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

NCT ID: NCT00816621

Last Updated: 2021-06-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2021-03-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Attachment Disorders

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

ABC for Children Adopted Internationally

Intervention Type 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.

DEF for Children Adopted Internationally

DEF for Children Adopted Internationally: 10 session in home intervention that targets cognitive and motor delays

Group Type ACTIVE_COMPARATOR

DEF for Children Adopted Internationally

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Attachment and Biobehavioral Catch-up ABC ABC-I DEF PT/OT Physical Therapy/Occupational Therapy

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Adopted a child internationally

Exclusion Criteria

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

12 Months

Maximum Eligible Age

36 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

University of Delaware

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mary Dozier

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Mary Dozier, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Delaware

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Delaware

Newark, Delaware, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Yarger HA, Lind T, Raby KL, Zajac L, Wallin A, Dozier M. Intervening With Attachment and Biobehavioral Catch-Up to Reduce Behavior Problems Among Children Adopted Internationally: Evidence From a Randomized Controlled Trial. Child Maltreat. 2022 Aug;27(3):478-489. doi: 10.1177/10775595211010975. Epub 2021 Apr 22.

Reference Type DERIVED
PMID: 33882710 (View on PubMed)

Lind T, Lee Raby K, Goldstein A, Bernard K, Caron EB, Yarger HA, Wallin A, Dozier M. Improving social-emotional competence in internationally adopted children with the Attachment and Biobehavioral Catch-up intervention. Dev Psychopathol. 2021 Aug;33(3):957-969. doi: 10.1017/S0954579420000255.

Reference Type DERIVED
PMID: 32672145 (View on PubMed)

Yarger HA, Bernard K, Caron EB, Wallin A, Dozier M. Enhancing Parenting Quality for Young Children Adopted Internationally: Results of a Randomized Controlled Trial. J Clin Child Adolesc Psychol. 2020 May-Jun;49(3):378-390. doi: 10.1080/15374416.2018.1547972. Epub 2019 Jan 16.

Reference Type DERIVED
PMID: 30649970 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R01MH084135

Identifier Type: NIH

Identifier Source: secondary_id

View Link

DSIR 84-CTP

Identifier Type: -

Identifier Source: secondary_id

R01MH084135

Identifier Type: NIH

Identifier Source: org_study_id

View Link

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Family Health and Development Project
NCT01567969 COMPLETED PHASE3