Clinical trial NCT06835855: Development of Attentional Biases for Affective Cues in Infants of Mothers With Depression
Official title: Development of Attentional Biases for Affective Cues in Infants of Mothers With Depression
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depression - Major Depressive Disorder
Keywords: postpartum
infant
attention
psychophysiology
Lead sponsor: Binghamton University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2025-02-19
Enrollment: 225
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Eye gaze during computer-based task
timeFrame: Baseline and 3-, 6-, 9-, and 12-month follow-up
measure: Eye gaze during the interaction task
timeFrame: Baseline and 3-, 6-, 9-, and 12-month follow-up
measure: Infant Heart Rate
timeFrame: Baseline and 3-, 6-, 9-, and 12-month follow-up
measure: Infant Respiratory Sinus Arrhythmia
timeFrame: Baseline and 3-, 6-, 9-, and 12-month follow ups
Secondary outcomes:
measure: Infant social-emotional problems
timeFrame: Baseline and 3-, 6-, 9-, and 12-month follow-ups
Other outcomes:
Locations:
city: Binghamton
country: United States
facility: Binghamton University
state: New York
Study officials:
References: