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

Attachment Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02647463
• Other study ID #: FCNY-73312
• Status: Active, not recruiting
• Phase: N/A
• First received: January 4, 2016
• Last updated: April 16, 2018
• Start date: January 2016
• Est. completion date: October 2018

Study information

• Verified date: April 2018
• Source: Stony Brook University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: October 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 20 Months

Eligibility

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

Related Conditions & MeSH terms

• Attachment Disorders

Intervention

Behavioral:
• Attachment and Biobehavioral Catch-up (ABC)

Locations

Country	Name	City	State
United States	Power of Two	Brooklyn	New York

Sponsors (1)

Lead Sponsor	Collaborator
Stony Brook University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Attachment organization/security	Assessed via Strange Situation Procedure (observational)	1-3 months post-intervention
Secondary	Diurnal cortisol regulation	Assessed via saliva samples collected from infants	1-3 months post-intervention
Secondary	Parent sensitivity	Observational assessment of parents' following the lead, intrusiveness, and delight	1-3 months post-intervention