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临床试验/NCT00816621
NCT00816621已完成不适用

Early Intervention for Children Adopted Internationally

University of Delaware2 个研究点 分布在 1 个国家目标入组 220 人开始时间: 2009年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
220
试验地点
2
主要终点
Inattention

研究概览

简要总结

This study will test the effectiveness of a parent training program aimed at helping children who are adopted internationally to develop secure, organized attachments to their parents.

详细描述

Children adopted internationally by parents in the United States often experience institutional care prior to adoption. Early institutional care may lead to inattention, deficits in inhibitory control, and insecure attachments in children. Many of these problems persist even after the child is adopted. This study will test the effectiveness of a parent training program called Attachment and Biobehavioral Catch-up for Children Adopted Internationally (ABC-I). This program is designed to enhance children's ability to regulate their attention, behavior, and physiology and to develop secure, organized attachments to their parents.

Participation in this study will begin when the child participant is between 12 and 20 months old, and it will end when the child is 4 years old. Participants, who will include parents and their adopted child, will meet with the study researchers 3 times before receiving the training program intervention, twice in their home and once at the research site. During these visits, the background and medical history of the child participant will be reviewed. Participants will then be randomly assigned to receive 1 of 2 parent training programs: ABC-I or Developmental Education for Families (DEF). Both programs will involve 10 weekly sessions, each lasting 60 to 90 minutes and occurring in the parents' homes. The DEF training program will focus on enhancing the intellectual and language development of the child participant, but it will not train parents to pay attention to and interpret their children's cues. The ABC-I training program will involve videotaping parents while they interact with their children, reviewing the videotapes, discussing strategies for interacting with children, and completing homework assignments.

Participants will undergo assessments before and after the training programs and at follow-up visits when each child turns 2, 3, and 4 years old. Assessments will be made of sensitivity in parents and of inattention, inhibitory control, attachment quality, and cortisol production in children. Parent sensitivity will be measured by observing parent-child interactions and coding them according to a pre-existing scale. Child inattention and inhibitory control will be measured through observing each child's behaviors on various structured tasks, such as watching a video with a distracter present or being told to wait to open a wrapped gift. Attachment will be measured through observation of child behavior and through parent ratings and diaries. Cortisol production will be measured through a saliva sample, collected via cotton swab. When children are 4 years old, they will also be evaluated for diagnosable behavioral disorders. For a subset of children, cheek swabs will be collected at age 5-6 for the assessment of telomere length.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
12 Months 至 36 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Adopted a child internationally

排除标准

  • Child has known serious medical condition, such as cerebral palsy

结局指标

主要结局

Inattention

时间窗: Measured pre-intervention, post-intervention, and when the child turns 2, 3, and 4

次要结局

  • Cortisol production(Measured pre-intervention, post-intervention, and when the child turns 2, 3, and 4)
  • Competence(Measured post-intervention at ages 3 and 4)
  • Problem behaviors(Ages 3 and 4)
  • Attachment(Measured post-intervention at age 2-4)
  • Executive functioning(Ages 3 and 4)
  • Emotion regulation(Measured at ages 3 and 4)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mary Dozier

Principal Investigator

University of Delaware

研究点 (2)

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