Evaluating the Efficacy of ABC for High-Risk Parent and Infants

April 16, 2018 updated by: Kristin Bernard, Stony Brook University
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.

Study Overview

Status

Unknown

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

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • New York
      • Brooklyn, New York, United States, 11212
        • Power of Two

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Kristin Bernard, PhD, Stony Brook University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Anticipated)

October 1, 2018

Study Completion (Anticipated)

October 1, 2018

Study Registration Dates

First Submitted

January 4, 2016

First Submitted That Met QC Criteria

January 5, 2016

First Posted (Estimate)

January 6, 2016

Study Record Updates

Last Update Posted (Actual)

April 18, 2018

Last Update Submitted That Met QC Criteria

April 16, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

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.

Clinical Trials on Attachment Disorders

Clinical Trials on Attachment and Biobehavioral Catch-up (ABC)

3
Subscribe