Effectiveness of a Parent Training Program for Parents of Children Adopted Internationally

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Mary Dozier, University of Delaware
ClinicalTrials.gov Identifier:
NCT00816621
First received: December 30, 2008
Last updated: November 1, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Attachment Disorders
Behavioral: ABC for Children Adopted Internationally
Behavioral: DEF for Children Adopted Internationally

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Early Intervention for Children Adopted Internationally

Further study details as provided by University of Delaware:

Primary Outcome Measures:
  • Inattention [ Time Frame: Measured pre-intervention, post-intervention, and when the child turns 2, 3, and 4 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cortisol production [ Time Frame: Measured pre-intervention, post-intervention, and when the child turns 2, 3, and 4 ] [ Designated as safety issue: No ]

Enrollment: 220
Study Start Date: January 2009
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ABC for Children Adopted Internationally
ABC for Children Adopted Internationally: 10 session in home intervention that targets parent nurturance, synchrony, pseudo-autistic behaviors, and indiscriminate sociability
Behavioral: ABC for Children Adopted Internationally
Participants will participate in 10 weekly in-home intervention sessions aimed at enhancing the ability of children to regulate their attention, behavior, and physiology and to develop secure, organized attachments to their parents.
Other Names:
  • Attachment and Biobehavioral Catch-up
  • ABC
  • ABC-I
Active Comparator: DEF for Children Adopted Internationally
DEF for Children Adopted Internationally: 10 session in home intervention that targets cognitive and motor delays
Behavioral: DEF for Children Adopted Internationally
Participants will participate in 10 weekly in-home intervention sessions aimed at enhancing the intellectual and language development of children.
Other Names:
  • DEF
  • PT/OT
  • Physical Therapy/Occupational Therapy

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.

  Eligibility

Ages Eligible for Study:   12 Months to 36 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adopted a child internationally

Exclusion Criteria:

  • Child has known serious medical condition, such as cerebral palsy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00816621

Locations
United States, Delaware
University of Delaware
Newark, Delaware, United States, 19716
Sponsors and Collaborators
University of Delaware
Investigators
Principal Investigator: Mary Dozier, PhD University of Delaware
  More Information

Additional Information:
No publications provided

Responsible Party: Mary Dozier, Principal Investigator, University of Delaware
ClinicalTrials.gov Identifier: NCT00816621     History of Changes
Other Study ID Numbers: R01 MH084135, R01MH084135, DSIR 84-CTP
Study First Received: December 30, 2008
Last Updated: November 1, 2013
Health Authority: United States: Federal Government

Keywords provided by University of Delaware:
Internationally Adopted Children
Adoption
Attachment
Inattention
Prevention

ClinicalTrials.gov processed this record on April 15, 2014