NCT05795114

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
5mo left

Started Jul 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress89%
Jul 2023Oct 2026

First Submitted

Initial submission to the registry

March 10, 2023

Completed
24 days until next milestone

First Posted

Study publicly available on registry

April 3, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

July 20, 2023

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2026

Last Updated

May 18, 2026

Status Verified

May 1, 2026

Enrollment Period

3.3 years

First QC Date

March 10, 2023

Last Update Submit

May 15, 2026

Conditions

Perinatal Depression

Outcome Measures

Primary Outcomes (2)

  • Depression symptoms

    Depression symptom trajectories will be measured via Patient Health Questionnaire-9 (PHQ-9) screens administered

    Up to 6 months postpartum

  • Perinatal depression

    Perinatal depression includes any categorical diagnosis of a major depressive episode, assessed using the Longitudinal Interval Follow-Up Examination measured by trained research personnel masked to the intervention

    Up to 6 months postpartum

Secondary Outcomes (9)

  • Anxiety symptoms

    Up to 6 months postpartum

  • Generalized anxiety disorder

    Up to 6 months postpartum

  • Post-traumatic stress disorder

    Up to 6 months postpartum

  • Perceived stress symptoms

    Up to 6 months postpartum

  • General self-efficacy

    Up to 6 months postpartum

  • +4 more secondary outcomes

Study Arms (2)

Enhanced treatment as usual

NO INTERVENTION

Those randomized to enhanced treatment as usual will receive brief psychoeducation about perinatal depression and the associations between ACEs and perinatal depression. Information about the collaborative care program will be provided. Individuals will be followed with monthly self-reported screens for depression, without any prevention programming for perinatal depression. Those identified to have incident depression symptoms will receive recommendations for treatment within the collaborative care model.

ROSE intervention

EXPERIMENTAL

Those randomized to the intervention will be offered 4 group-based prenatal sessions and one individual postpartum "booster" session guided by the Reach Out, Stand Strong, Essentials for New Mothers (ROSE) program embedded within the collaborative care model. Participants will be followed with monthly self-reported screens for depression, and those identified to have incident depression symptoms will receive treatment within the collaborative care model.

Behavioral: Reach Out, Stand Strong, Essentials for New Mothers (ROSE) Program

Interventions

Reach Out, Stand Strong, Essentials for New Mothers (ROSE) ProgramBEHAVIORAL

A 5-part interpersonal therapy based intervention

ROSE intervention

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern Medicine

Chicago, Illinois, 60611, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 10, 2023

First Posted

April 3, 2023

Study Start

July 20, 2023

Primary Completion (Estimated)

October 31, 2026

Study Completion (Estimated)

October 31, 2026

Last Updated

May 18, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)