Promoting Healthy Brain Development: Wellness for 2 Study

Northwestern University100 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

100

Conditions

Prenatal Stress

Interventions

Mothers and Babies (MB) CourseBEHAVIORAL

The Mothers and Babies course (MB) is a 12-session manualized stress-reduction intervention that will be delivered to participants, prenatally, with an integrated technology suite designed for timely detection and response to maternal stress.

Just in Time Intervention (JITI) ContentBEHAVIORAL

Participants will also receive additional MB intervention content in the form of "just-in-time" text messages, which will be sent to participants' smartphones every other day for up to 12 weeks. During the current trial, participants will receive text message prompts with links to additional stress reduction content based on a combination of their objective (sensor) and subjective (EMA) stress responses from the previous day.

Biostamp nPoint Device

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * ≥ 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. Exclusion Criteria: * 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.

Locations (2)

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, United States

Northwestern University (Feinberg School of Medicine)

Chicago, Illinois, United States

Outcomes

Primary Outcomes

Disruptive Behavior Diagnostic Observation Schedule (DB DOS)

The DB DOS is a standardized observation of infant arousal, soothability, reactivity, and temper loss. During early infancy, the

Time frame: 12 months, 24 months

Perceived Stress Scale (PSS)

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.

Time frame: Prenatal, 1 month, 3 months, 7 months, 12 months, 24 months

MAP-DB

Parent report measure of infant irritability.

Time frame: 1 month, 7 months, 12 months, 24 months

PROMIS Depression

Mothers complete a 28-item scale that assesses depressive symptoms experienced in the past 7 days.

Time frame: Prenatal, 1 month, 3 months, 7 months, 12 months, 24 months

State Trait Anxiety Inventory (STAI)

The STAI is a 40 item self report questionnaire that assesses both state anxiety and trait anxiety.

Time frame: Prenatal, 1 month, 3 months, 7 months, 12 months, 24 months

Secondary Outcomes

Five Facet Mindfulness Questionnaire (FFMQ)

The FFMQ is a 39-item self report survey that taps into five areas of mindfulness, including observation, description, aware actions, non-judgmental inner experience, and non-reactivity.

Time frame: Prenatal, 1 month, 3 months, 7 months, 12 months, 24 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

During the intervention period, participants will be asked to wear the BioStamp nPoint sensor, daily, while engaging in their usual activities (e.g., sleep, showering, exercise). The BioStamp Sensor is a thin, wearable patch, equipped with wireless high-range 6-axis gyroscope + accelerometer, and sEMG and ECG sensors, that adheres to the skin using a disposable medical-grade adhesive sticker (with adhesive similar to Band-Aid).

NICU Neonatal Behavioral Scale (NNNS)

The NNNS is an assessment of neurobehavioral organization, neurological reflexes, motor development - active and passive tone, and signs of stress and withdrawal in neonates, developed for use with at-risk or drug-exposed infants but has been normed with typically developing infants.

Test of Infant Motor Performance (TIMP)

The TIMP is a norm-referenced measure designed to evaluate motor control and organization of posture and movement for functional activities in infants 32 weeks gestational age to four months post-term age and measures both spontaneous behaviors and elicited items.

Time frame: 1 month

General Movements Assessment (GMA)

General movements are a developmentally regulated pattern of spontaneous motor activity. By 10-15 weeks of age, the predominant general movements seen are called Fidgety Movements - a pattern of continuous, small amplitude movements of the neck, trunk and limbs during wakefulness that disappear with agitation. These patterns are identifiable and are classified as normal if present (intermittent or continual), and abnormal if exaggerated (with respect to speed and amplitude), sporadic (interspersed with long pauses) or absent. Babies are observed for up to 30 minutes in a supine position to assess for spontaneous movements.

Time frame: 1 month

Alberta Infant Motor Scale (AIMS)

The Alberta Infant Motor Scale (AIMS) is a 10-20 minute norm referenced, standardized, gross motor assessment. Infants are observed in four positions: prone, sitting, supine, and standing. For each subscale, items are scored as "observed" or "not observed". A total raw score and percentile are calculated.

Time frame: 1 month

Maternal Heart Rate Variability

variability/physiological stress as indicated by a machine learned model applied to electrocardiogram (ECG) signals.

Time frame: Pregnancy (duration 14 weeks)

Prefrontal cortex thickness

Cortical thickness and surface area of pre-frontal cortex regions, which have been linked to child irritability and Infant dysregulation, is measured through natural sleep MRI.

