 16, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Toddler Attachment Sort-45
Measured at Months 1, 6, and 12 post-treatment
Nursing Child Assessment Satellite Training (NCAST) Teaching Scale
Measured at Months 1, 6, and 12 post-treatment
Indicator of Parent-Child Interaction (IPCI)
Measured at Months 1, 6, and 12 post-treatment
Brief Infant-Toddler Social Emotional Assessment
Measured at Months 1, 6, and 12 post-treatment
Bayley Scales of Infant Development, 3rd Edition Screening Test
Measured at baseline and Month 6 post-treatment
Secondary Outcomes (2)
Parenting Stress Index/Short Form
Measured at Months 1, 6, and 12 post-treatment
Patient Health Questionnaire (PHQ-9)
Measured at Months 1, 6, and 12 post-treatment
Study Arms (2)
1
EXPERIMENTALPromoting first relationships group
2
ACTIVE COMPARATOREarly education support group
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Foster care provider is not English-speaking
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Washington
Seattle, Washington, 98195-7920, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Susan J. Spieker, PhD
University of Washington
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 19, 2006
First Posted
June 21, 2006
Study Start
April 1, 2007
Primary Completion
January 1, 2011
Study Completion
July 1, 2011
Last Updated
May 17, 2012
Record last verified: 2012-05