Promoting Infant Mental Health in Foster Care
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|ClinicalTrials.gov Identifier: NCT00339365|
Recruitment Status : Completed
First Posted : June 21, 2006
Last Update Posted : May 17, 2012
|Condition or disease||Intervention/treatment||Phase|
|Child Development Child Behavior Disorders Reactive Attachment Disorder||Behavioral: Promoting First Relationships Program Behavioral: Early Education Support Program||Phase 2 Phase 3|
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 (Clinical Trial)|
|Actual Enrollment :||236 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Promoting Infant Mental Health in Foster Care|
|Study Start Date :||April 2007|
|Primary Completion Date :||January 2011|
|Study Completion Date :||July 2011|
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
- Toddler Attachment Sort-45 [ Time Frame: 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 ]
- Indicator of Parent-Child Interaction (IPCI) [ Time Frame: 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 ]
- Bayley Scales of Infant Development, 3rd Edition Screening Test [ Time Frame: Measured at baseline and Month 6 post-treatment ]
- Parenting Stress Index/Short Form [ Time Frame: 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00339365
|United States, Washington|
|University of Washington|
|Seattle, Washington, United States, 98195-7920|
|Principal Investigator:||Susan J. Spieker, PhD||University of Washington|