Perinatal Depression and Adverse Childhood Experiences: Prevention Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-20

Study Completion Date

2026-01-31

Brief Summary

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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.

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Detailed Description

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The salience of early life experiences during the transition to parenthood underscores the risk of perinatal depression for those with childhood adversity. Mitigation of the adverse effects of childhood adversity via prevention of perinatal depression is an essential component of a reproductive justice-focused public health strategy. Whether and how the collaborative care model can be most effectively leveraged to prevent perinatal depression among pregnant people with a history of ACEs is unknown. To answer these questions, investigators propose a randomized clinical trial of trauma-informed interpersonal therapy modeled after the ROSE intervention and embedded within a perinatal collaborative care program utilizing a type 2 hybrid effectiveness-implementation design.

Conditions

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Perinatal Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Enhanced treatment as usual

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

ROSE intervention

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.

Group Type EXPERIMENTAL

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

Intervention Type BEHAVIORAL

A 5-part interpersonal therapy based intervention

Interventions

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

A 5-part interpersonal therapy based intervention

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No