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临床试验/NCT06835855
NCT06835855招募中不适用

Development of Attentional Biases for Affective Cues in Infants of Mothers with Depression

Binghamton University2 个研究点 分布在 1 个国家目标入组 225 人开始时间: 2024年11月14日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
225
试验地点
2
主要终点
Eye gaze during computer-based task

研究概览

简要总结

The goal of this study is to examine attentional biases for facial displays of emotion as a mechanism of risk in infants of mothers with postpartum major depression, and the potential role of infant arousal in the development of these attentional biases.

详细描述

As part of the study protocol, infants will complete a computer-based task in which they view facial displays of emotion (angry, happy, sad, neutral) while an eye tracker records their gaze. Mother and infants will also complete a standardized interaction task during which the investigators assess infant gaze and psychophysiology. The task consists of three stages, each of which lasts three minutes. For the first stage (Free Play 1), infants sit in a highchair and mothers are asked to play with their baby as they normally would, without any toys or other objects. In the second stage (Sad), mothers are asked to think about times when they are sad or depressed and do not feel able to effectively play with their child. Mothers are instructed to look at their child but speak in a monotone and minimize body movement or any physical contact with the infant. In the third stage (Free Play 2), mothers again interact with their infants normally for three minutes. These two tasks are consistent with the definition of a Basic Experimental Study in Humans (BESH).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
6 Months 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • The high-risk group (n = 150) will consist of women with at least one episode of MDD since their baby's birth.
  • To qualify for the low-risk group (n = 75), women cannot have a history of any depressive disorder or any current psychiatric diagnoses.
  • Infants will be required to be singleton children born full-term (> 37 weeks) and normal weight (> 2,500 grams) with no birth complications or health problems to avoid medical complications contributing to infants' attention, reactivity, and regulation measures.
  • The two groups will be matched on demographic factors (e.g., age, race/ethnicity, income).

排除标准

  • Additional exclusion criteria are diagnoses of alcohol or substance use disorders currently or at any point during pregnancy, or lifetime history of bipolar or psychotic disorders.

结局指标

主要结局

Eye gaze during computer-based task

时间窗: Baseline and 3-, 6-, 9-, and 12-month follow-up

Used to determine percent of infant attention allocated to each emotional stimulus type (angry, happy, sad, neutral) during the computer-based task

Eye gaze during the interaction task

时间窗: Baseline and 3-, 6-, 9-, and 12-month follow-up

Used to assess the proportion of time during each phase of the interaction task that babies look at their mother (versus away from their mother)

Infant Heart Rate

时间窗: Baseline and 3-, 6-, 9-, and 12-month follow-up

During the interaction tasks, the investigators will record infant electrocardiography (ECG) to calculate heart rate (HR) using a MindWare Mobile system.

Infant Respiratory Sinus Arrhythmia

时间窗: Baseline and 3-, 6-, 9-, and 12-month follow ups

During the interaction tasks, the investigators will record infant electrocardiography (ECG) to calculate respiratory sinus arrhythmia (RSA) using a MindWare Mobile system. To calculate RSA, spectral power analyses will be performed with a fast Fourier transformation. RSA will be defined as power density in the .24-1.04 Hz frequency band and will be calculated for each 30 s epoch of each task.

次要结局

  • Infant social-emotional problems(Baseline and 3-, 6-, 9-, and 12-month follow-ups)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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