Promoting Infant Mental Health in Foster Care

May 16, 2012 updated by: University of Washington
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

236

Phase

  • Phase 2
  • Phase 3

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

  • United States
    • Washington
      • Seattle, Washington, United States, 98195-7920
        • University of Washington

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

10 months to 2 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

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
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 Names:
  • 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 Names:
  • EES

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Toddler Attachment Sort-45
Time Frame: Measured at Months 1, 6, and 12 post-treatment
Measured at Months 1, 6, and 12 post-treatment
Nursing Child Assessment Satellite Training (NCAST) Teaching Scale
Time Frame: Measured at Months 1, 6, and 12 post-treatment
Measured at Months 1, 6, and 12 post-treatment
Indicator of Parent-Child Interaction (IPCI)
Time Frame: Measured at Months 1, 6, and 12 post-treatment
Measured at Months 1, 6, and 12 post-treatment
Brief Infant-Toddler Social Emotional Assessment
Time Frame: Measured at Months 1, 6, and 12 post-treatment
Measured at Months 1, 6, and 12 post-treatment
Bayley Scales of Infant Development, 3rd Edition Screening Test
Time Frame: Measured at baseline and Month 6 post-treatment
Measured at baseline and Month 6 post-treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Parenting Stress Index/Short Form
Time Frame: Measured at Months 1, 6, and 12 post-treatment
Measured at Months 1, 6, and 12 post-treatment
Patient Health Questionnaire (PHQ-9)
Time Frame: Measured at Months 1, 6, and 12 post-treatment
Measured at Months 1, 6, and 12 post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Susan J. Spieker, PhD, University of Washington

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

April 1, 2007

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

June 19, 2006

First Submitted That Met QC Criteria

June 19, 2006

First Posted (Estimate)

June 21, 2006

Study Record Updates

Last Update Posted (Estimate)

May 17, 2012

Last Update Submitted That Met QC Criteria

May 16, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01MH077329 (U.S. NIH Grant/Contract)
  • DSIR 84-CTS (Division of Services and Intervention Research)

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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