Clinical trial NCT00339365: Promoting Infant Mental Health in Foster Care
Official title: Promoting Infant Mental Health in Foster Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Child Development
Child Behavior Disorders
Reactive Attachment Disorder
Keywords: Infants
Toddlers
Attachment
Maltreatment
Foster Care
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2006-06-21
Enrollment: 236
Sex: ALL
Minimum age (years): 10
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Toddler Attachment Sort-45
timeFrame: Measured at Months 1, 6, and 12 post-treatment
measure: Nursing Child Assessment Satellite Training (NCAST) Teaching Scale
timeFrame: Measured at Months 1, 6, and 12 post-treatment
measure: Indicator of Parent-Child Interaction (IPCI)
timeFrame: Measured at Months 1, 6, and 12 post-treatment
measure: Brief Infant-Toddler Social Emotional Assessment
timeFrame: Measured at Months 1, 6, and 12 post-treatment
measure: Bayley Scales of Infant Development, 3rd Edition Screening Test
timeFrame: Measured at baseline and Month 6 post-treatment
Secondary outcomes:
measure: Parenting Stress Index/Short Form
timeFrame: Measured at Months 1, 6, and 12 post-treatment
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: Measured at Months 1, 6, and 12 post-treatment
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Susan J. Spieker, PhD
role: PRINCIPAL_INVESTIGATOR
References: