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临床试验/NCT02647463
NCT02647463Unknown不适用

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

Stony Brook University2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2016年1月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
200
试验地点
2
主要终点
Attachment organization/security

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
6 Months 至 20 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Infant between 6 and 20 months old at time of enrollment
  • Living with primary caregiver

排除标准

  • Infant will be excluded if he/she has significant medical or developmental problems

研究组 & 干预措施

Attachment and Biobehavioral Catch-up

Experimental

10-session intervention for parents and infants aimed at increasing parents' nurturance and following the lead, and reducing frightening behavior

干预措施: Attachment and Biobehavioral Catch-up (ABC) (Behavioral)

Waitlist Control

No Intervention

Waitlist Control

结局指标

主要结局

Attachment organization/security

时间窗: 1-3 months post-intervention

Assessed via Strange Situation Procedure (observational)

次要结局

  • Parent sensitivity(1-3 months post-intervention)
  • Diurnal cortisol regulation(1-3 months post-intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kristin Bernard

Assistant Professor

Stony Brook University

研究点 (2)

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