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NCT Number: NCT05795114

Perinatal Depression and Adverse Childhood Experiences: Prevention 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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Perinatal Depression

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern Medicine

Chicago, Illinois, 60611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Behavioral

A 5-part interpersonal therapy based intervention

Primary outcomes

  1. Depression symptoms

    Time frame: Up to 6 months postpartum

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

  2. Perinatal depression

    Time frame: Up to 6 months postpartum

    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

Secondary outcomes

  1. Anxiety symptoms

    Time frame: Up to 6 months postpartum

    Anxiety symptom trajectories will be measured via Generalized Anxiety Disorder-7 (GAD-7) screens administered every 4 weeks from enrollment until 6 months postpartum.

  2. Generalized anxiety disorder

    Time frame: Up to 6 months postpartum

    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.

  3. Post-traumatic stress disorder

    Time frame: Up to 6 months postpartum

    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.

  4. Perceived stress symptoms

    Time frame: Up to 6 months postpartum

    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

  5. General self-efficacy

    Time frame: Up to 6 months postpartum

    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

  6. Parenting self-efficacy

    Time frame: Up to 6 months postpartum

    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

  7. Breastfeeding self-efficacy scale

    Time frame: Up to 6 months postpartum

    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

  8. Attachment in adult relationships

    Time frame: Up to 6 months postpartum

    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.

  9. Emotional support

    Time frame: Up to 6 months postpartum

    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.

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • Women and Infants Hospital of Rhode Island

Registry information

Official study title

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

Acronym: PPD-ACE

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Apr 3, 2023
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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