Development of Attentional Biases for Affective Cues in Infants of Mothers With Depression (NCT06835855) | Clinical Trial Compass
RecruitingNot Applicable
Development of Attentional Biases for Affective Cues in Infants of Mothers With Depression
United States225 participantsStarted 2024-11-14
Plain-language 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.
Who can participate
Age range
6 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Eye gaze during computer-based task
Timeframe: Baseline and 3-, 6-, 9-, and 12-month follow-up
2
Eye gaze during the interaction task
Timeframe: Baseline and 3-, 6-, 9-, and 12-month follow-up
3
Infant Heart Rate
Timeframe: Baseline and 3-, 6-, 9-, and 12-month follow-up
4
Infant Respiratory Sinus Arrhythmia
Timeframe: Baseline and 3-, 6-, 9-, and 12-month follow ups