Attachment DisordersNCT02647463
Evaluating the Efficacy of ABC for High-Risk Parent and Infants
A study testing Attachment and Biobehavioral Catch-up (ABC) in people with Attachment Disorders, run by Stony Brook University at 1 site in United States.
Trial summary
Attachment and Biobehavioral Catch-up (ABC) is a manualized 10-session intervention delivered in families' homes or other places of residence. By helping parents of infants provide nurturance when their children are in distress, follow their children's lead, and behave in non-frightening ways, the ABC intervention has… Read more about this study
- Who is it for?
- Ages 6 to 20 monthsHealthy volunteers can take part
- Conditions the study is for
- Attachment Disorders
- What is being tested?
- Attachment and Biobehavioral Catch-up (ABC)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to Oct 2018
- 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 6 to 20 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Infant between 6 and 20 months old at time of enrollment
- Living with primary caregiver
Who cannot join
- Infant will be excluded if he/she has significant medical or developmental problems
Trial locations and contacts
1 site in 1 country.
About this study
Attachment and Biobehavioral Catch-up (ABC) is a manualized 10-session intervention delivered in families' homes or other places of residence. By helping parents of infants provide nurturance when their children are in distress, follow their children's lead, and behave in non-frightening ways, the ABC intervention has been previously found to enhance children's attachment quality and children's ability to regulate behavior, physiology, and emotions. The purpose of the present study is to examine the effectiveness of ABC in the context of community-based implementation efforts. Outcome assessments will include parent sensitivity, attachment quality, and cortisol regulation. The investigators hypothesize that parents randomly assigned to receive the ABC intervention will show higher levels of sensitivity at follow-up than parents randomly assigned to the waitlist control condition; and children randomly assigned to the ABC intervention will show higher rates of secure attachment and more normative profiles of cortisol than children randomly assigned to the waitlist condition.
Read the detailed description
Chronic stress in early childhood, the result of living in poverty, exposure to violence, and/or experiencing abuse or neglect, undermines a child's development in ways that may have lasting consequences for well-being later in life. High quality parenting (i.e., responding sensitively when children are distressed, and following children's lead) appears to protect against the negative effects of chronic stress, likely by supporting the development of secure attachments and good self-regulation. Unfortunately, many caregivers living in poverty, through no fault of their own, are unable to parent in ways that provide this protection.
Children who face early adversity especially need nurturing, synchronous, and non-frightening care. The ABC intervention was developed to target these three parenting behaviors, with the goal of enhancing attachment relationships and regulatory capacities (Dozier et al., 2011). The ABC intervention is a manualized 10-session program delivered in the parent's home or other place of residence (e.g., homeless shelter). Sessions are videotaped for purposes of video feedback (i.e., showing brief clips back to parents for review of target behaviors), supervision, and fidelity monitoring.
Power of Two is a new non-profit organization in Brooklyn, NY that is implementing the ABC intervention for vulnerable families living in poverty. The purpose of the present study is to examine the effectiveness of ABC in the context of Power of Two's community-based implementation efforts. Using a short-term randomized control design, the investigators aim to replicate and extend previous findings regarding the efficacy of ABC. Participants will include 120 families with infants between 6 months and 20 months of age. Upon referral to the project, families will be randomly assigned to receive the ABC intervention immediately, or be put on a waitlist to receive the ABC intervention after approximately 3 months. Outcome assessments will include: (1) parent sensitivity (assessed at pre-intervention and follow-up), (2) attachment quality (assessed at follow-up), and (3) cortisol regulation (assessed at pre-intervention and follow-up). Additional variables will be included as moderators and covariates.
- Conditions
- Attachment Disorders
- Being tested
- Attachment and Biobehavioral Catch-up (ABC)
- Keywords
- Attachment, Cortisol, Parent sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Attachment and Biobehavioral Catch-up (ABC)Behavioural
| Study group | Role | What they receive |
|---|---|---|
| Attachment and Biobehavioral Catch-up | Experimental | 10-session intervention for parents and infants aimed at increasing parents' nurturance and following the lead, and reducing frightening behavior Receives: Behavioral: Attachment and Biobehavioral Catch-up (ABC) |
| Waitlist Control | No intervention | Waitlist Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attachment organization/security
Assessed via Strange Situation Procedure (observational)
Measured: 1-3 months post-intervention
Secondary outcomes (2)
Diurnal cortisol regulation
Assessed via saliva samples collected from infants
Measured: 1-3 months post-intervention
Parent sensitivity
Observational assessment of parents' following the lead, intrusiveness, and delight
Measured: 1-3 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionOct 2018 (estimated)
- Study completionOct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stony Brook University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristin Bernard, Stony Brook University
- Investigators
- Kristin Bernard, PhD, Principal investigator, Stony Brook University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02647463
- Sponsor's protocol ID
- FCNY-73312
- Status last verified
- Apr 2018
- First submitted
- 4 Jan 2016
- Last updated
- 18 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Efficacy of ABC for High-Risk Parent and Infants
- ClinicalTrials.gov ID
- NCT02647463
- Acronym / sponsor ID
- FCNY-73312
- Conditions
- Attachment Disorders
- Keywords
- Attachment, Cortisol, Parent sensitivity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Stony Brook UniversityUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Oct 2018 (estimated)
- Study completion
- Oct 2018 (estimated)
- First posted
- 6 Jan 2016 (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.
Attachment and Biobehavioral Catch-up (ABC) is a manualized 10-session intervention delivered in families' homes or other places of residence. By helping parents of infants provide nurturance when their children are in distress, follow their children's lead, and behave in non-frightening ways, the ABC intervention has been previously found to enhance children's attachment quality and children's ability to regulate behavior, physiology, and emotions. The purpose of the present study is to examine the effectiveness of ABC in the context of community-based implementation efforts. Outcome assessments will include parent sensitivity, attachment quality, and cortisol regulation. The investigators hypothesize that parents randomly assigned to receive the ABC intervention will show higher levels of sensitivity at follow-up than parents randomly assigned to the waitlist control condition; and children randomly assigned to the ABC intervention will show higher rates of secure attachment and more normative profiles of cortisol than children randomly assigned to the waitlist condition.
Detailed description
Chronic stress in early childhood, the result of living in poverty, exposure to violence, and/or experiencing abuse or neglect, undermines a child's development in ways that may have lasting consequences for well-being later in life. High quality parenting (i.e., responding sensitively when children are distressed, and following children's lead) appears to protect against the negative effects of chronic stress, likely by supporting the development of secure attachments and good self-regulation. Unfortunately, many caregivers living in poverty, through no fault of their own, are unable to parent in ways that provide this protection.
Children who face early adversity especially need nurturing, synchronous, and non-frightening care. The ABC intervention was developed to target these three parenting behaviors, with the goal of enhancing attachment relationships and regulatory capacities (Dozier et al., 2011). The ABC intervention is a manualized 10-session program delivered in the parent's home or other place of residence (e.g., homeless shelter). Sessions are videotaped for purposes of video feedback (i.e., showing brief clips back to parents for review of target behaviors), supervision, and fidelity monitoring.
Power of Two is a new non-profit organization in Brooklyn, NY that is implementing the ABC intervention for vulnerable families living in poverty. The purpose of the present study is to examine the effectiveness of ABC in the context of Power of Two's community-based implementation efforts. Using a short-term randomized control design, the investigators aim to replicate and extend previous findings regarding the efficacy of ABC. Participants will include 120 families with infants between 6 months and 20 months of age. Upon referral to the project, families will be randomly assigned to receive the ABC intervention immediately, or be put on a waitlist to receive the ABC intervention after approximately 3 months. Outcome assessments will include: (1) parent sensitivity (assessed at pre-intervention and follow-up), (2) attachment quality (assessed at follow-up), and (3) cortisol regulation (assessed at pre-intervention and follow-up). Additional variables will be included as moderators and covariates.
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 |
|---|---|---|
| Attachment and Biobehavioral Catch-up | Experimental | Behavioral: Attachment and Biobehavioral Catch-up (ABC)10-session intervention for parents and infants aimed at increasing parents' nurturance and following the lead, and reducing frightening behavior |
| Waitlist Control | No intervention | –Waitlist Control |
Who may qualify
- Ages
- 6 to 20 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Infant between 6 and 20 months old at time of enrollment
- Living with primary caregiver
Key exclusion criteria (1 listed)
- Infant will be excluded if he/she has significant medical or developmental problems
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 |
|---|---|---|
| Attachment and Biobehavioral Catch-up (ABC) | Behavioural | Attachment and Biobehavioral Catch-up |
Primary outcome
Attachment organization/security
Time frame: 1-3 months post-intervention
Assessed via Strange Situation Procedure (observational)
2 secondary outcomes
Diurnal cortisol regulation
Time frame: 1-3 months post-intervention
Parent sensitivity
Time frame: 1-3 months post-intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2018.
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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.
Kristin Bernard, PhD principal investigator
Stony Brook University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Attachment and Biobehavioral Catch-up (ABC) in people with Attachment Disorders, run by Stony Brook University 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 2 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: status not confirmed, as of the sponsor's last update on 18 Apr 2018. 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?
Results are not available in the source record.
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?
Attachment organization/security (time frame: 1-3 months post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Apr 2018.