PregnancyWe2-PNCT03615261
Wellness For 2: A Feasibility and Acceptability Pilot
A study testing Mothers and Babies (Enhanced) in people with Pregnancy and Prenatal Stress, run by Northwestern University at 1 site in United States.
Trial summary
The investigators are studying strategies and tools that women can use to manage stress and wellness during pregnancy. The purpose of this project is to test a technology-enhanced version of a wellness intervention for women during their pregnancy (the Mothers and Babies course; MB). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy, Prenatal Stress
- What is being tested?
- Mothers and Babies (Enhanced)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jul 2018to 31 Jan 2021
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 10-18 weeks gestation
- singleton pregnancy
- receiving prenatal care from a Northwestern University prenatal care clinic \& planning to deliver at Northwestern Hospitals
- English-speaking
- must own a smartphone
- must be willing to receive text messages and respond to short online surveys using their smartphone
- must also agree to wear a wireless adhesive sensor daily
- must have WiFi internet access for the duration of their participation in the study
Who cannot join
- have known chronic medical or pregnancy 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)
- have significant mental health disorders (e.g., schizophrenia, bipolar disorder, psychosis) which could interfere with study adherence
- 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
- pacemaker or other sensitive medical device
- unable to provide informed consent, complete MB sessions, or complete study assessments in English
- currently participating in another MB course at the time of recruitment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Promoting Healthy Brain Development Via Prenatal Stress Reduction: An Innovative Precision Medicine Approach: An Intervention Feasibility and Acceptability Pilot
The investigators are studying strategies and tools that women can use to manage stress and wellness during pregnancy. The purpose of this project is to test a technology-enhanced version of a wellness intervention for women during their pregnancy (the Mothers and Babies course; MB). The technology that the investigators will test includes wearable heart rate sensors, smartphone text message surveys, and intervention materials delivered through text message.
Read the detailed description
Perinatal "early life" stress (ELS) has significant consequences for mothers and their infants.(1-3) Prolonged prenatal stress places pregnant women at increased risk for depression, health risk behaviors, and poor overall health and quality of life. Likewise, fetal exposure to stress places infants at greater risk of neurodevelopmental disruptions.(4,5)
Prior clinical trials led by co-PI Darius Tandon have demonstrated that pregnant women, particularly those in low income environments, demonstrate positive health and parenting benefits as a result of receiving prenatal stress reduction interventions.(6-8) The stress-reduction intervention proposed in the overarching Promoting Healthy Brains Project (PHBP), the Mothers and Babies course (MB), is a scalable, manualized evidence-based cognitive-behavioral intervention that can be adapted to meet client needs (e.g., setting, dose, timing, modality) without compromising fidelity. However, as there is substantial heterogeneity in maternal responsiveness to prenatal stress-reduction interventions, MB in its current form may be too low-intensity to improve fetal outcomes. Although a few studies have examined impact of interventions like MB on developmental outcomes, the extant evidence base does not provide strong support for intervention effects. Further, state-of-the-art neurodevelopmental methods have not been employed to detect how manipulation of early exposure to stress may effect brain:behavior patterns in early life. Advancing this is the overarching goal of the PHBP.
A crucial component of the proposed work involves an enhanced version of the 12-session, one-on-one version of MB with 1) mindfulness training content; 2) inter-session text messages prompting skills reinforcement, self-monitoring, and homework reminders; 3) adaptive, real-time stress monitoring that will optimize the intervention by identifying the key point at which to deliver just-in-time stress intervention content to individual participants.
The investigators will ask pregnant women to wear a long-wearing, unobtrusive wireless ECG sensor (BioStamp Research Connect; BioStamp). BioStamp sensor data will be used to detect physiological responses to stress (i.e., heart rate variability; HRV) to build a system that can be used to trigger real-time stress reduction intervention. BioStamp, a lightweight, rechargeable, and easy to use wearable device is equipped to passively and continuously measure HRV and motion. Unlike traditional "wired" ECG monitors, BioStamp can be worn under typical daily-living conditions (e.g., sleeping, showering, physical activity), with only minimal obtrusion in daily life (e.g., re-charging, re-applying adhesive).
