Promoting Healthy Brain Development Via Prenatal Stress Reduction: an Innovative Precision Medicine Approach
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Disruptive Behavior Diagnostic Observation Schedule (DB DOS)
研究概览
简要总结
The "Promoting Healthy Brain Project" (PHBP) is part of the Lurie Children's Hospital Strategic Research Initiative on Perinatal Origins of Childhood Disease: Research & Prevention at the Maternal-Fetal Interface. The overall purpose of the PHBP is to test whether reducing maternal stress during pregnancy is associated with improved neurodevelopment in the first year of life. This will be tested via a randomized controlled trial (n = 100) of a technology and mindfulness enhanced prenatal stress-reduction intervention (Mothers and Babies; MB).
详细描述
The "Promoting Healthy Brain Project" (PHBP) aims to improve infant neurodevelopmental trajectories by intervening on the fetal environment. The PHBP will experimentally test whether reducing prenatal maternal stress is associated with improved neurodevelopment in the first year of life. A randomized controlled trial (RCT) of a technology and mindfulness-enhanced prenatal maternal stress-reduction intervention (The Mothers and Babies Course; MB), compared to usual prenatal care. Prospective evaluation of infant neurodevelopmental outcomes will take place through infant age 24 months. Participants assigned to the intervention group will be offered the 12-session MB intervention, a well-studied intervention that will include new mindfulness practice enhancements designed to promote practice of awareness and attention to the present moment. MB visits will be delivered 1-on-1 by a trained facilitator in an open and nonjudgmental way, and will be offered in-person, over the phone, and/or by video chat. Throughout the intervention, all participants (intervention group and control group) will also wear a wireless, "smart" health sensing device (BioStamp Sensor - nPoint Device) that will measure heart rate and motion. Mothers' heart rate variability and self-reported stress and emotion will be monitored using the BioStamp Sensor and brief smartphone surveys. For mothers in the intervention group, patterns of prolonged stress will trigger a "just-in-time adapted intervention" (JITAI) that will be delivered to mothers' smartphones. The booster intervention will include activities that will enhance skills learned in the MB course. All participants will complete self-report measures of prenatal maternal stress, emotion, depression, and skills related to the intervention (e.g., mindfulness). Infant neurodevelopmental health will be measured via brain and behavioral indicators of self-regulation, including performance-based indicators of executive function and corollary prefrontal cortex maturation and dimensional phenotypes of disruptive behavior, particularly irritability.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •≥ 18 years old;
- •enrolled under 22 weeks gestation;
- •receiving prenatal care from a Northwestern University prenatal care clinic & planning to deliver at Northwestern Hospitals;
- •English-speaking
- •Participants must own a smartphone and be must be willing to receive text messages and respond to short online surveys using their smartphone.
- •Eligible participants must also agree to wear a wireless adhesive sensor, the BioStamp, daily, throughout the 12-week MB course.
- •Eligible participants will also have WiFi internet access for the duration of their participation in the study, in order to complete online questionnaires and upload sensor data.
- •Eligible participants must also agree to have their child participate in the neurodevelopmental assessments from birth-12 months.
排除标准
- •Women will be ineligible to participate in this study if they have known pregnancy or chronic medical complications that may place their infant at risk for neurological disorders (e.g., HIV; acute cytomegalovirus infection (CMV); toxoplasmosis; zika virus; Phenylketonuria (PKU); chromosomal anomalies; metabolic disorder; substance use disorders) or significant mental health disorders (e.g., schizophrenia, bipolar disorder, psychosis) which could interfere with study adherence.
- •Participants unable to wear the BioStamp Sensor due to known skin sensitivity (e.g., allergy to adhesives or silicone), current skin irritation, or broken skin at the placement site will not be eligible to participate.
- •Participants with a pacemaker or other sensitive medical device will be excluded.
- •Women will not be eligible to participate if unable to provide informed consent, complete MB sessions, or complete study assessments in English.
- •Women who are currently participating in an MB course at the time of recruitment will not be eligible to participate.
结局指标
主要结局
Disruptive Behavior Diagnostic Observation Schedule (DB DOS)
时间窗: 12 months, 24 months
The DB DOS is a standardized observation of infant arousal, soothability, reactivity, and temper loss. During early infancy, the
MAP-DB
时间窗: 1 month, 7 months, 12 months, 24 months
Parent report measure of infant irritability.
State Trait Anxiety Inventory (STAI)
时间窗: Prenatal, 1 month, 3 months, 7 months, 12 months, 24 months
The STAI is a 40 item self report questionnaire that assesses both state anxiety and trait anxiety.
Perceived Stress Scale (PSS)
时间窗: Prenatal, 1 month, 3 months, 7 months, 12 months, 24 months
The PSS is a self-report measure of the degree to which an individual perceives their life situations to be stressful. The instrument includes 10 items that assess how unpredictable, uncontrollable, and overloaded respondents find their lives, and assess current levels of experienced stress.
PROMIS Depression
时间窗: Prenatal, 1 month, 3 months, 7 months, 12 months, 24 months
Mothers complete a 28-item scale that assesses depressive symptoms experienced in the past 7 days.
次要结局
- Five Facet Mindfulness Questionnaire (FFMQ)(Prenatal, 1 month, 3 months, 7 months, 12 months, 24 months)
- Alberta Infant Motor Scale (AIMS)(1 month)
- Birthweight(Birth)
- Brief Infant Toddler Social Emotional Assessment (BITSEA)(12 months, 24 months)
- Parenting Stress Index (PSI) - Role Restriction Subscale(3 months, 7 months, 12 months, 24 months)
- Maternal Heart Rate Variability(Pregnancy (duration 14 weeks))
- Inflammatory and neuroimmune biomarkers(At birth)
- ERP mean amplitude(1 month, 12 months, 24 months)
- Bayley Scales of Infant Development(7 months, 12 months, 24 months)
- Preschool Age Psychiatric Assessment (PAPA)(24 months)
- NICU Neonatal Behavioral Scale (NNNS)(1 month)
- General Movements Assessment (GMA)(1 month)
- Infant Behavior Questionnaire-Revised (IBQ-R) short form(1 month, 7 months, 12 months)
- Behavioral Activation Depression Scale (BADS) - short form(prenatal, 3 months, 7 months, 12 months, 24 months)
- Negative Mood Regulation Scale (NMRS)(prenatal, 3 months, 7 months, 12 months, 24 months)
- Maternal Infant Responsiveness Instrument (MIRI)(1 month, 7 months, 12 months)
- Early Childhood Irritability Related Impairment Interview (E-CRI)(24 months)
- Perceived Stress Scale (PSS)(1 month, 3 months, 7 months, 12 months, 24 months)
- Parental Cognitions and Conduct Toward the Infant Scale (PACOTIS)(1 month, 3 months, 7 months, and 12 months)
- Test of Infant Motor Performance (TIMP)(1 month)
- Prefrontal cortex thickness(1 month, 12 months, 24 months)
- EEG power(1 month, 12 months, 24 months)
- Medical Outcomes Study (MOS) Social Support Survey(Prenatal, 3 months, 7 months, 12 months, 24 months)
- MacArthur-Bates Communicative Development Inventories (MCDI)(12 months, 24 months)
研究者
Lauren Wakschlag, PhD
Professor
Northwestern University