Promoting Infant Mental Health in Foster Care

Sponsor

University of Washington (Other)

Overall Status

Completed

CT.gov ID

NCT00339365

Collaborator

National Institute of Mental Health (NIMH) (NIH)

236

Enrollment

Location

Arms

Duration (Months)

4.6

Patients Per Site Per Month

Study Details

Study Description

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.

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

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

236 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Prevention

Official Title:

Promoting Infant Mental Health in Foster Care

Study Start Date :

Apr 1, 2007

Actual Primary Completion Date :

Jan 1, 2011

Actual Study Completion Date :

Jul 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 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 Names: 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 Names: EES

Arm

Intervention/Treatment

Experimental: 1

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 Names:

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 Names:

EES

Outcome Measures

Primary Outcome Measures

Toddler Attachment Sort-45 [Measured at Months 1, 6, and 12 post-treatment]
Nursing Child Assessment Satellite Training (NCAST) Teaching Scale [Measured at Months 1, 6, and 12 post-treatment]
Indicator of Parent-Child Interaction (IPCI) [Measured at Months 1, 6, and 12 post-treatment]
Brief Infant-Toddler Social Emotional Assessment [Measured at Months 1, 6, and 12 post-treatment]
Bayley Scales of Infant Development, 3rd Edition Screening Test [Measured at baseline and Month 6 post-treatment]

Secondary Outcome Measures

Parenting Stress Index/Short Form [Measured at Months 1, 6, and 12 post-treatment]
Patient Health Questionnaire (PHQ-9) [Measured at Months 1, 6, and 12 post-treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:

10 Months to 24 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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