Reducing Stress-Sensitive Problems Among Pregnant Black Women With Childhood Adversity: A Pilot Randomized Controlled Trial of Motivational Interviewing and Mental Wellness Skills
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change in Edinburgh Postnatal Depression Scale at 2-months post-intervention
研究概览
简要总结
The goal of this clinical trial is to test the feasibility and acceptability and compare outcomes of a trauma-informed prenatal intervention (TPI) in pregnant Black women with childhood adversity. TPI participants will receive four weekly individual virtual sessions of motivational interviewing to promote self-efficacy and mental wellness skills to enhance self-awareness and self-regulation. TPI is designed to foster behavior change and health coping by enhancing knowledge, beliefs, regulation skills and abilities.
- With the assistance of a trained facilitator, participants will be guided to identify a specific goal related to the behavior they want to change.
- Behavior change goals will be individualized to create a change plan that reinforces resilience-based coping, accountability, and self-care rewards.
- Participants will learn to apply mental wellness skills to enhance regulation and to facilitate awareness of internal cues related to desire, motivation, and individual responses to stress.
Researchers will compare usual prenatal care plus TPI versus usual prenatal care plus prenatal education to see if TPI reduces psychological (e.g., depression, anxiety, and perceived stress), and socio-emotional (e.g., mood, resilience, social support), and prenatal health behaviors.
详细描述
The goal of this research to reduce the impact of maternal adverse childhood experiences (ACEs) on perinatal mental and psychosocial health by providing the necessary tools for the development of healthy coping practices. The purpose of this proposal is to conduct Phase II preliminary testing of an individually randomized pilot trial (N=40) examining feasibility, acceptability, and compare initial estimates of the effects of the primary outcome of depression and secondary outcomes of psychological (e.g., stress and anxiety) and socio-emotional (e.g., mood, resilience, social support) functioning and prenatal health behaviors of those allocated to either a trauma-informed prenatal intervention (TPI) (n=15) or the control group, e.g., prenatal education arm, (n=15). Forty adult, pregnant women receiving prenatal care at one large Federally Qualified Health Center will be enrolled between 10-24 weeks gestation. TPI participants will receive four weekly (30-60 minute) individual online sessions of motivational interviewing to facilitate behavior change and mental wellness skills to promote self-regulation. Control group participants will receive four weekly (30-60 minutes) individual online sessions of prenatal education. Patient-reported outcome measures will be interview-administered at baseline, 4- and 12-weeks post-randomization, and 6-weeks postpartum. A trauma-informed approach within prenatal care services may help reduce maternal distress and its consequences, and, subsequently, lessen the risk for the negative impact of ACEs on maternal and child health. Findings from this study will inform a larger efficacy trial of TPI to improve perinatal mental health among pregnant women.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •receiving prenatal care at University of Illinois Health & Hospital System
- •age >/= 18 years
- •English-speaking
- •10-24 weeks gestation
- •able to attend four sessions
- •owner of a smart phone and access to internet
排除标准
- •inability to reliably or safely participate in the study due to self-reported serious or persistent mental health disorder (e.g., schizophrenia or bipolar disorder), which could also interfere with study adherence.
结局指标
主要结局
Change in Edinburgh Postnatal Depression Scale at 2-months post-intervention
时间窗: 6-weeks postnatal
The Edinburgh Postnatal Depression Scale (range: 0-30) is a 10-item scale is a pregnancy and/or postpartum depression screen that assesses different emotions in the past seven days in which a higher score indicates a worse outcome.
次要结局
- Change in Perceived Stress Scale at 2-months post-intervention(6-weeks postnatal)
- Negative Mood Regulation Short Form Scale at 2-months post-intervention(6-weeks postnatal)
- Connor Davidson Resilience Scale at 2-months post-intervention(6-weeks postpartum)
- Change in Generalized Anxiety Disorder Scale at 2-months post-intervention(6-weeks postnatal)
- Change in Behavioral Activation Scale at 2-months post-intervention(6-weeks postnatal)
- Prenatal Health Behaviors at 2-months post-intervention(6-weeks postnatal)
- Multidimensional Scale of Perceived Social Support at 2-months post-intervention(6-weeks postpartum)
研究者
Ellen Goldstein
Assistant Professor
University of Illinois at Chicago