Perinatal Depression and Adverse Childhood Experiences: Prevention Trial — PPD-ACE  

Perinatal Depression Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

The salience of early life experiences during the transition to parenthood underscores the risk of perinatal depression for those with childhood adversity. Mitigation of the adverse effects of childhood adversity via prevention of perinatal depression is an essential component of a reproductive justice-focused public health strategy. Whether and how the collaborative care model can be most effectively leveraged to prevent perinatal depression among pregnant people with a history of ACEs is unknown. To answer these questions, investigators propose a randomized clinical trial of trauma-informed interpersonal therapy modeled after the ROSE intervention and embedded within a perinatal collaborative care program utilizing a type 2 hybrid effectiveness-implementation design. ;

Related Conditions & MeSH terms

• Asphyxia Neonatorum
• Depression
• Depressive Disorder
• Perinatal Depression

• NCT number: NCT05795114
• Study type: Interventional
• Source: Northwestern University
• Contact: Emily S Miller, MD, MPH
• Phone: 401-274-1122
• Email: EmMiller@wihri.org
• Status: Recruiting
• Phase: N/A
• Start date: July 20, 2023
• Completion date: August 31, 2025