Promoting Healthy Brain Development: Wellness for 2 Study

NCT05052281 | Completed DMC FDA Device

• 1 other identifier: IRB 2019-2515
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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).

Conditions

Prenatal Stress

Keywords

Pregnancy; Pre-natal; Post-Natal; Neurodevelopment

Outcome Measures

Primary Outcomes (5)

• 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

  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.

  Prenatal, 1 month, 3 months, 7 months, 12 months, 24 months

• MAP-DB

  Parent report measure of infant irritability.

  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.

  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.

  Prenatal, 1 month, 3 months, 7 months, 12 months, 24 months

Secondary Outcomes (24)

• Five Facet Mindfulness Questionnaire (FFMQ)

  Prenatal, 1 month, 3 months, 7 months, 12 months, 24 months

• NICU Neonatal Behavioral Scale (NNNS)

  1 month

• Test of Infant Motor Performance (TIMP)

  1 month

• General Movements Assessment (GMA)

  1 month

• Alberta Infant Motor Scale (AIMS)

  1 month

Other Outcomes (3)

• Family Life Impairment Scale (FLIS)

  12 months, 24 months

• PROMIS Anxiety

  Prenatal, 1 month, 3 months, 7 months, 12 months, 24 months

• Family Relationship Index (FRI)

  prenatal, 3 months, 7 months, 12 months, 24 months

Study Arms (2)

Intervention group

EXPERIMENTAL

The first MB course session and technology training will take place in-person, prior to 23 weeks gestation. 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. Sessions are delivered 1-on-1 with a trained facilitator and are based on principles of cognitive-behavioral therapy (CBT) and attachment theory. The MB course is divided into 3 sections: 1) Pleasant Activities; 2) Thoughts; 3) Contact with Others. Throughout each module, mindfulness skills training will be integrated as a strategy to help "center" participants. All participants will receive a Participant Manual for Families, containing worksheets that correspond to the 12 sessions.

Behavioral: Mothers and Babies (MB) Course; Behavioral: Just in Time Intervention (JITI) Content; Device: Biostamp nPoint Device

Stress monitoring (control) group

ACTIVE COMPARATOR

This group will not receive any additional intervention but will engage in stress monitoring via biosensors and EMA text messages through the 14 week period

Device: Biostamp nPoint Device

Interventions

Mothers and Babies (MB) Course BEHAVIORAL

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.

Intervention group

Just in Time Intervention (JITI) Content BEHAVIORAL

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.

Intervention group

Biostamp nPoint Device DEVICE

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).

Intervention group; Stress monitoring (control) group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northwestern University: lead
• Ann & Robert H Lurie Children's Hospital of Chicago: collaborator

Study Sites (2)

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

Chicago, Illinois, 60611, United States

Location

Northwestern University (Feinberg School of Medicine)

Chicago, Illinois, 60611, United States

Location

Related Publications (9)

• 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.

  PMID: 17355398 BACKGROUND

• 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.

  PMID: 19661759 BACKGROUND

• 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.

  PMID: 14531585 BACKGROUND

• 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.

  PMID: 19162414 BACKGROUND

• 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.

  PMID: 22299010 BACKGROUND

• 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.

  PMID: 23456540 BACKGROUND

• 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.

  PMID: 23793487 BACKGROUND

• 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.

  PMID: 21806298 BACKGROUND

• Tandon SD, Moskowitz JT, Edwards RC, Zhang Y, Giase G, Sinche B, Blum AL, Krislov S, Reynolds HM, Rangarajan A, Cummings P, Petitclerc A, Alshurafa N, Grobman WA, Ward EA, Wakschlag LS. Effects of a Personalized Stress Management Intervention on Maternal Mental Health: A Randomized Clinical Trial. Arch Womens Ment Health. 2025 Dec;28(6):1585-1595. doi: 10.1007/s00737-025-01619-5. Epub 2025 Sep 17.

  PMID: 40960524 DERIVED

Study Officials

• Lauren Wakschlag, PhD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 30, 2019
• First Posted: September 22, 2021
• Study Start: July 15, 2019
• Primary Completion: July 28, 2024
• Study Completion: July 31, 2024
• Last Updated: February 19, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be stored for at least 7 years.

Locations

US (2)