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

Early Intervention for Children Adopted Internationally

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00816621
Enrollment
220
Registered
2009-01-01
Start date
2009-01-31
Completion date
2021-03-20
Last updated
2021-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Attachment Disorders

Keywords

Internationally Adopted Children, Adoption, Attachment, Inattention, 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.

Interventions

BEHAVIORALABC 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.

BEHAVIORALDEF for Children Adopted Internationally

Participants will participate in 10 weekly in-home intervention sessions aimed at enhancing the intellectual and language development of children.

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
University of Delaware
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
12 Months to 36 Months
Healthy volunteers
Yes

Inclusion criteria

* Adopted a child internationally

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
InattentionMeasured pre-intervention, post-intervention, and when the child turns 2, 3, and 4

Secondary

MeasureTime frameDescription
Cortisol productionMeasured pre-intervention, post-intervention, and when the child turns 2, 3, and 4Salivary cortisol measured at wake-up and bedtime. Eliza assay will be used.
CompetenceMeasured post-intervention at ages 3 and 4Observational protocol from Disruptive Behaviors-Diagnostic Observation Scale (DB-DOS)
Emotion regulationMeasured at ages 3 and 4Perfect circle
AttachmentMeasured post-intervention at age 2-4Strange Situation - lab based assessment
Executive functioningMeasured at ages 3 and 4Dimensional change card sort
Problem behaviorsMeasured post-intervention at ages 3 and 4Observational protocol (DB-DOS)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 22, 2026