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

May 30, 2021 updated by: Mary Dozier, University of Delaware

Early Intervention for Children Adopted Internationally

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

220

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Delaware
      • Newark, Delaware, United States, 19716
        • University of Delaware

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 5 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adopted a child internationally

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Other Names:
  • ABC
  • Attachment and Biobehavioral Catch-up
  • ABC-I
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.
Other Names:
  • DEF
  • PT/OT
  • Physical Therapy/Occupational Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Inattention
Time Frame: Measured pre-intervention, post-intervention, and when the child turns 2, 3, and 4
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
Time Frame: Measured pre-intervention, post-intervention, and when the child turns 2, 3, and 4
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
Time Frame: Measured post-intervention at ages 3 and 4
Observational protocol from Disruptive Behaviors-Diagnostic Observation Scale (DB-DOS)
Measured post-intervention at ages 3 and 4
Problem behaviors
Time Frame: Measured post-intervention at ages 3 and 4
Observational protocol (DB-DOS)
Measured post-intervention at ages 3 and 4
Attachment
Time Frame: Measured post-intervention at age 2-4
"Strange Situation" - lab based assessment
Measured post-intervention at age 2-4
Executive functioning
Time Frame: Measured at ages 3 and 4
Dimensional change card sort
Measured at ages 3 and 4
Emotion regulation
Time Frame: Measured at ages 3 and 4
Perfect circle
Measured at ages 3 and 4
Problem behaviors
Time Frame: Ages 3 and 4
Child Behavior Checklist
Ages 3 and 4
Executive functioning
Time Frame: Ages 3 and 4
Day-night Stroop
Ages 3 and 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Delaware

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Mary Dozier, PhD, University of Delaware

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2009

Primary Completion (Actual)

December 10, 2020

Study Completion (Actual)

March 20, 2021

Study Registration Dates

First Submitted

December 30, 2008

First Submitted That Met QC Criteria

December 30, 2008

First Posted (Estimate)

January 1, 2009

Study Record Updates

Last Update Posted (Actual)

June 2, 2021

Last Update Submitted That Met QC Criteria

May 30, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • R01MH084135 (U.S. NIH Grant/Contract)
  • DSIR 84-CTP (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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