Perinatal Depression and Adverse Childhood Experiences: Prevention Trial

Description

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

Perinatal Depression

Study Overview

Study Details

Study overview

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.

Prevention of Perinatal Depression in Birthing People With a History of Adverse Childhood Experiences: A Type 2 Effectiveness Implementation Trial

Perinatal Depression and Adverse Childhood Experiences: Prevention Trial

Condition
Perinatal Depression
Intervention / Treatment

-

Contacts and Locations

Chicago

Northwestern Medicine, Chicago, Illinois, United States, 60611

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Age ≥ 18 years
  • * At least one prenatal visit at Northwestern Medicine
  • * Less than 24 weeks gestation
  • * Non-anomalous pregnancy
  • * English- or Spanish- speaking
  • * ACE score ≥ 2
  • * Singleton gestation
  • * Intent to delivery outside of Prentice Women's Hospital
  • * Active major depressive episode
  • * Active substance use disorder
  • * Participation in a study with a competing intervention or outcome

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Northwestern University,

Study Record Dates

2025-08-31