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Идёт набор NCT06835855

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

Без фазы С лечением Depression - Major Depressive Disorder

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Passive Viewing Task, Interaction Task.
Кому может быть актуально
Состояния в реестре: Depression - Major Depressive Disorder. Базовые параметры: от 6 мес. · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Обзор

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.

Подробное описание

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).

Вмешательства

  • Другое Passive Viewing Task
    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.
  • Другое Interaction Task
    Mother and infants will also complete a standardized interaction task during which we 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 pla

Первичные конечные точки

  • Eye gaze during computer-based task [Срок оценки: Baseline and 3-, 6-, 9-, and 12-month follow-up]
  • Eye gaze during the interaction task [Срок оценки: Baseline and 3-, 6-, 9-, and 12-month follow-up]
  • Infant Heart Rate [Срок оценки: Baseline and 3-, 6-, 9-, and 12-month follow-up]
  • Infant Respiratory Sinus Arrhythmia [Срок оценки: Baseline and 3-, 6-, 9-, and 12-month follow ups]
Вторичные конечные точки (1)
  • Infant social-emotional problems [Срок оценки: Baseline and 3-, 6-, 9-, and 12-month follow-ups]

Критерии участия

Критерии включения

  • 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).

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Фундаментальное исследование

Центры проведения

США · 1 центр
  • Binghamton University — Binghamton

Идентификаторы

NCT: NCT06835855 · STUDY00004999 · R01MH132667

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