Time frame: 1 month, 12 months, 24 months

Inflammatory and neuroimmune biomarkers

Placenta and cord blood will be collected at birth. Tests to be performed on these samples include measurement of inflammatory markers related to stress, such as a multiplex immunoassay panel of the following cytokines and chemokines: (IL-6, IL-8, IL-10, C-reactive protein, TNF-alpha, TGF-beta, IL-1beta, procalcitonin, cortisol).

Time frame: At birth

EEG power

The baby will complete a baseline or resting EEG for 2-5 minutes and then hear an auditory oddball paradigm with speech syllables while resting for \~10 min. EEG (electroencephalogram) power will be measured as a marker infant neurodevelopment.

Time frame: 1 month, 12 months, 24 months

ERP mean amplitude

The baby will complete a baseline or resting EEG for 2-5 minutes and then hear an auditory oddball paradigm with speech syllables while resting for \~10 min. ERP (event related potential) mean amplitude will be measured as a marker of infant neurodevelopment.

Time frame: 1 month, 12 months, 24 months

Birthweight

Infant birthweight will be obtained from EHR data collected at the hospital at birth

Time frame: Birth

Maternal Infant Responsiveness Instrument (MIRI)

The MIRI is a 22 item questionnaire designed to assess a mother's feelings about her infant, her recognition of her responsiveness to the infant, and her infants responses.

Time frame: 1 month, 7 months, 12 months

Infant Behavior Questionnaire-Revised (IBQ-R) short form

The IBQ-R is a parent-report survey designed to measure multiple dimensions of temperament in infants up to age 12 months.

Time frame: 1 month, 7 months, 12 months

Bayley Scales of Infant Development

The Bayley Scales of Infant and Toddler Development Fourth Edition (Bayley-4) is a five-domain assessment tool used to determine developmental delays in children. The developmental domains are cognitive, language, motor, social-emotional, and adaptive behavior, and include direct assessment of the child and parent report.

Time frame: 7 months, 12 months, 24 months

Preschool Age Psychiatric Assessment (PAPA)

Parent structured interview for diagnosing psychiatric disorders in children ages 2-5.

Time frame: 24 months

Brief Infant Toddler Social Emotional Assessment (BITSEA)

Parent report measure of behavior problems and social competencies in children ages 1-3 that identifies delays or deficits in areas of social-emotional development.

Time frame: 12 months, 24 months

Early Childhood Irritability Related Impairment Interview (E-CRI)

The E-CRI is a semi-structured interview designed to measure early childhood impairment resulting from young children's tantrums and irritability across various contexts.

Time frame: 24 months

Perceived Stress Scale (PSS)

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.

Time frame: 1 month, 3 months, 7 months, 12 months, 24 months

Behavioral Activation Depression Scale (BADS) - short form

Self-report 9-item measure of behaviors that indicate depression and can be targeted for change by cognitive behavioral therapy and behavior activation. Mothers complete this measure regarding behaviors experienced over the past week.

Time frame: prenatal, 3 months, 7 months, 12 months, 24 months

Negative Mood Regulation Scale (NMRS)

This self-report, 30-item scale measures expectancies and beliefs that the mothers have regarding their abilities to alleviate their negative mood, anger, anxiety and depression.

Time frame: prenatal, 3 months, 7 months, 12 months, 24 months

Parenting Stress Index (PSI) - Role Restriction Subscale

The PSI Role Restriction subscale includes 7 mother-report items regarding her feelings of limited freedom and restriction of her identity to the parenting role.

Time frame: 3 months, 7 months, 12 months, 24 months

Parental Cognitions and Conduct Toward the Infant Scale (PACOTIS)

The PACOTIS is a mother report measure of their actions, thoughts, and feelings during interactions with their baby.

Time frame: 1 month, 3 months, 7 months, and 12 months

MacArthur-Bates Communicative Development Inventories (MCDI)

The MCDI is a parent-report questionnaire about their child's communication and language development. The Words \& Gestures form is used at 12 months and the Words \& Sentences form is used at 24 months.

Time frame: 12 months, 24 months

Medical Outcomes Study (MOS) Social Support Survey

The MOS Social Support Survey is a 19-item self-report measure of the mother's availability of social support in a variety of domains including emotional support, tangible support, affectionate support, and positive social interaction.

Time frame: Prenatal, 3 months, 7 months, 12 months, 24 months