Effectiveness of a Parent Training Program for Parents of Children Adopted Internationally
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|ClinicalTrials.gov Identifier: NCT00816621|
Recruitment Status : Active, not recruiting
First Posted : January 1, 2009
Last Update Posted : December 20, 2016
|Condition or disease||Intervention/treatment||Phase|
|Attachment Disorders||Behavioral: ABC for Children Adopted Internationally Behavioral: DEF for Children Adopted Internationally||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||220 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Early Intervention for Children Adopted Internationally|
|Study Start Date :||January 2009|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2017|
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.
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.
- Inattention [ Time Frame: Measured pre-intervention, post-intervention, and when the child turns 2, 3, and 4 ]
- Cortisol production [ Time Frame: Measured pre-intervention, post-intervention, and when the child turns 2, 3, and 4 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00816621
|United States, Delaware|
|University of Delaware|
|Newark, Delaware, United States, 19716|
|Principal Investigator:||Mary Dozier, PhD||University of Delaware|