Perinatal Depression and Adverse Childhood Experiences: Prevention Trial

Perinatal Depression Clinical Trial

— PPD-ACE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05795114
• Other study ID #: STU00217940
• Status: Recruiting
• Phase: N/A
• Start date: July 20, 2023
• Est. completion date: August 31, 2025

Study information

• Verified date: September 2023
• Source: Northwestern University
• Contact: Emily S Miller, MD, MPH
• Phone: 401-274-1122
• Email: EmMiller[@]wihri.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 76
• Est. completion date: August 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asphyxia Neonatorum
• Depression
• Depressive Disorder
• Perinatal Depression

Intervention

Behavioral:
• Reach Out, Stand Strong, Essentials for New Mothers (ROSE) Program
A 5-part interpersonal therapy based intervention

Locations

Country	Name	City	State
United States	Northwestern Medicine	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	Women and Infants Hospital of Rhode Island

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depression symptoms	Depression symptom trajectories will be measured via Patient Health Questionnaire-9 (PHQ-9) screens administered	Up to 6 months postpartum
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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