Promoting Healthy Brain Development: Wellness for 2 Study

NCT ID: NCT05052281

Last Updated: 2025-02-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-15
• Study Completion Date: 2024-07-31

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.

Conditions

Prenatal Stress

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Stress monitoring (control) group

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

Group Type: ACTIVE_COMPARATOR

Biostamp nPoint Device

Intervention Type: 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

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.

Group Type: EXPERIMENTAL

Mothers and Babies (MB) Course

Intervention Type: 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.

Just in Time Intervention (JITI) Content

Intervention Type: 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.

Biostamp nPoint Device

Intervention Type: 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).

Interventions

Mothers and Babies (MB) Course

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 Type: BEHAVIORAL

Just in Time Intervention (JITI) Content

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 Type: BEHAVIORAL

Biostamp nPoint 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 Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Ann & Robert H Lurie Children's Hospital of Chicago

OTHER

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Lauren Wakschlag, PhD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lauren Wakschlag, PhD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

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

Chicago, Illinois, United States

Northwestern University (Feinberg School of Medicine)

Chicago, Illinois, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 17355398 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19661759 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 14531585 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19162414 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22299010 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23456540 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23793487 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21806298 (View on PubMed)

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 Sep 17. doi: 10.1007/s00737-025-01619-5. Online ahead of print.

Reference Type: DERIVED

PMID: 40960524 (View on PubMed)

Other Identifiers

IRB 2019-2515

Identifier Type: -

Identifier Source: org_study_id