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

Attachment Disorders Clinical Trial

Official title:

Early Intervention for Children Adopted Internationally

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00816621
• Other study ID #: R01MH084135
• Secondary ID: R01MH084135DSIR
• Status: Completed
• Phase: N/A
• Start date: January 2009
• Est. completion date: March 20, 2021

Study information

• Verified date: May 2021
• Source: University of Delaware
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: March 20, 2021
• Est. primary completion date: December 10, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Months to 36 Months

Eligibility

Inclusion Criteria:

• Adopted a child internationally

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Attachment Disorders

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Delaware	Newark	Delaware

Sponsors (2)

Lead Sponsor	Collaborator
University of Delaware	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

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

External Links

•   Click here for more information on the Infant Caregiver Project