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Clinical Trials/NCT00816621
NCT00816621
Completed
N/A

Early Intervention for Children Adopted Internationally

University of Delaware1 site in 1 country220 target enrollmentJanuary 2009

Overview

Phase
N/A
Intervention
Not specified
Conditions
Attachment Disorders
Sponsor
University of Delaware
Enrollment
220
Locations
1
Primary Endpoint
Inattention
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
January 2009
End Date
March 20, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mary Dozier

Principal Investigator

University of Delaware

Eligibility Criteria

Inclusion Criteria

  • Adopted a child internationally

Exclusion Criteria

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

Outcomes

Primary Outcomes

Inattention

Time Frame: Measured pre-intervention, post-intervention, and when the child turns 2, 3, and 4

Secondary Outcomes

  • 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)

Study Sites (1)

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