A Phase 2/3 interventional study of Promoting First Relationships Program and Early Education Support Program in Child Development, Child Behavior Disorders and Reactive Attachment Disorder, sponsored by University of Washington. Completed at 1 site in United States. Open to participants aged 10 Months to 24 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-05-17.
Sponsored by University of Washington · Phase 2/3, Interventional, and Prevention
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.
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.
35 studies on the registry are indexed under Child Behavior Disorders; 10 are open to participants now.
This study's enrollment of 236 is above the median of 134 across 25 interventional studies indexed under Child Behavior Disorders.
Browse Child Behavior Disorders studies →University of Washington is the lead sponsor of 1,433 studies on the registry; 225 are open to participants now.
Of its 158 completed or terminated interventional studies of FDA-regulated products, 136 (86%) have results posted.
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Promoting first relationships group
Behavioral: Promoting First Relationships Program
Early education support group
Behavioral: Early Education Support 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.
Also known as: PFR
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.
Also known as: 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
This study is completed, as verified in May 2012. You cannot join it, but the record below documents what was studied.
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