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

Study Overview
=================
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.

Official Title
-----------------
Early Intervention for Children Adopted Internationally

Conditions
-----------------
Attachment Disorders

Intervention / Treatment
-----------------
* Behavioral: ABC for Children Adopted Internationally
* Behavioral: DEF for Children Adopted Internationally


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adopted a child internationally Exclusion Criteria: Child has known serious medical condition, such as cerebral palsy

Ages Eligible for Study
-----------------
Minimum Age: 12 Months
Maximum Age: 36 Months

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ABC for Children Adopted Internationally<br>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<br>* 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.<br>* Other names: ABC-I;|
| Active Comparator: DEF for Children Adopted Internationally<br>DEF for Children Adopted Internationally: 10 session in home intervention that targets cognitive and motor delays | Behavioral: DEF for Children Adopted Internationally<br>* Participants will participate in 10 weekly in-home intervention sessions aimed at enhancing the intellectual and language development of children.<br>* Other names: Physical Therapy/Occupational Therapy;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inattention |  | Measured pre-intervention, post-intervention, and when the child turns 2, 3, and 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cortisol production | Salivary cortisol measured at wake-up and bedtime. Eliza assay will be used. | Measured pre-intervention, post-intervention, and when the child turns 2, 3, and 4 | 
| Competence | Observational protocol from Disruptive Behaviors-Diagnostic Observation Scale (DB-DOS) | Measured post-intervention at ages 3 and 4 | 
| Problem behaviors | Observational protocol (DB-DOS) | Measured post-intervention at ages 3 and 4 | 
| Attachment | Strange Situation - lab based assessment | Measured post-intervention at age 2-4 | 
| Executive functioning | Dimensional change card sort | Measured at ages 3 and 4 | 
| Emotion regulation | Perfect circle | Measured at ages 3 and 4 | 
| Problem behaviors | Child Behavior Checklist | Ages 3 and 4 | 
| Executive functioning | Day-night Stroop | Ages 3 and 4 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Internationally Adopted Children, Adoption, Attachment, Inattention, Prevention