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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00339365 |
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 |
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Child Development Child Behavior Disorders Reactive Attachment Disorder |
Behavioral: Promoting First Relationships Program Behavioral: Early Education Support Program |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Promoting Infant Mental Health in Foster Care |
Estimated Enrollment: | 236 |
Study Start Date: | April 2007 |
Estimated Study Completion Date: | July 2011 |
Estimated Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Promoting first relationships group
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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.
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2: Active Comparator
Early education support group
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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.
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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.
Ages Eligible for Study: | 10 Months to 20 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Susan J. Spieker, PhD | 206-543-8453 | spieker@u.washington.edu |
Contact: Maureen Marcenko, PhD | 206-543-3546 | mmarcenk@u.washington.edu |
United States, Washington | |
University of Washington | Recruiting |
Seattle, Washington, United States, 98195-7920 |
Principal Investigator: | Susan J. Spieker, PhD | University of Washington |
Responsible Party: | NIMH ( Amy B. Goldstein, PhD, Chief, Child & Adolescent Prevention Intervention Program ) |
Study ID Numbers: | R01 MH77329, DSIR 84-CTS |
Study First Received: | June 19, 2006 |
Last Updated: | August 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00339365 |
Health Authority: | United States: Federal Government |
Infants Toddlers Attachment Maltreatment Foster Care |
Reactive Attachment Disorder Child Behavior Disorders Mental Disorders Mental Disorders Diagnosed in Childhood |
Pathologic Processes Disease |