Promoting Infant Mental Health in Foster Care

Child Development Clinical Trial

Official title:

Promoting Infant Mental Health in Foster Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00339365
• Other study ID #: R01MH077329
• Secondary ID: R01MH077329DSIR
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: June 19, 2006
• Last updated: May 16, 2012
• Start date: April 2007
• Est. completion date: July 2011

Study information

• Verified date: May 2012
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 236
• Est. completion date: July 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 10 Months to 24 Months

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Child Behavior Disorders
• Child Development
• Disease
• Reactive Attachment Disorder

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Washington	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Toddler Attachment Sort-45		Measured at Months 1, 6, and 12 post-treatment	No
Primary	Nursing Child Assessment Satellite Training (NCAST) Teaching Scale		Measured at Months 1, 6, and 12 post-treatment	No
Primary	Indicator of Parent-Child Interaction (IPCI)		Measured at Months 1, 6, and 12 post-treatment	No
Primary	Brief Infant-Toddler Social Emotional Assessment		Measured at Months 1, 6, and 12 post-treatment	No
Primary	Bayley Scales of Infant Development, 3rd Edition Screening Test		Measured at baseline and Month 6 post-treatment	No
Secondary	Parenting Stress Index/Short Form		Measured at Months 1, 6, and 12 post-treatment	No
Secondary	Patient Health Questionnaire (PHQ-9)		Measured at Months 1, 6, and 12 post-treatment	No