Perinatal Depression and Adverse Childhood Experiences: Prevention Trial

Study Overview
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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.

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.

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

Conditions
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Perinatal Depression

Intervention / Treatment
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* Behavioral: Reach Out, Stand Strong, Essentials for New Mothers (ROSE) Program


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Enhanced treatment as usual<br>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. | |
| Experimental: ROSE intervention<br>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<br>* A 5-part interpersonal therapy based intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety symptoms | Anxiety symptom trajectories will be measured via Generalized Anxiety Disorder-7 (GAD-7) screens administered every 4 weeks from enrollment until 6 months postpartum. | Up to 6 months postpartum | 
| Generalized anxiety disorder | Generalized anxiety disorder includes any categorical diagnosis of generalized anxiety disorder, assessed using the Longitudinal Interval Follow-Up Examination measured by trained research personnel masked to the intervention in the 3rd trimester, at 3 months postpartum, and at 6 months postpartum. | Up to 6 months postpartum | 
| Post-traumatic stress disorder | Post-traumatic stress disorder includes any categorical diagnosis of a post-traumatic stress disorder, assessed using the Longitudinal Interval Follow-Up Examination measured by trained research personnel masked to the intervention in the 3rd trimester, at 3 months postpartum, and at 6 months postpartum. | Up to 6 months postpartum | 
| Perceived stress symptoms | Stress symptom trajectories will be measured via Perceived Stress Scale (PSS) screens administered every 4 weeks from enrollment until 6 months postpartum. Minimum value: 0 Maximum value: 40 Higher scores indicate a worse outcome | Up to 6 months postpartum | 
| General self-efficacy | Self-efficacy will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Self-Efficacy scale, administered in the 3rd trimester, at 3 months postpartum, and at 6 months postpartum. Minimum value: 10 Maximum value: 50 Higher scores indicate a better outcome | Up to 6 months postpartum | 
| Parenting self-efficacy | Parenting self-efficacy will be measured with the Parenting Sense of Competence scale administered in the 3rd trimester, at 3 months postpartum, and at 6 months postpartum. Minimum value: 17 Maximum value: 102 Higher scores indicate a better outcome | Up to 6 months postpartum | 
| Breastfeeding self-efficacy scale | Breastfeeding self-efficacy will be measured with the Breastfeeding Self-Efficacy scale administered in the 3rd trimester, at 3 months postpartum, and at 6 months postpartum. Included are individuals who are breastfeeding at each of the assessed time-points. Minimum value: 14 Maximum value: 70 Higher scores indicate a better outcome | Up to 6 months postpartum | 
| Attachment in adult relationships | Attachment in adult relationships will be measured with the Experiences in Close Relationships-Revised Questionnaire administered in the 3rd trimester, at 3 months postpartum, and at 6 months postpartum. | Up to 6 months postpartum | 
| Emotional support | Emotional support will be measured with the PROMIS Emotional Support-Short Form administered in the 3rd trimester, at 3 months postpartum, and at 6 months postpartum. | Up to 6 months postpartum |