Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
NCT05795114

Perinatal Depression and Adverse Childhood Experiences: Prevention Trial

Led by Northwestern University · Updated on 2025-02-28

76

Participants Needed

1

Research Sites

132 weeks

Total Duration

On this page

Sponsors

N

Northwestern University

Lead Sponsor

W

Women and Infants Hospital of Rhode Island

Collaborating Sponsor

AI-Summary

What this Trial Is About

The goal of this clinical trial is to evaluate the impact of ROSE in individuals with adverse childhood experiences. The main question it aims to answer is, compared to enhanced treatment as usual, does the delivery of ROSE within a collaborative care model improve depressive symptom trajectories and prevent the development of perinatal depression. Participants will be randomized to either enhanced treatment as usual or the ROSE intervention, delivered by a care manager within a perinatal collaborative care program. They will complete self-reported surveys of their depression symptoms every 4 weeks to inform their symptom trajectories. They will also complete clinical interviews to establish any incident diagnoses of a major depressive episode.

CONDITIONS

Official Title

Perinatal Depression and Adverse Childhood Experiences: Prevention Trial

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • At least one prenatal visit at Northwestern Medicine
  • Less than 24 weeks gestation
  • Non-anomalous pregnancy
  • English- or Spanish-speaking
  • ACE score of 2 or higher
  • Singleton pregnancy
Not Eligible

You will not qualify if you...

  • Plan to deliver outside of Prentice Women's Hospital
  • Active major depressive episode
  • Active substance use disorder
  • Currently participating in a study with a competing intervention or outcome

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Trial Site Locations

Total: 1 location

1

Northwestern Medicine

Chicago, Illinois, United States, 60611

Actively Recruiting

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Research Team

E

Emily S Miller, MD, MPH

CONTACT

S

Sheehan Fisher, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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