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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06835855
Enrollment
225
Registered
2025-02-19
Start date
2024-11-14
Completion date
2029-07-31
Last updated
2025-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression - Major Depressive Disorder

Keywords

postpartum, infant, attention, psychophysiology

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).

Interventions

OTHERInteraction 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.

OTHERPassive 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.

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
Binghamton University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Months to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Eye gaze during computer-based taskBaseline and 3-, 6-, 9-, and 12-month follow-upUsed 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 taskBaseline and 3-, 6-, 9-, and 12-month follow-upUsed 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 RateBaseline and 3-, 6-, 9-, and 12-month follow-upDuring the interaction tasks, the investigators will record infant electrocardiography (ECG) to calculate heart rate (HR) using a MindWare Mobile system.
Infant Respiratory Sinus ArrhythmiaBaseline and 3-, 6-, 9-, and 12-month follow upsDuring 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

MeasureTime frameDescription
Infant social-emotional problemsBaseline and 3-, 6-, 9-, and 12-month follow-upsInfants' 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.

Countries

United States

Contacts

Primary ContactBrandon E Gibb, Ph.D.
bgibb@binghamton.edu607-777-2511

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026