Led by PI Laurie Wakschlag, the overarching PBHP will harness multidisciplinary expertise from Northwestern's Institute for Innovations in Developmental Sciences (DevSci), Lurie Children's Hospital, Center for Community Health, McCormick School of Engineering, and Feinberg School of Medicine \& Northwestern Medicine (Ob/Gyn, Preventive Medicine, Medical Social Sciences, and Pediatrics) to 1) adapt and pilot MB enhanced with mindfulness training content, and just-in-time feedback to participants regarding their in-the-moment stress responses, and 2) experimentally test the effects of the optimized intervention on maternal wellbeing pre- and postnatally, and postnatal neurodevelopmental health trajectories.
- Conditions
- Pregnancy, Prenatal Stress
- Being tested
- Mothers and Babies (Enhanced)
- Keywords
- prenatal maternal stress, mindfulness, stress reduction, health sensing, mhealth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mothers and Babies (Enhanced)Behavioural
The course is a manualized stress-reduction intervention with an integrated tech suite designed for timely detection and response to stress. Based on Cognitive-Behavioral Therapy \& attachment theory, MB is divided into 3 sections: Pleasant Activities; Thoughts; Contact with Others. Each module has been enhanced with mindfulness as a strategy to help "center" participants and facilitate practice of skills. Participants receive skills training in each of the three sections as tools to improve and manage their mood. The MB course emphasizes developing \& strengthening the bond with the baby. The technology enhancement includes wearing a BioStamp sensor, and text message-based extra intervention content. Participants get worksheets linked to the 12 sessions.
| Study group | Role | What they receive |
|---|---|---|
| Mothers and Babies (Enhanced) | Experimental | The course is a manualized stress-reduction intervention with an integrated tech suite designed for timely detection and response to stress. Based on Cognitive-Behavioral Therapy \& attachment theory, MB is divided into 3 sections: Pleasant Activities; Thoughts; Contact with Others. Each module has been enhanced with mindfulness as a strategy to help "center" participants and facilitate practice of skills. Participants receive skills training in each of the three sections as tools to improve and manage their mood. The MB course emphasizes developing \& strengthening the bond with the baby. The technology enhancement includes wearing a BioStamp sensor, and text message-based extra intervention content. Participants get worksheets linked to the 12 sessions. Receives: Behavioral: Mothers and Babies (Enhanced) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Usability/Wearability Feedback
Participants will also be asked to provide survey feedback regarding the sensor's usability and wearability, and responding to the Environmental Momentary Assessments (EMAs).
Measured: At post-intervention (approx. week 13)
Intervention Acceptability
All participants will complete a brief intervention rating checklist after completing each MB module (3 total). Additional acceptability information will be ascertained during the exit interview and survey at the end of the intervention to assess participants' overall ratings of the MB course, whether they would recommend the intervention to similar women, and suggestions for intervention modifications.
Measured: After each of the 12 MB sessions (approx. weekly during weeks 2-13)
Secondary outcomes (16)
Intervention fidelity
MB intervention fidelity delivered by facilitators will be measured by collecting data on a) intervention session completion and b) fidelity of intervention implementation. Facilitators will completed an intervention Facilitator Fidelity Rating Form immediately at the end of each visit. The fidelity rating form will measure 1) How much of each topic was covered; 2) How well the participant understood each topic; 3) participant engagement in each topic; 4) Any challenges when discussing the topic.
Measured: After each of the 12 MB sessions (approx. weekly during weeks 2-13)
Ecological Momentary Assessment Subjective Stress Ratings
In-field, self-report EMAs will measure participants' negative and positive emotion, stress, and other factors (e.g., health behaviors) that may influence sensor readings. These surveys, delivered via text message, contain 4 questions on a 5-pt Likertscale from 'not at all' to 'very much', one on a 7-pt Likert scale from 'not at all' to 'very much', six on a binary yes/no scale, six on a visual analog scale from 'not at all' to 'extremely', and four for elaboration.
Measured: Five times daily for approx. weeks 1-13, and one week per month afterward until birth
Objective stress response
Investigators will continuously collect raw ECG and accelerometer data from the BioStamp Sensor.
Measured: Continuously during the intervention (approx. weeks 2-13)
Perceived Stress (State Trait Anxiety Inventory)
40 questions about stress and anxiety-related feelings on a 4-pt Likert scale from 'Almost Never' to 'Almost Always'.
Measured: Day 1, post-intervention (approx. week 13), 1 month prior to, and 1 month after delivery
Perceived Stress (Life events scale distress rating)
28 questions about the undesirability/negativity of a variety of life events that could happen to the participant or someone close to them on a 4-pt Likert scale from 'Not at all' to 'Very much'.
