Prevention of Perinatal Depression in Birthing People With a History of Adverse Childhood Experiences: A Type 2 Effectiveness Implementation Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- Perinatal depression
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Reach Out, Stand Strong, Essentials for New Mothers (ROSE) Program (Behavioral)
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.
结局指标
主要结局
Perinatal depression
时间窗: 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
时间窗: Up to 6 months postpartum
Depression symptom trajectories will be measured via Patient Health Questionnaire-9 (PHQ-9) screens administered
次要结局
- 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)
- Emotional support(Up to 6 months postpartum)
研究者
Emily Miller
Associate Professor
Women and Infants Hospital of Rhode Island