Depression - Major Depressive DisorderNCT06835855
Development of Attentional Biases for Affective Cues in Infants of Mothers With Depression
A study testing Passive Viewing Task and Interaction Task in people with Depression - Major Depressive Disorder, run by Binghamton University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months and olderHealthy volunteers can take part
- Conditions the study is for
- Depression - Major Depressive Disorder
- What is being tested?
- Passive Viewing Task and Interaction Task
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Nov 2024to Jul 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Binghamton University
Binghamton, New York, 13902
Brandon E Gibb, Ph.D., 607-777-2511, bgibb@binghamton.edu
Brandon E Gibb, Ph.D.
About this study
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.
Read the 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).
- Conditions
- Depression - Major Depressive Disorder
- Being tested
- Passive Viewing Task, Interaction Task
- Keywords
- postpartum, infant, attention, psychophysiology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Passive Viewing TaskOther
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 TaskOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental protocol for all infants | Experimental | Not described Receives: Other: Passive Viewing Task; Other: Interaction Task |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline and 3-, 6-, 9-, and 12-month follow-up
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)
Measured: Baseline and 3-, 6-, 9-, and 12-month follow-up
Infant Heart Rate
During the interaction tasks, the investigators will record infant electrocardiography (ECG) to calculate heart rate (HR) using a MindWare Mobile system.
Measured: Baseline and 3-, 6-, 9-, and 12-month follow-up
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.
Measured: 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.
Measured: Baseline and 3-, 6-, 9-, and 12-month follow-ups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2025
- Study start14 Nov 2024
- Primary completionFeb 2029 (estimated)
- Study completionJul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression - Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 225 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Binghamton University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06835855
- Sponsor's protocol ID
- STUDY00004999
- Other IDs
- R01MH132667
- Status last verified
- Sep 2026
- First submitted
- 17 Jan 2025
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data will be shared via the NIMH Data Archive (NDA). All data will be de-identified prior to submission to the repository, but the information needed to generate a global unique identifier for the NDA will be collected for each subject.
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Attentional Biases for Affective Cues in Infants of Mothers With Depression
- ClinicalTrials.gov ID
- NCT06835855
- Acronym / sponsor ID
- STUDY00004999
- Conditions
- Depression - Major Depressive Disorder
- Keywords
- postpartum, infant, attention, psychophysiology
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 225 participants (estimated)
- Lead sponsor
- Binghamton UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 14 Nov 2024 (actual)
- Primary completion
- Feb 2029 (estimated)
- Study completion
- Jul 2029 (estimated)
- First posted
- 19 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental protocol for all infants | Experimental | Other: Passive Viewing Task, Other: Interaction Task |
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Passive Viewing TaskInfants 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 | Experimental protocol for all infants |
| Interaction TaskMother 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. | Other | Experimental protocol for all infants |
Primary outcome
Eye gaze during computer-based task
Time frame: Baseline and 3-, 6-, 9-, and 12-month follow-up
Used to determine percent of infant attention allocated to each emotional stimulus type (angry, happy, sad, neutral) during the computer-based task
Eye gaze during the interaction task
Time frame: Baseline and 3-, 6-, 9-, and 12-month follow-up
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)
Infant Heart Rate
Time frame: Baseline and 3-, 6-, 9-, and 12-month follow-up
During the interaction tasks, the investigators will record infant electrocardiography (ECG) to calculate heart rate (HR) using a MindWare Mobile system.
Infant Respiratory Sinus Arrhythmia
Time frame: Baseline and 3-, 6-, 9-, and 12-month follow ups
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.
1 secondary outcome
Infant social-emotional problems
Time frame: Baseline and 3-, 6-, 9-, and 12-month follow-ups
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: Yes. Individual participant data will be shared via the NIMH Data Archive (NDA). All data will be de-identified prior to submission to the repository, but the information needed to generate a global unique identifier for the NDA will be collected for each subject.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Passive Viewing Task and Interaction Task in people with Depression - Major Depressive Disorder, run by Binghamton University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brandon E Gibb, Ph.D. (607-777-2511, bgibb@binghamton.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eye gaze during computer-based task (time frame: Baseline and 3-, 6-, 9-, and 12-month follow-up). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.