Attachment DisordersNCT00816621
Effectiveness of a Parent Training Program for Parents of Children Adopted Internationally
A study testing ABC for Children Adopted Internationally and DEF for Children Adopted Internationally in people with Attachment Disorders, run by University of Delaware at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 12 to 36 monthsHealthy volunteers can take part
- Conditions the study is for
- Attachment Disorders
- What is being tested?
- ABC for Children Adopted Internationally and DEF for Children Adopted Internationally
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to 20 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 36 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Adopted a child internationally
Who cannot join
- Child has known serious medical condition, such as cerebral palsy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Intervention for 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.
Read the 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.
- Conditions
- Attachment Disorders
- Being tested
- ABC for Children Adopted Internationally, DEF for Children Adopted Internationally
- Keywords
- Internationally Adopted Children, Adoption, Attachment, Inattention, Prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABC for Children Adopted InternationallyBehavioural
Also called Attachment and Biobehavioral Catch-up, ABC, ABC-I
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 InternationallyBehavioural
Also called DEF, PT/OT, Physical Therapy/Occupational Therapy
Participants will participate in 10 weekly in-home intervention sessions aimed at enhancing the intellectual and language development of children.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Behavioral: DEF for Children Adopted Internationally |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inattention
Measured: Measured pre-intervention, post-intervention, and when the child turns 2, 3, and 4
Secondary outcomes (8)
Cortisol production
Salivary cortisol measured at wake-up and bedtime. Eliza assay will be used.
Measured: Measured pre-intervention, post-intervention, and when the child turns 2, 3, and 4
Competence
Observational protocol from Disruptive Behaviors-Diagnostic Observation Scale (DB-DOS)
Measured: Measured post-intervention at ages 3 and 4
Problem behaviors
Observational protocol (DB-DOS)
Measured: Measured post-intervention at ages 3 and 4
Attachment
"Strange Situation" - lab based assessment
Measured: Measured post-intervention at age 2-4
Executive functioning
Dimensional change card sort
Measured: Measured at ages 3 and 4
Emotion regulation
Perfect circle
Measured: Measured at ages 3 and 4
Problem behaviors
Child Behavior Checklist
Measured: Ages 3 and 4
Executive functioning
Day-night Stroop
Measured: Ages 3 and 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2009 (estimated)
- Study startJan 2009
- Primary completion10 Dec 2020
- Study completion20 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Attachment DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Delaware
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Mary Dozier, University of Delaware
- Investigators
- Mary Dozier, PhD, Principal investigator, University of Delaware
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00816621
- Sponsor's protocol ID
- R01MH084135
- Other IDs
- R01MH084135, DSIR 84-CTP
- Status last verified
- May 2021
- First submitted
- 30 Dec 2008
- Last updated
- 2 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 33882710Lind 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.
PubMed 32672145Yarger 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.
PubMed 30649970
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Intervention for Children Adopted Internationally
- ClinicalTrials.gov ID
- NCT00816621
- Acronym / sponsor ID
- R01MH084135
- Conditions
- Attachment Disorders
- Keywords
- Internationally Adopted Children, Adoption, Attachment, Inattention, Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- University of DelawareUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jan 2009 (actual)
- Primary completion
- 10 Dec 2020 (actual)
- Study completion
- 20 Mar 2021 (actual)
- First posted
- 1 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ABC for Children Adopted Internationally | Experimental | Behavioral: ABC for Children Adopted InternationallyABC for Children Adopted Internationally: 10 session in home intervention that targets parent nurturance, synchrony, pseudo-autistic behaviors, and indiscriminate sociability |
| DEF for Children Adopted Internationally | Active comparator | Behavioral: DEF for Children Adopted InternationallyDEF for Children Adopted Internationally: 10 session in home intervention that targets cognitive and motor delays |
Who may qualify
- Ages
- 12 to 36 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Adopted a child internationally
Key exclusion criteria (1 listed)
- Child has known serious medical condition, such as cerebral palsy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABC for Children Adopted InternationallyAlso: Attachment and Biobehavioral Catch-up, ABC, ABC-IParticipants 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. | Behavioural | ABC for Children Adopted Internationally |
| DEF for Children Adopted InternationallyAlso: DEF, PT/OT, Physical Therapy/Occupational TherapyParticipants will participate in 10 weekly in-home intervention sessions aimed at enhancing the intellectual and language development of children. | Behavioural | DEF for Children Adopted Internationally |
Primary outcome
Inattention
Time frame: Measured pre-intervention, post-intervention, and when the child turns 2, 3, and 4
8 secondary outcomes
Cortisol production
Time frame: Measured pre-intervention, post-intervention, and when the child turns 2, 3, and 4
Competence
Time frame: Measured post-intervention at ages 3 and 4
Problem behaviors
Time frame: Measured post-intervention at ages 3 and 4
Attachment
Time frame: Measured post-intervention at age 2-4
Executive functioning
Time frame: Measured at ages 3 and 4
Emotion regulation
Time frame: Measured at ages 3 and 4
Problem behaviors
Time frame: Ages 3 and 4
Executive functioning
Time frame: Ages 3 and 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2021.
- Derived from this study: PubMed 33882710Yarger 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.
- Derived from this study: PubMed 32672145Lind 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.
- Derived from this study: PubMed 30649970Yarger 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary Dozier, PhD principal investigator
University of Delaware
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ABC for Children Adopted Internationally and DEF for Children Adopted Internationally in people with Attachment Disorders, run by University of Delaware at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inattention (time frame: Measured pre-intervention, post-intervention, and when the child turns 2, 3, and 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00816621, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2021.