Measured: Day 1, post-intervention (approx. week 13), 1 month prior to, and 1 month after delivery
Perceived Stress (Perceived stress scale)
10 questions about emotions on a 5-pt Likert scale of 'Never' to 'Very Often'
Measured: Day 1, post-intervention (approx. week 13), 1 month prior to, and 1 month after delivery
Depression symptoms (behavioral activation depression scale)
25 questions about depressive feelings and behaviors on a 7-pt Likert scale from 'Not at All' to 'Completely'
Measured: Day 1, post-intervention (approx. week 13), 1 month prior to, and 1 month after delivery
Perceived stress (Prenatal Distress Questionnaire)
17 questions about feeling bothered, worried, or upset on a 3-pt Likert scale from 'Not at all' to 'Very much'; Three open-ended questions to elaborate.
Measured: Day 1, post-intervention (approx. week 13), 1 month prior to, and 1 month after delivery
Depression symptoms (PROMIS depression)
28 questions about depression-related thoughts and feelings on a 5-pt Likert scale from 'Never' to Always'
Measured: Day 1, post-intervention (approx. week 13), 1 month prior to, and 1 month after delivery
Depression symptoms (negative mood regulation scale)
30 questions about depression-related thoughts and feelings on a 5-pt Likert scale from 'Strong disagreement' to 'Strong agreement'.
Measured: Day 1, post-intervention (approx. week 13), 1 month prior to, and 1 month after delivery
Depression symptoms (MOS social support survey)
19 questions on feelings of support from others on a 5-pt Likert scale from 'None of the time' to 'All of the time'.
Measured: Day 1, post-intervention (approx. week 13), 1 month prior to, and 1 month after delivery
Depression symptoms (Experiences Questionnaire)
20 questions about thoughts and feelings on a 5-pt Likert scale from 'Never' to 'All the time'.
Measured: Day 1, post-intervention (approx. week 13), 1 month prior to, and 1 month after delivery
Depression symptoms (Edinburgh depression scale)
10 questions about negative emotions on a 4-pt Likert scale from 'No/Never' to 'Yes/A lot'.
Measured: Day 1, post-intervention (approx. week 13), 1 month prior to, and 1 month after delivery
Depression symptoms (Prenatal Health Behavior Scale)
24 questions about diet, exercise, and drug use on a 5-pt Likert scale from 'Never' to 'Very Often'
Measured: Day 1, post-intervention (approx. week 13), 1 month prior to, and 1 month after delivery
Intervention skills (five facet mindfulness questionnaire)
39 questions about mindfulness behaviors on a 5-pt Likert scale from 'Never or very rarely true' to 'Very often or always true'
Measured: Day 1, post-intervention (approx. week 13), 1 month prior to, and 1 month after delivery
Intervention skills (MB skills use survey)
35 questions about intervention skill use frequency (5-pt Likert scale from 'Every Day' to 'Not at all'), helpfulness and enjoyability (3-pt Likert scales from 'Not at all' to 'Very')
Measured: Day 1, post-intervention (approx. week 13), 1 month prior to, and 1 month after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2018
- Study start30 Jul 2018
- Primary completion31 Jan 2019
- Study completion31 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants engaged in the Mothers \& Babies Intervention while wearing a biosensor.
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Ann & Robert H Lurie Children's Hospital of Chicago
- Responsible party
- Principal investigator, Sheila Krogh-Jespersen, Northwestern University
- Investigators
- Lauren S Wakschlag, PhD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03615261
- Sponsor's protocol ID
- STU00205776B
- Acronym
- We2-P
- Status last verified
- Oct 2021
- First submitted
- 23 Jul 2018
- Last updated
- 4 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 17355398Kinsella 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 19661759O'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 14531585de 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 19162414Grizenko 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 22299010Mendelson 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 23456540Tandon 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 23793487Tandon 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
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2021. 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: An Intervention Feasibility and Acceptability Pilot
- ClinicalTrials.gov ID
- NCT03615261
- Acronym / sponsor ID
- We2-P / STU00205776B
- Conditions
- Pregnancy, Prenatal Stress
- Keywords
- prenatal maternal stress, mindfulness, stress reduction, health sensing, mhealth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Ann & Robert H Lurie Children's Hospital of Chicago
- Study start
- 30 Jul 2018 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 31 Jan 2021 (actual)
- First posted
- 3 Aug 2018 (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.
