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NCT03283254 · ClinicalTrials.gov registry record · NA
PREPP: Preventing Postpartum Depression
A NA study, sponsored by Columbia University.
- Completed
- Registry status
- NA
- Development phase
- 216
- Enrollment target
NCT03283254: Completed NA study, sponsored by Columbia University.
NCT03283254 is a NA study that has completed, run by Columbia University. The registered enrollment target is 216 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03283254, a NA study, has completed, sponsored by Columbia University.
- COMPLETED
- Registry status
- NA
- Development phase
- 216 participants
- Enrollment target
Study Summary
The primary aim of this study is to determine if a behavioral intervention targeting maternal caregiving of young infants can increase infant sleep and reduce fuss/cry behavior, and thereby (1) reduce the incidence and/or severity of postpartum maternal depression and (2) improve the quality of the mother-infant interaction and subsequent child development. Specifically, the study team will investigate: (1) the effectiveness of the intervention compared to usual care; (2) if the effects of the intervention can be detected in the assessments of the quality of mother-infant interaction; (3) if there are prenatal and/or postnatal biomarkers that can help identify infants whose behavior is more likely to play a role in their mothers' depression; (4) if these markers differentiate which infants will be most responsive to the intervention(s); and (5), if assessments of brain function at birth and at 4-6 weeks of age provide biological nodal points for identifying the effects of the intervention on infant brain development. Participants will be recruited during their 2nd trimester, and will be randomly separated into one of two groups: a group that receives coaching in parenting techniques 3 coaching sessions and 2 check-in sessions or one that receives treatment as usual.
Primary Outcome
Maternal mood: Postpartum Depression Symptoms will be measured by Edinburgh Postnatal Depression Scale (EPDS). The EPDS is a 10-item questionnaire that was developed to identify women who have postpartum depression. Items of the scale correspond to various clinical depression symptoms, such as guilt feeling, sleep disturbance, low energy, anhedonia, and suicidal ideation. Overall assessment is done by total score, which is determined by adding together the scores for each of the 10 items. Scores
Interventions
- BEHAVIORAL Practical Resources for Effective Postpartum Parenting (PREPP)
- BEHAVIORAL Enhanced Treatment As Usual (ETAU)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 216 participants |
| Start Date | 2018-02-12 |
| Est. Completion | 2024-02-28 |
| Phase | NA |
What the finished NCT03283254 record still lists
NCT03283254 is an interventional study that assigns participants to a tested intervention. The registered 216 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 2 interventions - of which Practical Resources for Effective Postpartum Parenting (PREPP) is the first listed.
NCT03283254 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03283254 about?
NCT03283254 is a clinical study titled "PREPP: Preventing Postpartum Depression". The primary aim of this study is to determine if a behavioral intervention targeting maternal caregiving of young infants can increase infant sleep and reduce fuss/cry behavior, and thereby (1) reduce the incidence and/or severity of postpartum maternal depression and (2) improve the quality of the ...
What is the current status of trial NCT03283254?
This trial is currently completed. It is a NA study. The enrollment target is 216 participants. The study started on 2018-02-12. Estimated completion is 2024-02-28.
What interventions are being tested in trial NCT03283254?
The interventions under investigation include: Practical Resources for Effective Postpartum Parenting (PREPP) (BEHAVIORAL), Enhanced Treatment As Usual (ETAU) (BEHAVIORAL).
Who is sponsoring clinical trial NCT03283254?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03283254's enrollment target sits among peer trials
216 485th of 2000 higher than 1,514 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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