跳至主要内容
临床试验/NCT00339365
NCT00339365已完成2 期

Promoting Infant Mental Health in Foster Care

University of Washington2 个研究点 分布在 1 个国家目标入组 236 人开始时间: 2007年4月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
236
试验地点
2
主要终点
Indicator of Parent-Child Interaction (IPCI)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
10 Months 至 24 Months(Child)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Foster care provider is not English-speaking

结局指标

主要结局

Indicator of Parent-Child Interaction (IPCI)

时间窗: Measured at Months 1, 6, and 12 post-treatment

Toddler Attachment Sort-45

时间窗: Measured at Months 1, 6, and 12 post-treatment

Nursing Child Assessment Satellite Training (NCAST) Teaching Scale

时间窗: Measured at Months 1, 6, and 12 post-treatment

Brief Infant-Toddler Social Emotional Assessment

时间窗: Measured at Months 1, 6, and 12 post-treatment

Bayley Scales of Infant Development, 3rd Edition Screening Test

时间窗: Measured at baseline and Month 6 post-treatment

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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