Prenatal StressNCT05052281

Promoting Healthy Brain Development: Wellness for 2 Study

A study testing Mothers and Babies (MB) Course, Just in Time Intervention (JITI) Content and Biostamp nPoint Device in people with Prenatal Stress, run by Northwestern University at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 years, women onlyHealthy volunteers can take part
Conditions the study is for: Prenatal Stress
What is being tested?: Mothers and Babies (MB) Course, Just in Time Intervention (JITI) Content and Biostamp nPoint Device
Type of treatment: Medical device, Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 2 sitesUnited States
Study dates: 15 Jul 2019to 31 Jul 2024
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

≥ 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.

Who cannot join

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.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
Northwestern University (Feinberg School of Medicine)
Chicago, Illinois, 60611

Other trials in United States

About this study

Official title: Promoting Healthy Brain Development Via Prenatal Stress Reduction: An Innovative Precision Medicine Approach

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).

Read the 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
Being tested: Mothers and Babies (MB) Course, Just in Time Intervention (JITI) Content, Biostamp nPoint Device
Keywords: Pregnancy, Pre-natal, Post-Natal, Neurodevelopment

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Mothers and Babies (MB) CourseBehavioural
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) ContentBehavioural
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 DeviceDevice
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).

Study groups in NCT05052281
Study group	Role	What they receive
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. Receives: 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 Receives: Device: Biostamp nPoint Device

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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.
Measured: Prenatal, 1 month, 3 months, 7 months, 12 months, 24 months
MAP-DB
Parent report measure of infant irritability.
Measured: 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.
Measured: 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.
Measured: Prenatal, 1 month, 3 months, 7 months, 12 months, 24 months

Secondary outcomes (24)

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.
Measured: Prenatal, 1 month, 3 months, 7 months, 12 months, 24 months
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.
Measured: 1 month
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.
Measured: 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.
Measured: 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.
Measured: 1 month
Maternal Heart Rate Variability
variability/physiological stress as indicated by a machine learned model applied to electrocardiogram (ECG) signals.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 1 month, 12 months, 24 months
Birthweight
Infant birthweight will be obtained from EHR data collected at the hospital at birth
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 7 months, 12 months, 24 months
Preschool Age Psychiatric Assessment (PAPA)
Parent structured interview for diagnosing psychiatric disorders in children ages 2-5.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Prenatal, 3 months, 7 months, 12 months, 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Jul 201931 Jul 2024

First posted22 Sep 2021
Study start15 Jul 2019
Primary completion28 Jul 2024
Study completion31 Jul 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (9)Papers the sponsor has linked to this study.
Other trials for Prenatal StressStudies of the same condition, open and under way.
More trials run by Northwestern UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05052281
Sponsor's protocol ID: IRB 2019-2515
Status last verified: Feb 2025
First submitted: 30 Aug 2019
Last updated: 19 Feb 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Yes: De-identified data will be shared with other investigators. Investigators from outside the study will be asked to sign an agreement of confidentiality in order to receive the data requested. Data will be stored for at least 7 years. We plan to archive the de-identified data in a data repository for future use by other researchers, after the study is completed. Additionally, data from this study will be used in the Mental Health Earlier Synthetic Cohort (MHESC) Study in order to generate a pragmatic clinical risk calculator to predict preschool psychopathology. MHESC pools three extramural cohorts at Northwestern University and Washington University in St. Louis, one of which is the Wellness for 2 Study to form a clinically enriched "synthetic" cohort. Therefore, data will be shared with authorized individuals at Washington University.

Publications

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.
PubMed 17355398
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.
PubMed 19661759
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.
PubMed 14531585
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.
PubMed 19162414
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.
PubMed 22299010
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.
PubMed 23456540
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.
PubMed 23793487
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.
PubMed 21806298
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.
PubMed 40960524

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Mobile Prenatal Education for Expectant Fathers and Its Effects on Bonding, Stress, Breastfeeding and Marital Satisfaction
Breastfeeding Attitudes, Breast Feeding
Not yet recruiting
Personalized Care for Prenatal Stress Reduction & Prevention of Preterm Birth (PTB) Disparities
Preterm Birth Complication, Preterm Birth

All Prenatal Stress trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Promoting Healthy Brain Development Via Prenatal Stress Reduction: An Innovative Precision Medicine Approach
ClinicalTrials.gov ID: NCT05052281
Acronym / sponsor ID: IRB 2019-2515
Conditions: Prenatal Stress
Keywords: Pregnancy, Pre-natal, Post-Natal, Neurodevelopment
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: Northwestern UniversityUniversity, hospital or other
Collaborators: Ann & Robert H Lurie Children's Hospital of Chicago
Study start: 15 Jul 2019 (actual)
Primary completion: 28 Jul 2024 (actual)
Study completion: 31 Jul 2024 (actual)
First posted: 22 Sep 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Intervention group	Experimental	Behavioral: Mothers and Babies (MB) Course, Behavioral: Just in Time Intervention (JITI) Content, Device: Biostamp nPoint DeviceThe 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.
Stress monitoring (control) group	Active comparator	Device: Biostamp nPoint DeviceThis group will not receive any additional intervention but will engage in stress monitoring via biosensors and EMA text messages through the 14 week period

Who may qualify

Ages: 18 to 65 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

≥ 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.

