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COMPLETED NA

Social Circumstances, Parenting Techniques, and Infant Development

NCT02121496 · View on ClinicalTrials.gov ↗

Study Summary

1. Investigators aim to assess a novel behavioral intervention (currently approved in Protocol #6285) behavioral intervention that promotes maternally-mediated behavioral changes in young infants to reduce the risk of postpartum depression in a group of low income women. More specifically, investigators aim 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 in low socioeconomic status (SES) women, and (2) improve the quality of mother-infant interaction and subsequent child development. Investigators will study: 1. The feasibility of applying this protocol with a low SES population 2. The effectiveness of the intervention compared to usual care 3. If the effects of the intervention can be detected in assessments of the quality of mother-infant interaction and infant neurocognitive development 2. Investigators aim to determine whether this behavioral intervention can affect infant development as measured by neurodevelopmental assessments and cortisol reactivity at 4 months of age.

Interventions

  • BEHAVIORAL Resources for Postpartum Parenting

Study Locations (1)

New York

  • Columbia University Medical Center — New York

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2014-03
Est. Completion 2019-12
Phase NA

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02121496

The ClinicalTrials.gov registry entry for NCT02121496 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is New York State Psychiatric Institute, which has 117 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 3 conditions, with Postpartum Depression appearing as the primary indexed condition, and to 1 intervention — of which Resources for Postpartum Parenting is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02121496 reports 1 study location spanning 1 distinct geographic area — top geographies include New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT02121496 about?

NCT02121496 is a clinical study titled "Social Circumstances, Parenting Techniques, and Infant Development". 1. Investigators aim to assess a novel behavioral intervention (currently approved in Protocol #6285) behavioral intervention that promotes maternally-mediated behavioral changes in young infants to reduce the risk of postpartum depression in a group of low income women. More specifically, investiga...

What is the current status of trial NCT02121496?

This trial is currently completed. It is a NA study. The enrollment target is 60 participants. The study started on 2014-03. Estimated completion is 2019-12.

What conditions does trial NCT02121496 study?

This clinical trial studies the following conditions: Postpartum Depression, Infant Development, Rhythm; Sleep. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02121496?

The interventions under investigation include: Resources for Postpartum Parenting (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02121496?

This trial is sponsored by New York State Psychiatric Institute, which has 117 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT02121496 being conducted?

This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial