Prevention of Perinatal Depression in Birthing People With a History of Adverse Childhood Experiences: A Type 2 Effectiveness Implementation Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Northwestern University
- Enrollment
- 76
- Locations
- 1
- Primary Endpoint
- Perinatal depression
Study Overview
Brief 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.
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
ROSE intervention
Those randomized to the intervention will be offered 4 prenatal sessions and one 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.
Intervention: Reach Out, Stand Strong, Essentials for New Mothers (ROSE) Program (Behavioral)
Outcomes
Primary Outcomes
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
Depression symptoms
Time Frame: Up to 6 months postpartum
Depression symptom trajectories will be measured via Patient Health Questionnaire-9 (PHQ-9) screens administered
Secondary Outcomes
- Emotional support(Up to 6 months postpartum)
- Breastfeeding self-efficacy scale(Up to 6 months postpartum)
- Generalized anxiety disorder(Up to 6 months postpartum)
- Attachment in adult relationships(Up to 6 months postpartum)
- Anxiety symptoms(Up to 6 months postpartum)
- General self-efficacy(Up to 6 months postpartum)
- Parenting self-efficacy(Up to 6 months postpartum)
- Perceived stress symptoms(Up to 6 months postpartum)
- Post-traumatic stress disorder(Up to 6 months postpartum)
Investigators
Emily Miller
Associate Professor
Women and Infants Hospital of Rhode Island