RecruitingNot ApplicableNCT05795114

Perinatal Depression and Adverse Childhood Experiences: Prevention Trial

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


Sponsor

Northwestern University

Enrollment

76 participants

Start Date

Jul 20, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a program designed to prevent depression during and after pregnancy in women who have experienced significant childhood adversity (such as abuse, neglect, or household dysfunction). **You may be eligible if...** - You are 18 or older - You are pregnant at less than 24 weeks - You have had at least one prenatal visit at Northwestern Medicine - You speak English or Spanish - You have a score of 2 or higher on the ACE (Adverse Childhood Experiences) questionnaire - You are carrying a single baby with no known abnormalities **You may NOT be eligible if...** - You plan to deliver outside of Prentice Women's Hospital - You are currently experiencing a major depressive episode - You have an active substance use disorder - You are already participating in another study with a competing intervention Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALReach Out, Stand Strong, Essentials for New Mothers (ROSE) Program

A 5-part interpersonal therapy based intervention


Locations(1)

Northwestern Medicine

Chicago, Illinois, United States

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NCT05795114


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