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NCT Number: NCT06835855

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

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.

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Key information

Age range

6 month and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Binghamton University

Binghamton, New York, 13902, United States

Location status: Recruiting

Location contact

Brandon E Gibb, Ph.D.

CONTACT

[email protected]

607-777-2511

Brandon E Gibb, Ph.D.

PRINCIPAL_INVESTIGATOR

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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.

Treatment and study plan

Passive Viewing Task

Other

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.

Interaction Task

Other

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 play with their child. They 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.

Primary outcomes

  1. Eye gaze during computer-based task

    Time frame: 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

  2. Eye gaze during the interaction task

    Time frame: 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)

  3. Infant Heart Rate

    Time frame: 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.

  4. Infant Respiratory Sinus Arrhythmia

    Time frame: 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.

Secondary outcomes

  1. Infant social-emotional problems

    Time frame: Baseline and 3-, 6-, 9-, and 12-month follow-ups

    Infants' social-emotional problems will be assessed using mother reports on the Ages and Stages Questionnaire: Social-Emotional, Second Edition (ASQ:SE-2). Higher scores on the ASQ:SE-2 reflect greater social-emotional problems.

Study contacts

Contact information is provided by the study sponsor or research team.

Brandon E Gibb, Ph.D.

CONTACT

[email protected]

607-777-2511

Sponsors and collaborators

Lead sponsor

Binghamton University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Feb 19, 2025
Registry last updated
Feb 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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