| June 19, 2006 |
| March 9, 2009 |
| April 2007 |
| January 2011 (final data collection date for primary outcome measure) |
- Toddler Attachment Sort-45 [ Time Frame: Measured at Months 1, 6, and 12 post-treatment ] [ Designated as safety issue: No ]
- Nursing Child Assessment Satellite Training (NCAST) Teaching Scale [ Time Frame: Measured at Months 1, 6, and 12 post-treatment ] [ Designated as safety issue: No ]
- Indicator of Parent-Child Interaction (IPCI) [ Time Frame: Measured at Months 1, 6, and 12 post-treatment ] [ Designated as safety issue: No ]
- Brief Infant-Toddler Social Emotional Assessment [ Time Frame: Measured at Months 1, 6, and 12 post-treatment ] [ Designated as safety issue: No ]
- Bayley Scales of Infant Development, 3rd Edition Screening Test [ Time Frame: Measured at baseline and Month 6 post-treatment ] [ Designated as safety issue: No ]
|
- Measured at 1, 6, and 12 months post-intervention: Toddler Attachment Sort-45
- Nursing Child Assessment Satellite Training (NCAST) Teaching Scale
- Child problem solving tasks
- Brief Infant-Toddler Social Emotional Assessment
- Measured at 12 months post-intervention: Bayley Scales of Infant Development, 3rd Edition Screening Test
- Preschool Age Psychiatric Assessment
- Functional Emotional Assessment Scale
- Child inhibitory control: Delay of Gratification Task
|
| Complete list of historical versions of study NCT00339365 on ClinicalTrials.gov Archive Site |
- Parenting Stress Index/Short Form [ Time Frame: Measured at Months 1, 6, and 12 post-treatment ] [ Designated as safety issue: No ]
- Patient Health Questionnaire (PHQ-9) [ Time Frame: Measured at Months 1, 6, and 12 post-treatment ] [ Designated as safety issue: No ]
|
- Measured at 1, 6, and 12 months post-intervention: Parenting Stress Index/Short Form
- Edinburgh Postnatal Depression Screener
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| |
| Promoting Infant Mental Health in Foster Care |
| Promoting Infant Mental Health in Foster Care |
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. |
| Phase II, Phase III |
| Interventional |
| Prevention, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Efficacy Study |
- Child Development
- Child Behavior Disorders
- Reactive Attachment Disorder
|
- Behavioral: Promoting First Relationships Program
- Behavioral: Early Education Support Program
|
- Experimental: Promoting first relationships group
- Active Comparator: Early education support group
|
| |
| |
| Recruiting |
| 236 |
| July 2011 |
| January 2011 (final data collection date for primary outcome measure) |
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
|
| Both |
| 10 Months to 24 Months |
| Yes |
|
|
| United States |
| |
| NCT00339365 |
| Amy B. Goldstein, PhD, Chief, Child & Adolescent Prevention Intervention Program, NIMH |
| R01 MH077329, DSIR 84-CTS |
| National Institute of Mental Health (NIMH) |
|
| Principal Investigator: |
Susan J. Spieker, PhD |
University of Washington |
|
|
| National Institute of Mental Health (NIMH) |
| March 2009 |