RECRUITING

Perinatal Depression and Adverse Childhood Experiences: Prevention Trial

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-07-20
Study Completion:2025-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05795114

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age ≥ 18 years
  2. * At least one prenatal visit at Northwestern Medicine
  3. * Less than 24 weeks gestation
  4. * Non-anomalous pregnancy
  5. * English- or Spanish- speaking
  6. * ACE score ≥ 2
  7. * Singleton gestation
  1. * Intent to delivery outside of Prentice Women's Hospital
  2. * Active major depressive episode
  3. * Active substance use disorder
  4. * Participation in a study with a competing intervention or outcome

Contacts and Locations

Study Contact

Emily S Miller, MD, MPH
CONTACT
401-274-1122
EmMiller@wihri.org
Sheehan Fisher, PhD
CONTACT
sheehan.fisher@northwestern.edu

Study Locations (Sites)

Northwestern Medicine
Chicago, Illinois, 60611
United States

Collaborators and Investigators

Sponsor: Northwestern University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-07-20
Study Completion Date2025-08-31

Study Record Updates

Study Start Date2023-07-20
Study Completion Date2025-08-31

Terms related to this study

Additional Relevant MeSH Terms

  • Perinatal Depression