Recruiting

Observational Study

Sponsor:

Binghamton University

Code:

NCT06835855

Conditions

Depression - Major Depressive Disorder

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

Interventions

Passive Viewing Task

Interaction Task

Study Details

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

Study ID

NCT06835855

Start date

Nov 14, 2024

Status verified date

Feb, 2025

Completion date

Jul, 2029

Anticipated

Primary completion date

Feb, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

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

225 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Experimental protocol for all infants

Interventions

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.

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 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.

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Brandon E Gibb, Ph.D.

607-777-2511bgibb@binghamton.edu

Locations

Binghamton University

Recruiting

Binghamton, New York, United States, 13902

Contacts

Brandon E Gibb, Ph.D.

607-777-2511bgibb@binghamton.edu

Principal Investigator:

Brandon E Gibb, Ph.D.

More Information

Sponsor

Binghamton University

Last update posted

Feb 20, 2025

Last verified

Feb, 2025

Keywords

  • postpartum
  • infant
  • attention
  • psychophysiology

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-28. This information was provided to ClinicalTrials.gov by Binghamton University on 2025-02-20. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.