Clinical trial NCT05795114: Perinatal Depression and Adverse Childhood Experiences: Prevention Trial
Official title: Prevention of Perinatal Depression in Birthing People With a History of Adverse Childhood Experiences: A Type 2 Effectiveness Implementation Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Perinatal Depression
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Women and Infants Hospital of Rhode Island
First posted: 2023-04-03
Enrollment: 76
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Depression symptoms
timeFrame: Up to 6 months postpartum
measure: Perinatal depression
timeFrame: Up to 6 months postpartum
Secondary outcomes:
measure: Anxiety symptoms
timeFrame: Up to 6 months postpartum
measure: Generalized anxiety disorder
timeFrame: Up to 6 months postpartum
measure: Post-traumatic stress disorder
timeFrame: Up to 6 months postpartum
measure: Perceived stress symptoms
timeFrame: Up to 6 months postpartum
measure: General self-efficacy
timeFrame: Up to 6 months postpartum
measure: Parenting self-efficacy
timeFrame: Up to 6 months postpartum
measure: Breastfeeding self-efficacy scale
timeFrame: Up to 6 months postpartum
measure: Attachment in adult relationships
timeFrame: Up to 6 months postpartum
measure: Emotional support
timeFrame: Up to 6 months postpartum
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Medicine
state: Illinois
Study officials:
References: