NCT06835855 · Binghamton University
Development of Attentional Biases for Affective Cues in Infants of Mothers With Depression
What this study is about
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.
View original scientific description
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.
Interventions
OTHER
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.
OTHER
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 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 outcome measures
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
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)
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.
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Binghamton, New York
Collaborators
National Institute of Mental Health (NIMH)
Related conditions & keywords
Frequently asked questions
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Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
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Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
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Data: ClinicalTrials.gov · synced Feb 20, 2025 · Source of record for eligibility and locations