Health TrialsbyHealthPanel

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

ConditionDepression - Major Depressive Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6+
SponsorBinghamton University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Passive Viewing Task

    Other intervention

    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 intervention

    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.

Treatment groups

225 Participants
are divided into 1 treatment group
Group A: Experimental protocol for all infantsExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
Baseline and 3-, 6-, 9-, and 12-month follow-up
2

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)

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

Infant Heart Rate

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

Time frame
Baseline and 3-, 6-, 9-, and 12-month follow-up
4

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.

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

Secondary outcomes

1

Infant social-emotional problems

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.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Binghamton University

Lead sponsor

National Institute of Mental Health (NIMH)

Collaborator

Source ClinicalTrials.gov
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