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Mothers and Babies (MB) CourseThe 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.	Behavioural	Intervention group
Just in Time Intervention (JITI) ContentParticipants 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.	Behavioural	Intervention group
Biostamp nPoint DeviceDuring 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).	Device	Intervention group, Stress monitoring (control) group

Primary outcome

Disruptive Behavior Diagnostic Observation Schedule (DB DOS)
Time frame: 12 months, 24 months
The DB DOS is a standardized observation of infant arousal, soothability, reactivity, and temper loss. During early infancy, the
Perceived Stress Scale (PSS)
Time frame: 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.
MAP-DB
Time frame: 1 month, 7 months, 12 months, 24 months
Parent report measure of infant irritability.
PROMIS Depression
Time frame: 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.
State Trait Anxiety Inventory (STAI)
Time frame: 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.

24 secondary outcomes

Five Facet Mindfulness Questionnaire (FFMQ)
Time frame: Prenatal, 1 month, 3 months, 7 months, 12 months, 24 months
NICU Neonatal Behavioral Scale (NNNS)
Time frame: 1 month
Test of Infant Motor Performance (TIMP)
Time frame: 1 month
General Movements Assessment (GMA)
Time frame: 1 month
Alberta Infant Motor Scale (AIMS)
Time frame: 1 month
Maternal Heart Rate Variability
Time frame: Pregnancy (duration 14 weeks)
Prefrontal cortex thickness
Time frame: 1 month, 12 months, 24 months
Inflammatory and neuroimmune biomarkers
Time frame: At birth
EEG power
Time frame: 1 month, 12 months, 24 months
ERP mean amplitude
Time frame: 1 month, 12 months, 24 months
Birthweight
Time frame: Birth
Maternal Infant Responsiveness Instrument (MIRI)
Time frame: 1 month, 7 months, 12 months
Infant Behavior Questionnaire-Revised (IBQ-R) short form
Time frame: 1 month, 7 months, 12 months
Bayley Scales of Infant Development
Time frame: 7 months, 12 months, 24 months
Preschool Age Psychiatric Assessment (PAPA)
Time frame: 24 months
Brief Infant Toddler Social Emotional Assessment (BITSEA)
Time frame: 12 months, 24 months
Early Childhood Irritability Related Impairment Interview (E-CRI)
Time frame: 24 months
Perceived Stress Scale (PSS)
Time frame: 1 month, 3 months, 7 months, 12 months, 24 months
Behavioral Activation Depression Scale (BADS) - short form
Time frame: prenatal, 3 months, 7 months, 12 months, 24 months
Negative Mood Regulation Scale (NMRS)
Time frame: prenatal, 3 months, 7 months, 12 months, 24 months
Parenting Stress Index (PSI) - Role Restriction Subscale
Time frame: 3 months, 7 months, 12 months, 24 months
Parental Cognitions and Conduct Toward the Infant Scale (PACOTIS)
Time frame: 1 month, 3 months, 7 months, and 12 months
MacArthur-Bates Communicative Development Inventories (MCDI)
Time frame: 12 months, 24 months
Medical Outcomes Study (MOS) Social Support Survey
Time frame: Prenatal, 3 months, 7 months, 12 months, 24 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2025.
Background: PubMed 17355398Talge 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.
Background: PubMed 19661759Kinsella 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.
Background: PubMed 14531585O'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.
Background: PubMed 19162414de 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.
Background: PubMed 22299010Grizenko 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.
Background: PubMed 23456540Mendelson 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.
Background: PubMed 23793487Tandon 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.
Background: PubMed 21806298Tandon 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.
Derived from this study: PubMed 40960524Tandon 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.
Individual participant dataSharing planned: Yes. De-identified data will be shared with other investigators. Investigators from outside the study will be asked to sign an agreement of confidentiality in order to receive the data requested. Data will be stored for at least 7 years. We plan to archive the de-identified data in a data repository for future use by other researchers, after the study is completed. Additionally, data from this study will be used in the Mental Health Earlier Synthetic Cohort (MHESC) Study in order to generate a pragmatic clinical risk calculator to predict preschool psychopathology. MHESC pools three extramural cohorts at Northwestern University and Washington University in St. Louis, one of which is the Wellness for 2 Study to form a clinically enriched "synthetic" cohort. Therefore, data will be shared with authorized individuals at Washington University.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Lauren Wakschlag, PhD principal investigator

Northwestern University

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disruptive Behavior Diagnostic Observation Schedule (DB DOS) (time frame: 12 months, 24 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05052281, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2025.