Perinatal Depression
Conditions
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.
Interventions
BEHAVIORALReach Out, Stand Strong, Essentials for New Mothers (ROSE) Program
A 5-part interpersonal therapy based intervention
Sponsors
Northwestern University
Women and Infants Hospital of Rhode Island
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Depression symptoms | Up to 6 months postpartum | Depression symptom trajectories will be measured via Patient Health Questionnaire-9 (PHQ-9) screens administered |
| Perinatal depression | 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
| Measure | Time frame | Description |
|---|---|---|
| Anxiety symptoms | 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. |
| Generalized anxiety disorder | 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. |
| Post-traumatic stress disorder | 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. |
| Perceived stress symptoms | 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 |
| General self-efficacy | 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 |
| Parenting self-efficacy | 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 |
| Breastfeeding self-efficacy scale | 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 |
| Attachment in adult relationships | 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. |
| Emotional support | 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. |
Countries
United States
Outcome results
None listed