The investigators are studying strategies and tools that women can use to manage stress and wellness during pregnancy. The purpose of this project is to test a technology-enhanced version of a wellness intervention for women during their pregnancy (the Mothers and Babies course; MB). The technology that the investigators will test includes wearable heart rate sensors, smartphone text message surveys, and intervention materials delivered through text message.
Detailed description
Perinatal "early life" stress (ELS) has significant consequences for mothers and their infants.(1-3) Prolonged prenatal stress places pregnant women at increased risk for depression, health risk behaviors, and poor overall health and quality of life. Likewise, fetal exposure to stress places infants at greater risk of neurodevelopmental disruptions.(4,5)
Prior clinical trials led by co-PI Darius Tandon have demonstrated that pregnant women, particularly those in low income environments, demonstrate positive health and parenting benefits as a result of receiving prenatal stress reduction interventions.(6-8) The stress-reduction intervention proposed in the overarching Promoting Healthy Brains Project (PHBP), the Mothers and Babies course (MB), is a scalable, manualized evidence-based cognitive-behavioral intervention that can be adapted to meet client needs (e.g., setting, dose, timing, modality) without compromising fidelity. However, as there is substantial heterogeneity in maternal responsiveness to prenatal stress-reduction interventions, MB in its current form may be too low-intensity to improve fetal outcomes. Although a few studies have examined impact of interventions like MB on developmental outcomes, the extant evidence base does not provide strong support for intervention effects. Further, state-of-the-art neurodevelopmental methods have not been employed to detect how manipulation of early exposure to stress may effect brain:behavior patterns in early life. Advancing this is the overarching goal of the PHBP.
A crucial component of the proposed work involves an enhanced version of the 12-session, one-on-one version of MB with 1) mindfulness training content; 2) inter-session text messages prompting skills reinforcement, self-monitoring, and homework reminders; 3) adaptive, real-time stress monitoring that will optimize the intervention by identifying the key point at which to deliver just-in-time stress intervention content to individual participants.
The investigators will ask pregnant women to wear a long-wearing, unobtrusive wireless ECG sensor (BioStamp Research Connect; BioStamp). BioStamp sensor data will be used to detect physiological responses to stress (i.e., heart rate variability; HRV) to build a system that can be used to trigger real-time stress reduction intervention. BioStamp, a lightweight, rechargeable, and easy to use wearable device is equipped to passively and continuously measure HRV and motion. Unlike traditional "wired" ECG monitors, BioStamp can be worn under typical daily-living conditions (e.g., sleeping, showering, physical activity), with only minimal obtrusion in daily life (e.g., re-charging, re-applying adhesive).
Led by PI Laurie Wakschlag, the overarching PBHP will harness multidisciplinary expertise from Northwestern's Institute for Innovations in Developmental Sciences (DevSci), Lurie Children's Hospital, Center for Community Health, McCormick School of Engineering, and Feinberg School of Medicine \& Northwestern Medicine (Ob/Gyn, Preventive Medicine, Medical Social Sciences, and Pediatrics) to 1) adapt and pilot MB enhanced with mindfulness training content, and just-in-time feedback to participants regarding their in-the-moment stress responses, and 2) experimentally test the effects of the optimized intervention on maternal wellbeing pre- and postnatally, and postnatal neurodevelopmental health trajectories.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants engaged in the Mothers \& Babies Intervention while wearing a biosensor.
