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NCT05718479 · ClinicalTrials.gov registry record · NA

Reducing Stress-Sensitive Problems Among Pregnant Black Women With Childhood Adversity

A NA study, sponsored by University of Illinois at Chicago.

Completed
Registry status
NA
Development phase
40
Enrollment target

NCT05718479: Completed NA study, sponsored by University of Illinois at Chicago.

NCT05718479 is a NA study that has completed, run by University of Illinois at Chicago. The registered enrollment target is 40 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05718479, a NA study, has completed, sponsored by University of Illinois at Chicago.

COMPLETED
Registry status
NA
Development phase
40 participants
Enrollment target

Study Summary

The goal of this clinical trial is to test the feasibility and acceptability and compare outcomes of a trauma-informed prenatal intervention (TPI) in pregnant Black women with childhood adversity. TPI participants will receive four weekly individual virtual sessions of motivational interviewing to promote self-efficacy and mental wellness skills to enhance self-awareness and self-regulation. TPI is designed to foster behavior change and health coping by enhancing knowledge, beliefs, regulation skills and abilities. * With the assistance of a trained facilitator, participants will be guided to identify a specific goal related to the behavior they want to change. * Behavior change goals will be individualized to create a change plan that reinforces resilience-based coping, accountability, and self-care rewards. * Participants will learn to apply mental wellness skills to enhance regulation and to facilitate awareness of internal cues related to desire, motivation, and individual responses to stress. Researchers will compare usual prenatal care plus TPI versus usual prenatal care plus prenatal education to see if TPI reduces psychological (e.g., depression, anxiety, and perceived stress), and socio-emotional (e.g., mood, resilience, social support), and prenatal health behaviors.

Primary Outcome

The Edinburgh Postnatal Depression Scale (range: 0-30) is a 10-item scale is a pregnancy and/or postpartum depression screen that assesses different emotions in the past seven days in which a higher score indicates a worse outcome.

Interventions

  • BEHAVIORAL Trauma Informed Prenatal Intervention (TPI)
  • OTHER Prenatal Education Topics

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2023-02-14
Est. Completion 2024-03-01
Phase NA
University of Illinois at Chicago

430 total trials

What the finished NCT05718479 record still lists

NCT05718479 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).

The record links to 0 conditions, and to 2 interventions - of which Trauma Informed Prenatal Intervention (TPI) is the first listed.

NCT05718479 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05718479 about?

NCT05718479 is a clinical study titled "Reducing Stress-Sensitive Problems Among Pregnant Black Women With Childhood Adversity". The goal of this clinical trial is to test the feasibility and acceptability and compare outcomes of a trauma-informed prenatal intervention (TPI) in pregnant Black women with childhood adversity. TPI participants will receive four weekly individual virtual sessions of motivational interviewing to p...

What is the current status of trial NCT05718479?

This trial is currently completed. It is a NA study. The enrollment target is 40 participants. The study started on 2023-02-14. Estimated completion is 2024-03-01.

What interventions are being tested in trial NCT05718479?

The interventions under investigation include: Trauma Informed Prenatal Intervention (TPI) (BEHAVIORAL), Prenatal Education Topics (OTHER).

Who is sponsoring clinical trial NCT05718479?

This trial is sponsored by University of Illinois at Chicago, which has 430 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT05718479's enrollment target sits among peer trials

40 1447th of 2000 higher than 465 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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Source: ClinicalTrials.gov NCT05718479, the US trial registry maintained by the National Library of Medicine. NCT05718479 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.