- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02647463
Evaluating the Efficacy of ABC for High-Risk Parent and Infants
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
Brooklyn, New York, United States, 11212
- Power of Two
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Infant between 6 and 20 months old at time of enrollment
- Living with primary caregiver
Exclusion Criteria:
- Infant will be excluded if he/she has significant medical or developmental problems
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Attachment and Biobehavioral Catch-up
10-session intervention for parents and infants aimed at increasing parents' nurturance and following the lead, and reducing frightening behavior
|
|
No Intervention: Waitlist Control
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Attachment organization/security
Time Frame: 1-3 months post-intervention
|
Assessed via Strange Situation Procedure (observational)
|
1-3 months post-intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Diurnal cortisol regulation
Time Frame: 1-3 months post-intervention
|
Assessed via saliva samples collected from infants
|
1-3 months post-intervention
|
Parent sensitivity
Time Frame: 1-3 months post-intervention
|
Observational assessment of parents' following the lead, intrusiveness, and delight
|
1-3 months post-intervention
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kristin Bernard, PhD, Stony Brook University
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- FCNY-73312
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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