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

NCT06835855 · Binghamton University
In plain English

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About this study
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.
Study design
Enrollment target: 225 participants
Allocation: na
Masking: none
Age groups: child, adult, older_adult
Timeline
Starts: 2024-11-14
Estimated completion: 2029-07
Last updated: 2025-02-20
Interventions
Other: Passive Viewing TaskOther: Interaction Task
Primary outcomes
  • Eye gaze during computer-based task (Baseline and 3-, 6-, 9-, and 12-month follow-up)
  • Eye gaze during the interaction task (Baseline and 3-, 6-, 9-, and 12-month follow-up)
  • Infant Heart Rate (Baseline and 3-, 6-, 9-, and 12-month follow-up)
Sponsor
Binghamton University · other
With: National Institute of Mental Health (NIMH)
Contacts & investigators
ContactBrandon E Gibb, Ph.D. · contact · bgibb@binghamton.edu · 607-777-2511
All locations (1)
Binghamton UniversityRecruiting
Binghamton, New York, United States
Development of Attentional Biases for Affective Cues in Infants of Mothers With Depression · TrialPath