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Effectiveness of a Parent Training Program for Parents of Children Adopted Internationally
This study is currently recruiting participants.
Verified by National Institute of Mental Health (NIMH), May 2009
First Received: December 30, 2008   Last Updated: May 11, 2009   History of Changes
Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00816621
  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: Attachment and Biobehavioral Catch-up for Children Adopted Internationally
Behavioral: Developmental Education for Families

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

Further study details as provided by National Institute of Mental Health (NIMH):

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 ]

Estimated Enrollment: 220
Study Start Date: January 2009
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
ABC-I: Experimental Behavioral: Attachment and Biobehavioral Catch-up for Children Adopted Internationally
Participants will attend 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.
DEF: Active Comparator Behavioral: Developmental Education for Families
Participants will attend 10 weekly in-home intervention sessions aimed at enhancing the intellectual and language development of children.

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 30 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

Contacts
Contact: Mary Dozier, PhD 302-831-2286 mdozier@udel.edu

Locations
United States, Delaware
University of Delaware Recruiting
Newark, Delaware, United States, 19716
Contact: Mary Dozier     302-831-2286     mdozier@udel.edu    
Sponsors and Collaborators
Investigators
Principal Investigator: Mary Dozier, PhD University of Delaware
  More Information

Additional Information:
No publications provided

Responsible Party: University of Delaware ( Mary Dozier, Principal Investigator )
Study ID Numbers: R01 MH084135, DSIR 84-CTP
Study First Received: December 30, 2008
Last Updated: May 11, 2009
ClinicalTrials.gov Identifier: NCT00816621     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
Internationally Adopted Children
Adoption
Attachment
Inattention
Prevention

ClinicalTrials.gov processed this record on September 02, 2009