- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02013401
Transmission of Mother-Infant Stress Communication (MIBLS)
Transmission of Discrimination-Related Stress Reactivity and Reduction From Mother to Infant
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02125
- University of Mass. Boston
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Boston, Massachusetts, United States, 02125
- University of Massachusetts, Boston, Child Development Unit
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Healthy volunteers
Exclusion Criteria:
- No presence of heart murmur or wear a pacemaker
- No medication for hypertensive or cardiovascular disease
- Not using beta blockers
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Salivary Cortisol
Time Frame: One lab appointment for approximately 80 minutes.
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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)
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One lab appointment for approximately 80 minutes.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Salivary Amylase
Time Frame: One lab appointment for approximately 80 minutes.
|
Salivary amylase is an indicator of sympathetic nervous system activity.
The same salivary salivette is used to later extract the amylase.
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One lab appointment for approximately 80 minutes.
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mother-infant observations
Time Frame: One lab appointment for approximately 80 minutes.
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At four assessment occasions during the one time visit, the mother and infant are observed for a free 2-minute period.
Observations include global affect, and (present or not) vocalizations, infant fussiness, and motor activity.
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One lab appointment for approximately 80 minutes.
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Collaborators and Investigators
Investigators
- Principal Investigator: Kymberlee O'Brien, PhD, Postdoctoral Research Fellow
- Study Director: Celia L Moore, PhD, Director of DSRC and Horizon Center
- Study Director: Edward Tronick, PhD, Director Child Development Unit
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2013173
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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