Perinatal Depression and Adverse Childhood Experiences: Prevention Trial (PPD-ACE)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Perinatal Depression
• Intervention / Treatment: Behavioral: Reach Out, Stand Strong, Essentials for New Mothers (ROSE) Program

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 76
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Emily S Miller, MD, MPH; Phone Number: 47452 401-274-1122; Email: EmMiller@wihri.org
• Study Contact Backup: Name: Sheehan Fisher, PhD; Email: sheehan.fisher@northwestern.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • Northwestern Medicine
      • Contact: Sheehan Fisher, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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.
Experimental: 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.	Behavioral: Reach Out, Stand Strong, Essentials for New Mothers (ROSE) Program; A 5-part interpersonal therapy based intervention

What is the study measuring?

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
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
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

Collaborators and Investigators

• Sponsor: Northwestern University
• Collaborators: Women and Infants Hospital of Rhode Island

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): August 31, 2025

Study Registration Dates

• First Submitted: March 10, 2023
• First Submitted That Met QC Criteria: March 31, 2023
• First Posted (Actual): April 3, 2023

Study Record Updates

• Last Update Posted (Actual): September 13, 2023
• Last Update Submitted That Met QC Criteria: September 11, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Infant, Newborn, Diseases; Depression; Depressive Disorder; Asphyxia Neonatorum
• Other Study ID Numbers: STU00217940

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No