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.
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
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
76
A 5-part interpersonal therapy based intervention
Northwestern Medicine
Chicago, Illinois, United States
Depression symptoms
Depression symptom trajectories will be measured via Patient Health Questionnaire-9 (PHQ-9) screens administered
Time frame: 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
Time frame: Up to 6 months postpartum
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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: Up to 6 months postpartum
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