StressMIBLSNCT02013401
Transmission of Mother-Infant Stress Communication
An observational study of Stress, run by University of Massachusetts, Boston at 2 sites in United States.
Trial summary
The central aim of this study is to assess mother-infant communication via behavioral, physiological, and affective indices under conditions where distal stressors may not be directly detectable by the infant. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Stress
- How many people
- 56 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2013to 14 Jul 2016
- Phase
- Observational
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Community sample of women (ages 18-40) with infants ages 4-9 months
Who may be able to join
- Healthy volunteers
Who cannot join
- No presence of heart murmur or wear a pacemaker
- No medication for hypertensive or cardiovascular disease
- Not using beta blockers
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Mass. Boston
Boston, Massachusetts, 02125
University of Massachusetts, Boston, Child Development Unit
Boston, Massachusetts, 02125
About this study
Official title: Transmission of Discrimination-Related Stress Reactivity and Reduction From Mother to Infant
The central aim of this study is to assess mother-infant communication via behavioral, physiological, and affective indices under conditions where distal stressors may not be directly detectable by the infant.
Read the detailed description
This investigation examines a distal maternal stressor on the quality of interaction in mother-infant dyadic communication. Assessments include behavioral, physiological, and affective indices under conditions where distal stressors may not be directly detectable by the infant. The present research examines mother-infant interactions to test the hypothesis of whether maternal stress may be transduced to their infants via multiple pathways. The secondary aim is to explore effective emotion regulation strategies for the mother as potential buffers to stress and additionally reducing early life stress effects on the infant's regulatory development.
While the emotion regulation literature posits that reappraisal may be associated with decreased in physiological and psychological stress, this type of regulation strategy may be ineffective when interfacing with discrimination. The regulation strategy needs to be titrated to the stressor in order to be effective. These findings will have notable social, clinical, and psychological significance,
- Conditions
- Stress
- Keywords
- mother-infant dyadic regulation, stress, psychophysiology, emotion regulation
- Medical subject headings
- Emotional Regulation
What is being measured
The primary outcome is the main question the study is designed to answer.
Salivary Cortisol
Salivary cortisol is a measure that indicates hypothalamus-pituitary-adrenal axis activity. The study obtains 4 assessments with 20 minutes between each assessment. Participants chew on a cotton role for 2-minutes which is placed in a cortisol salivette tube (Sarstedt)
Measured: One lab appointment for approximately 80 minutes.
Secondary outcomes (1)
Salivary Amylase
Salivary amylase is an indicator of sympathetic nervous system activity. The same salivary salivette is used to later extract the amylase.
Measured: One lab appointment for approximately 80 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2013 (estimated)
- Study startOct 2013
- Primary completion14 Jul 2016
- Study completion14 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Boston
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kymberlee O'Brien, PhD, Principal investigator, Postdoctoral Research FellowCelia L Moore, PhD, Study director, Director of DSRC and Horizon CenterEdward Tronick, PhD, Study director, Director Child Development Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02013401
- Sponsor's protocol ID
- 2013173
- Acronym
- MIBLS
- Status last verified
- Oct 2018
- First submitted
- 11 Dec 2013
- Last updated
- 18 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transmission of Discrimination-Related Stress Reactivity and Reduction From Mother to Infant
- ClinicalTrials.gov ID
- NCT02013401
- Acronym / sponsor ID
- MIBLS / 2013173
- Conditions
- Stress
- Keywords
- mother-infant dyadic regulation, stress, psychophysiology, emotion regulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University of Massachusetts, BostonUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- 14 Jul 2016 (actual)
- Study completion
- 14 Jul 2016 (actual)
- First posted
- 17 Dec 2013 (estimated)
- 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 central aim of this study is to assess mother-infant communication via behavioral, physiological, and affective indices under conditions where distal stressors may not be directly detectable by the infant.
Detailed description
This investigation examines a distal maternal stressor on the quality of interaction in mother-infant dyadic communication. Assessments include behavioral, physiological, and affective indices under conditions where distal stressors may not be directly detectable by the infant. The present research examines mother-infant interactions to test the hypothesis of whether maternal stress may be transduced to their infants via multiple pathways. The secondary aim is to explore effective emotion regulation strategies for the mother as potential buffers to stress and additionally reducing early life stress effects on the infant's regulatory development.
While the emotion regulation literature posits that reappraisal may be associated with decreased in physiological and psychological stress, this type of regulation strategy may be ineffective when interfacing with discrimination. The regulation strategy needs to be titrated to the stressor in order to be effective. These findings will have notable social, clinical, and psychological significance,
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Community sample of women (ages 18-40) with infants ages 4-9 months
Key inclusion criteria (1 listed)
- Healthy volunteers
Key exclusion criteria (3 listed)
- No presence of heart murmur or wear a pacemaker
- No medication for hypertensive or cardiovascular disease
- Not using beta blockers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Salivary Cortisol
Time frame: One lab appointment for approximately 80 minutes.
Salivary cortisol is a measure that indicates hypothalamus-pituitary-adrenal axis activity. The study obtains 4 assessments with 20 minutes between each assessment. Participants chew on a cotton role for 2-minutes which is placed in a cortisol salivette tube (Sarstedt)
1 secondary outcome
Salivary Amylase
Time frame: One lab appointment for approximately 80 minutes.
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 18 Oct 2018.
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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.
Kymberlee O'Brien, PhD principal investigator
Postdoctoral Research Fellow
Celia L Moore, PhD study director
Director of DSRC and Horizon Center
Edward Tronick, PhD study director
Director Child Development Unit
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stress, run by University of Massachusetts, Boston at 2 sites 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 1 inclusion and 3 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 18 Oct 2018. 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?
Salivary Cortisol (time frame: One lab appointment for approximately 80 minutes.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Oct 2018.