| Arm | Type | Receives |
|---|---|---|
| Mothers and Babies (Enhanced) | Experimental | Behavioral: Mothers and Babies (Enhanced)The course is a manualized stress-reduction intervention with an integrated tech suite designed for timely detection and response to stress. Based on Cognitive-Behavioral Therapy \& attachment theory, MB is divided into 3 sections: Pleasant Activities; Thoughts; Contact with Others. Each module has been enhanced with mindfulness as a strategy to help "center" participants and facilitate practice of skills. Participants receive skills training in each of the three sections as tools to improve and manage their mood. The MB course emphasizes developing \& strengthening the bond with the baby. The technology enhancement includes wearing a BioStamp sensor, and text message-based extra intervention content. Participants get worksheets linked to the 12 sessions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 10-18 weeks gestation
- singleton pregnancy
- receiving prenatal care from a Northwestern University prenatal care clinic \& planning to deliver at Northwestern Hospitals
- English-speaking
- must own a smartphone
Key exclusion criteria (6 listed)
- have known chronic medical or pregnancy 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)
- have significant mental health disorders (e.g., schizophrenia, bipolar disorder, psychosis) which could interfere with study adherence
- 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
- pacemaker or other sensitive medical device
- unable to provide informed consent, complete MB sessions, or complete study assessments in English
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 (Enhanced)The course is a manualized stress-reduction intervention with an integrated tech suite designed for timely detection and response to stress. Based on Cognitive-Behavioral Therapy \& attachment theory, MB is divided into 3 sections: Pleasant Activities; Thoughts; Contact with Others. Each module has been enhanced with mindfulness as a strategy to help "center" participants and facilitate practice of skills. Participants receive skills training in each of the three sections as tools to improve and manage their mood. The MB course emphasizes developing \& strengthening the bond with the baby. The technology enhancement includes wearing a BioStamp sensor, and text message-based extra intervention content. Participants get worksheets linked to the 12 sessions. | Behavioural | Mothers and Babies (Enhanced) |
Primary outcome
Usability/Wearability Feedback
Time frame: At post-intervention (approx. week 13)
Participants will also be asked to provide survey feedback regarding the sensor's usability and wearability, and responding to the Environmental Momentary Assessments (EMAs).
Intervention Acceptability
Time frame: After each of the 12 MB sessions (approx. weekly during weeks 2-13)
All participants will complete a brief intervention rating checklist after completing each MB module (3 total). Additional acceptability information will be ascertained during the exit interview and survey at the end of the intervention to assess participants' overall ratings of the MB course, whether they would recommend the intervention to similar women, and suggestions for intervention modifications.
16 secondary outcomes
Intervention fidelity
Time frame: After each of the 12 MB sessions (approx. weekly during weeks 2-13)
Ecological Momentary Assessment Subjective Stress Ratings
Time frame: Five times daily for approx. weeks 1-13, and one week per month afterward until birth
Objective stress response
Time frame: Continuously during the intervention (approx. weeks 2-13)
Perceived Stress (State Trait Anxiety Inventory)
Time frame: Day 1, post-intervention (approx. week 13), 1 month prior to, and 1 month after delivery
Perceived Stress (Life events scale distress rating)
Time frame: Day 1, post-intervention (approx. week 13), 1 month prior to, and 1 month after delivery
Perceived Stress (Perceived stress scale)
Time frame: Day 1, post-intervention (approx. week 13), 1 month prior to, and 1 month after delivery
Depression symptoms (behavioral activation depression scale)
Time frame: Day 1, post-intervention (approx. week 13), 1 month prior to, and 1 month after delivery
Perceived stress (Prenatal Distress Questionnaire)
Time frame: Day 1, post-intervention (approx. week 13), 1 month prior to, and 1 month after delivery
Depression symptoms (PROMIS depression)
Time frame: Day 1, post-intervention (approx. week 13), 1 month prior to, and 1 month after delivery
Depression symptoms (negative mood regulation scale)
Time frame: Day 1, post-intervention (approx. week 13), 1 month prior to, and 1 month after delivery
Depression symptoms (MOS social support survey)
Time frame: Day 1, post-intervention (approx. week 13), 1 month prior to, and 1 month after delivery
Depression symptoms (Experiences Questionnaire)
Time frame: Day 1, post-intervention (approx. week 13), 1 month prior to, and 1 month after delivery
Depression symptoms (Edinburgh depression scale)
Time frame: Day 1, post-intervention (approx. week 13), 1 month prior to, and 1 month after delivery
Depression symptoms (Prenatal Health Behavior Scale)
Time frame: Day 1, post-intervention (approx. week 13), 1 month prior to, and 1 month after delivery
Intervention skills (five facet mindfulness questionnaire)
Time frame: Day 1, post-intervention (approx. week 13), 1 month prior to, and 1 month after delivery
Intervention skills (MB skills use survey)
Time frame: Day 1, post-intervention (approx. week 13), 1 month prior to, and 1 month after delivery
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 4 Oct 2021.
- 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.
- Individual participant dataSharing planned: No
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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 S Wakschlag, PhD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mothers and Babies (Enhanced) in people with Pregnancy and Prenatal Stress, run by Northwestern University at 1 site in United States.
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 6 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 4 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Usability/Wearability Feedback (time frame: At post-intervention (approx. week 13)). The study lists 2 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 NCT03615261, which also lists 8 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 4 Oct 2021.