Preventing perinatal depression in individuals with childhood adversity
Prevention of Perinatal Depression in Birthing People With a History of Adverse Childhood Experiences: A Type 2 Effectiveness Implementation Trial
This study is testing a new support program to see if it can help pregnant people with tough childhood experiences avoid depression during and after pregnancy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 76 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Northwestern University Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT05795114 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of the ROSE intervention, designed for individuals with adverse childhood experiences, in preventing perinatal depression. Participants will be randomly assigned to receive either enhanced treatment as usual or the ROSE intervention, which is delivered by a care manager within a collaborative care model. Throughout the trial, participants will complete self-reported surveys every four weeks to track their depressive symptoms and undergo clinical interviews to identify any major depressive episodes. The study aims to determine how effectively the collaborative care model can mitigate the risk of perinatal depression among pregnant individuals with a history of adverse childhood experiences.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant individuals over 18 years old with a history of adverse childhood experiences and less than 24 weeks gestation.
Not a fit: Patients who are actively experiencing a major depressive episode or have a substance use disorder may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce the incidence of perinatal depression in at-risk populations.
How similar studies have performed: While the approach of using a collaborative care model for perinatal depression is promising, this specific intervention has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Chicago, Illinois
- Northwestern Medicine — Chicago, Illinois, United States (Recruiting)
Study contacts
- Study coordinator: Emily S Miller, MD, MPH
- Email: EmMiller@wihri.org
- Phone: 401-274-1122
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.