Development of Attentional Biases for Affective Cues in Infants of Mothers With Depression
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Passive Viewing Task, Interaction Task.
- Who it may be relevant to
- Registry conditions: Depression - Major Depressive Disorder. Basic parameters: from 6 months · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- 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 pla
Primary outcome measures
- Eye gaze during computer-based task [Time frame: Baseline and 3-, 6-, 9-, and 12-month follow-up]
- Eye gaze during the interaction task [Time frame: Baseline and 3-, 6-, 9-, and 12-month follow-up]
- Infant Heart Rate [Time frame: Baseline and 3-, 6-, 9-, and 12-month follow-up]
- Infant Respiratory Sinus Arrhythmia [Time frame: Baseline and 3-, 6-, 9-, and 12-month follow ups]
Secondary outcome measures (1)
- Infant social-emotional problems [Time frame: Baseline and 3-, 6-, 9-, and 12-month follow-ups]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
United States · 1 center
- Binghamton University — Binghamton
Identifiers
NCT: NCT06835855 · STUDY00004999 · R01MH132667