Effectiveness of a Parent Training Program for Parents of Children Adopted Internationally
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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: | 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 |
- Inattention [ Time Frame: Measured pre-intervention, post-intervention, and when the child turns 2, 3, and 4 ] [ Designated as safety issue: No ]
- 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 |
|---|---|
| Experimental: ABC-I |
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.
|
| Active Comparator: DEF |
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 |
Inclusion Criteria:
- Adopted a child internationally
Exclusion Criteria:
- Child has known serious medical condition, such as cerebral palsy
Contacts and Locations| Contact: Mary Dozier, PhD | 302-831-2286 | mdozier@udel.edu |
| United States, Delaware | |
| University of Delaware | Recruiting |
| Newark, Delaware, United States, 19716 | |
| Contact: Mary Dozier 302-831-2286 mdozier@udel.edu | |
| 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, DSIR 84-CTP |
| Study First Received: | December 30, 2008 |
| Last Updated: | May 11, 2009 |
| 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 May 16, 2013