Promoting Infant Mental Health in Foster Care
Primary Purpose
Child Development, Child Behavior Disorders, Reactive Attachment Disorder
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Promoting First Relationships Program
Early Education Support Program
Sponsored by
About this trial
This is an interventional prevention trial for Child Development focused on measuring Infants, Toddlers, Attachment, Maltreatment, Foster Care
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
Sites / Locations
- University of Washington
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Promoting first relationships group
Early education support group
Outcomes
Primary Outcome Measures
Toddler Attachment Sort-45
Nursing Child Assessment Satellite Training (NCAST) Teaching Scale
Indicator of Parent-Child Interaction (IPCI)
Brief Infant-Toddler Social Emotional Assessment
Bayley Scales of Infant Development, 3rd Edition Screening Test
Secondary Outcome Measures
Parenting Stress Index/Short Form
Patient Health Questionnaire (PHQ-9)
Full Information
NCT ID
NCT00339365
First Posted
June 19, 2006
Last Updated
May 16, 2012
Sponsor
University of Washington
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT00339365
Brief Title
Promoting Infant Mental Health in Foster Care
Official Title
Promoting Infant Mental Health in Foster Care
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
July 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Washington
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Child Development, Child Behavior Disorders, Reactive Attachment Disorder
Keywords
Infants, Toddlers, Attachment, Maltreatment, Foster Care
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
236 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Promoting first relationships group
Arm Title
2
Arm Type
Active Comparator
Arm Description
Early education support group
Intervention Type
Behavioral
Intervention Name(s)
Promoting First Relationships Program
Other Intervention Name(s)
PFR
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Early Education Support Program
Other Intervention Name(s)
EES
Intervention Description
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.
Primary Outcome Measure Information:
Title
Toddler Attachment Sort-45
Time Frame
Measured at Months 1, 6, and 12 post-treatment
Title
Nursing Child Assessment Satellite Training (NCAST) Teaching Scale
Time Frame
Measured at Months 1, 6, and 12 post-treatment
Title
Indicator of Parent-Child Interaction (IPCI)
Time Frame
Measured at Months 1, 6, and 12 post-treatment
Title
Brief Infant-Toddler Social Emotional Assessment
Time Frame
Measured at Months 1, 6, and 12 post-treatment
Title
Bayley Scales of Infant Development, 3rd Edition Screening Test
Time Frame
Measured at baseline and Month 6 post-treatment
Secondary Outcome Measure Information:
Title
Parenting Stress Index/Short Form
Time Frame
Measured at Months 1, 6, and 12 post-treatment
Title
Patient Health Questionnaire (PHQ-9)
Time Frame
Measured at Months 1, 6, and 12 post-treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Months
Maximum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan J. Spieker, PhD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195-7920
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Promoting Infant Mental Health in Foster Care
We'll reach out to this number within 24 hrs