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Active Not Recruiting
NCT05795114
Perinatal Depression and Adverse Childhood Experiences: Prevention Trial
Conditions: Perinatal Depression
Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 76
Sponsor: Northwestern University
Location: Northwestern Medicine Chicago Illinois
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 Criteria
Inclusion 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
Exclusion Criteria:
* 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
Source: ClinicalTrials.gov (NCT05795114). StuddyBuddy aggregates publicly available trial information.