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Completed

NCT Number: NCT00816621

Effectiveness of a Parent Training Program for Parents of 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.

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Key information

Age range

12 month–36 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Delaware

Newark, Delaware, 19716, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adopted a child internationally

Exclusion criteria

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

Treatment and study plan

ABC for Children Adopted Internationally

Behavioral

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: Attachment and Biobehavioral Catch-up, ABC, ABC-I

DEF for Children Adopted Internationally

Behavioral

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

Primary outcomes

  1. Inattention

    Time frame: Measured pre-intervention, post-intervention, and when the child turns 2, 3, and 4

Secondary outcomes

  1. 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.

  2. Competence

    Time frame: Measured post-intervention at ages 3 and 4

    Observational protocol from Disruptive Behaviors-Diagnostic Observation Scale (DB-DOS)

  3. Problem behaviors

    Time frame: Measured post-intervention at ages 3 and 4

    Observational protocol (DB-DOS)

  4. Attachment

    Time frame: Measured post-intervention at age 2-4

    "Strange Situation" - lab based assessment

  5. Executive functioning

    Time frame: Measured at ages 3 and 4

    Dimensional change card sort

  6. Emotion regulation

    Time frame: Measured at ages 3 and 4

    Perfect circle

  7. Problem behaviors

    Time frame: Ages 3 and 4

    Child Behavior Checklist

  8. Executive functioning

    Time frame: Ages 3 and 4

    Day-night Stroop

Sponsors and collaborators

Lead sponsor

University of Delaware

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Early Intervention for Children Adopted Internationally

Important dates

Study start
2009
Primary completion
2020
Study completion
2021
First posted
Jan 1, 2009
Registry last updated
Jun 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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