Clinical trial NCT05052281: Promoting Healthy Brain Development: Wellness for 2 Study
Official title: Promoting Healthy Brain Development Via Prenatal Stress Reduction: An Innovative Precision Medicine Approach
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prenatal Stress
Keywords: Pregnancy
Pre-natal
Post-Natal
Neurodevelopment
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Ann & Robert H Lurie Children's Hospital of Chicago
First posted: 2021-09-22
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Disruptive Behavior Diagnostic Observation Schedule (DB DOS)
timeFrame: 12 months, 24 months
measure: Perceived Stress Scale (PSS)
timeFrame: Prenatal, 1 month, 3 months, 7 months, 12 months, 24 months
measure: MAP-DB
timeFrame: 1 month, 7 months, 12 months, 24 months
measure: PROMIS Depression
timeFrame: Prenatal, 1 month, 3 months, 7 months, 12 months, 24 months
measure: State Trait Anxiety Inventory (STAI)
timeFrame: Prenatal, 1 month, 3 months, 7 months, 12 months, 24 months
Secondary outcomes:
measure: Five Facet Mindfulness Questionnaire (FFMQ)
timeFrame: Prenatal, 1 month, 3 months, 7 months, 12 months, 24 months
measure: NICU Neonatal Behavioral Scale (NNNS)
timeFrame: 1 month
measure: Test of Infant Motor Performance (TIMP)
timeFrame: 1 month
measure: General Movements Assessment (GMA)
timeFrame: 1 month
measure: Alberta Infant Motor Scale (AIMS)
timeFrame: 1 month
measure: Maternal Heart Rate Variability
timeFrame: Pregnancy (duration 14 weeks)
measure: Prefrontal cortex thickness
timeFrame: 1 month, 12 months, 24 months
measure: Inflammatory and neuroimmune biomarkers
timeFrame: At birth
measure: EEG power
timeFrame: 1 month, 12 months, 24 months
measure: ERP mean amplitude
timeFrame: 1 month, 12 months, 24 months
measure: Birthweight
timeFrame: Birth
measure: Maternal Infant Responsiveness Instrument (MIRI)
timeFrame: 1 month, 7 months, 12 months
measure: Infant Behavior Questionnaire-Revised (IBQ-R) short form
timeFrame: 1 month, 7 months, 12 months
measure: Bayley Scales of Infant Development
timeFrame: 7 months, 12 months, 24 months
measure: Preschool Age Psychiatric Assessment (PAPA)
timeFrame: 24 months
measure: Brief Infant Toddler Social Emotional Assessment (BITSEA)
timeFrame: 12 months, 24 months
measure: Early Childhood Irritability Related Impairment Interview (E-CRI)
timeFrame: 24 months
measure: Perceived Stress Scale (PSS)
timeFrame: 1 month, 3 months, 7 months, 12 months, 24 months
measure: Behavioral Activation Depression Scale (BADS) - short form
timeFrame: prenatal, 3 months, 7 months, 12 months, 24 months
measure: Negative Mood Regulation Scale (NMRS)
timeFrame: prenatal, 3 months, 7 months, 12 months, 24 months
measure: Parenting Stress Index (PSI) - Role Restriction Subscale
timeFrame: 3 months, 7 months, 12 months, 24 months
measure: Parental Cognitions and Conduct Toward the Infant Scale (PACOTIS)
timeFrame: 1 month, 3 months, 7 months, and 12 months
measure: MacArthur-Bates Communicative Development Inventories (MCDI)
timeFrame: 12 months, 24 months
measure: Medical Outcomes Study (MOS) Social Support Survey
timeFrame: Prenatal, 3 months, 7 months, 12 months, 24 months
Other outcomes:
measure: Family Life Impairment Scale (FLIS)
timeFrame: 12 months, 24 months
measure: PROMIS Anxiety
timeFrame: Prenatal, 1 month, 3 months, 7 months, 12 months, 24 months
measure: Family Relationship Index (FRI)
timeFrame: prenatal, 3 months, 7 months, 12 months, 24 months
Locations:
city: Chicago
country: United States
facility: Ann & Robert H. Lurie Children's Hospital of Chicago
state: Illinois
city: Chicago
country: United States
facility: Northwestern University (Feinberg School of Medicine)
state: Illinois
Study officials:
affiliation: Northwestern University
name: Lauren Wakschlag, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Talge NM, Neal C, Glover V; Early Stress, Translational Research and Prevention Science Network: Fetal and Neonatal Experience on Child and Adolescent Mental Health. Antenatal maternal stress and long-term effects on child neurodevelopment: how and why? J Child Psychol Psychiatry. 2007 Mar-Apr;48(3-4):245-61. doi: 10.1111/j.1469-7610.2006.01714.x.
citation: Kinsella MT, Monk C. Impact of maternal stress, depression and anxiety on fetal neurobehavioral development. Clin Obstet Gynecol. 2009 Sep;52(3):425-40. doi: 10.1097/GRF.0b013e3181b52df1.
citation: O'Connor TG, Heron J, Golding J, Glover V; ALSPAC Study Team. Maternal antenatal anxiety and behavioural/emotional problems in children: a test of a programming hypothesis. J Child Psychol Psychiatry. 2003 Oct;44(7):1025-36. doi: 10.1111/1469-7610.00187.
citation: de Bruijn AT, van Bakel HJ, van Baar AL. Sex differences in the relation between prenatal maternal emotional complaints and child outcome. Early Hum Dev. 2009 May;85(5):319-24. doi: 10.1016/j.earlhumdev.2008.12.009. Epub 2009 Jan 21.
citation: Grizenko N, Fortier ME, Zadorozny C, Thakur G, Schmitz N, Duval R, Joober R. Maternal Stress during Pregnancy, ADHD Symptomatology in Children and Genotype: Gene-Environment Interaction. J Can Acad Child Adolesc Psychiatry. 2012 Feb;21(1):9-15.
citation: Mendelson T, Leis JA, Perry DF, Stuart EA, Tandon SD. Impact of a preventive intervention for perinatal depression on mood regulation, social support, and coping. Arch Womens Ment Health. 2013 Jun;16(3):211-8. doi: 10.1007/s00737-013-0332-4. Epub 2013 Mar 2.
citation: Tandon SD, Leis JA, Mendelson T, Perry DF, Kemp K. Six-month outcomes from a randomized controlled trial to prevent perinatal depression in low-income home visiting clients. Matern Child Health J. 2014 May;18(4):873-81. doi: 10.1007/s10995-013-1313-y.
citation: Tandon SD, Perry DF, Mendelson T, Kemp K, Leis JA. Preventing perinatal depression in low-income home visiting clients: a randomized controlled trial. J Consult Clin Psychol. 2011 Oct;79(5):707-12. doi: 10.1037/a0024895.