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

Inclusion Criteria7

  • 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

Exclusion Criteria4

  • 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

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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05795114


Related Trials