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

NCT06835855 | Recruiting

• 2 other identifiers: STUDY00004999R01MH132667
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression - Major Depressive Disorder

Keywords

postpartum; infant; attention; psychophysiology

Outcome Measures

Primary Outcomes (4)

• Eye gaze during computer-based task

  Used to determine percent of infant attention allocated to each emotional stimulus type (angry, happy, sad, neutral) during the computer-based task

  Baseline and 3-, 6-, 9-, and 12-month follow-up

• Eye gaze during the interaction task

  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)

  Baseline and 3-, 6-, 9-, and 12-month follow-up

• Infant Heart Rate

  During the interaction tasks, the investigators will record infant electrocardiography (ECG) to calculate heart rate (HR) using a MindWare Mobile system.

  Baseline and 3-, 6-, 9-, and 12-month follow-up

• Infant Respiratory Sinus Arrhythmia

  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.

  Baseline and 3-, 6-, 9-, and 12-month follow ups

Secondary Outcomes (1)

• Infant social-emotional problems

  Baseline and 3-, 6-, 9-, and 12-month follow-ups

Study Arms (1)

Experimental protocol for all infants

EXPERIMENTAL

Other: Passive Viewing Task; Other: Interaction Task

Interventions

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.

Experimental protocol for all infants

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.

Experimental protocol for all infants

Eligibility Criteria

• Age: 6 Months+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

Sponsors & Collaborators

• Binghamton University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Binghamton University

Binghamton, New York, 13902, United States

RECRUITING

Central Study Contacts

Brandon E Gibb, Ph.D.

CONTACT

607-777-2511; bgibb@binghamton.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2025
• First Posted: February 19, 2025
• Study Start: November 14, 2024
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): July 1, 2029
• Last Updated: February 20, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Time Frame: All data will be deposited to NDA starting 12 months after the award begins and will be deposited every six months thereafter following the usual NDA data submission dates.
• Access Criteria: Data will be findable for the research community through the NDA Collection that established when this application was funded. For all publications, an NDA study will be created. Each of those studies is assigned a digital object identifier (DOI). This data DOI will be referenced in the publication to allow the research community easy access to the exact data used in the publication.

Locations

US (1)