Clinical trial NCT02647463: Evaluating the Efficacy of ABC for High-Risk Parent and Infants
Official title: Evaluating the Efficacy of ABC for High-Risk Parent and Infants
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Attachment Disorders
Keywords: Attachment
Cortisol
Parent sensitivity
Lead sponsor: Stony Brook University
Sponsor class: OTHER
First posted: 2016-01-06
Enrollment: 200
Sex: ALL
Minimum age (years): 6
Maximum age (years): 20
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Attachment organization/security
timeFrame: 1-3 months post-intervention
Secondary outcomes:
measure: Diurnal cortisol regulation
timeFrame: 1-3 months post-intervention
measure: Parent sensitivity
timeFrame: 1-3 months post-intervention
Other outcomes:
Locations:
city: Brooklyn
country: United States
facility: Power of Two
state: New York
Study officials:
affiliation: Stony Brook University
name: Kristin Bernard, PhD
role: PRINCIPAL_INVESTIGATOR
References: