Evaluating the Efficacy of ABC for High-Risk Parent and Infants
1 other identifier
interventional
200
1 country
1
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2016
CompletedFirst Submitted
Initial submission to the registry
January 4, 2016
CompletedFirst Posted
Study publicly available on registry
January 6, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2018
CompletedApril 18, 2018
April 1, 2018
2.8 years
January 4, 2016
April 16, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Attachment organization/security
Assessed via Strange Situation Procedure (observational)
1-3 months post-intervention
Secondary Outcomes (2)
Diurnal cortisol regulation
1-3 months post-intervention
Parent sensitivity
1-3 months post-intervention
Study Arms (2)
Attachment and Biobehavioral Catch-up
EXPERIMENTAL10-session intervention for parents and infants aimed at increasing parents' nurturance and following the lead, and reducing frightening behavior
Waitlist Control
NO INTERVENTIONWaitlist Control
Interventions
Eligibility Criteria
You may qualify if:
- Infant between 6 and 20 months old at time of enrollment
- Living with primary caregiver
You may not qualify if:
- Infant will be excluded if he/she has significant medical or developmental problems
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Power of Two
Brooklyn, New York, 11212, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Kristin Bernard, PhD
Stony Brook University
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
- Assistant Professor
Study Record Dates
First Submitted
January 4, 2016
First Posted
January 6, 2016
Study Start
January 1, 2016
Primary Completion
October 1, 2018
Study Completion
October 1, 2018
Last Updated
April 18, 2018
Record last verified: 2018-04