NCT05795114

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 76 (estimated)
• Sponsor: Northwestern University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Perinatal Depression

Interventions

Type	Name	Description
BEHAVIORAL	Reach Out, Stand Strong, Essentials for New Mothers (ROSE) Program	A 5-part interpersonal therapy based intervention

Timeline

• Start date: 2023-07-20
• Primary completion: 2025-09-01
• Completion: 2026-01-31
• First posted: 2023-04-03
• Last updated: 2025-02-28

Locations

1 site across 1 country: United States