Clinical trial NCT00816621: Effectiveness of a Parent Training Program for Parents of Children Adopted Internationally
Official title: Early Intervention for Children Adopted Internationally
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Attachment Disorders
Keywords: Internationally Adopted Children
Adoption
Attachment
Inattention
Prevention
Lead sponsor: University of Delaware
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2009-01-01
Enrollment: 220
Sex: ALL
Minimum age (years): 12
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* Adopted a child internationally

Exclusion Criteria:

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

Primary outcomes:
measure: Inattention
timeFrame: Measured pre-intervention, post-intervention, and when the child turns 2, 3, and 4
Secondary outcomes:
measure: Cortisol production
timeFrame: Measured pre-intervention, post-intervention, and when the child turns 2, 3, and 4
measure: Competence
timeFrame: Measured post-intervention at ages 3 and 4
measure: Problem behaviors
timeFrame: Measured post-intervention at ages 3 and 4
measure: Attachment
timeFrame: Measured post-intervention at age 2-4
measure: Executive functioning
timeFrame: Measured at ages 3 and 4
measure: Emotion regulation
timeFrame: Measured at ages 3 and 4
measure: Problem behaviors
timeFrame: Ages 3 and 4
measure: Executive functioning
timeFrame: Ages 3 and 4
Other outcomes:
Locations:
city: Newark
country: United States
facility: University of Delaware
state: Delaware
Study officials:
affiliation: University of Delaware
name: Mary Dozier, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yarger HA, Lind T, Raby KL, Zajac L, Wallin A, Dozier M. Intervening With Attachment and Biobehavioral Catch-Up to Reduce Behavior Problems Among Children Adopted Internationally: Evidence From a Randomized Controlled Trial. Child Maltreat. 2022 Aug;27(3):478-489. doi: 10.1177/10775595211010975. Epub 2021 Apr 22.
citation: Lind T, Lee Raby K, Goldstein A, Bernard K, Caron EB, Yarger HA, Wallin A, Dozier M. Improving social-emotional competence in internationally adopted children with the Attachment and Biobehavioral Catch-up intervention. Dev Psychopathol. 2021 Aug;33(3):957-969. doi: 10.1017/S0954579420000255.
citation: Yarger HA, Bernard K, Caron EB, Wallin A, Dozier M. Enhancing Parenting Quality for Young Children Adopted Internationally: Results of a Randomized Controlled Trial. J Clin Child Adolesc Psychol. 2020 May-Jun;49(3):378-390. doi: 10.1080/15374416.2018.1547972. Epub 2019 Jan 16.