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

Not Applicable

Recruiting

• Conditions: Depression - Major Depressive Disorder

• Registration Number: NCT06835855
• Lead Sponsor: Binghamton University

Brief Summary

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.

Detailed Description

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).

Study Timeline

• Study Start: 2024-11-14
• Study First Submitted: 2025-01-17
• Status Verified: 2025-02
• Study First Submitted QC: 2025-02-14
• Study First Posted: 2025-02-19
• Last Update Submitted: 2025-02-19
• Last Update Posted: 2025-02-20
• Primary Completion: 2029-02
• Study Completion: 2029-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 225

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Eye gaze during computer-based task	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	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	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	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 Outcome Measures

Name	Time	Method
Infant social-emotional problems	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.

Trial Locations

Locations (1)

Binghamton University; 🇺🇸 Binghamton, New York, United States