NCT00816621

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 30, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 1, 2009

Completed
Same day until next milestone

Study Start

First participant enrolled

January 1, 2009

Completed
11.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2021

Completed
Last Updated

June 2, 2021

Status Verified

May 1, 2021

Enrollment Period

11.9 years

First QC Date

December 30, 2008

Last Update Submit

May 30, 2021

Conditions

Attachment Disorders

Keywords

Internationally Adopted ChildrenAdoptionAttachmentInattentionPrevention

Outcome Measures

Primary Outcomes (1)

  • Inattention

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

Secondary Outcomes (8)

  • Cortisol production

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

  • Competence

    Measured post-intervention at ages 3 and 4

  • Problem behaviors

    Measured post-intervention at ages 3 and 4

  • Attachment

    Measured post-intervention at age 2-4

  • Executive functioning

    Measured at ages 3 and 4

  • +3 more secondary outcomes

Study Arms (2)

ABC for Children Adopted Internationally

EXPERIMENTAL

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

DEF for Children Adopted Internationally

ACTIVE COMPARATOR

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

Behavioral: DEF for Children Adopted Internationally

Interventions

ABC for Children Adopted InternationallyBEHAVIORAL

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.

Also known as: Attachment and Biobehavioral Catch-up, ABC, ABC-I
ABC for Children Adopted Internationally
DEF for Children Adopted InternationallyBEHAVIORAL

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

Also known as: DEF, PT/OT, Physical Therapy/Occupational Therapy
DEF for Children Adopted Internationally

Eligibility Criteria

Age12 Months - 36 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Adopted a child internationally

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Delaware

Newark, Delaware, 19716, United States

Location

Related Publications (3)

  • 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.

    PMID: 33882710DERIVED

  • 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.

    PMID: 32672145DERIVED

  • 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.

    PMID: 30649970DERIVED

MeSH Terms

Interventions

abacavirbutyl phosphorotrithioatePhysical Therapy ModalitiesOccupational Therapy

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitationAftercareContinuity of Patient CarePatient Care

Study Officials

  • Mary Dozier, PhD

    University of Delaware

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 30, 2008

First Posted

January 1, 2009

Study Start

January 1, 2009

Primary Completion

December 10, 2020

Study Completion

March 20, 2021

Last Updated

June 2, 2021

Record last verified: 2021-05

Locations

US(1)