Stress Clinical Trial
— MIBLSOfficial title:
Transmission of Discrimination-Related Stress Reactivity and Reduction From Mother to Infant
| NCT number | NCT02013401 |
| Other study ID # | 2013173 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | October 2013 |
| Est. completion date | July 14, 2016 |
| Verified date | October 2018 |
| Source | University of Massachusetts, Boston |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 56 |
| Est. completion date | July 14, 2016 |
| Est. primary completion date | July 14, 2016 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 18 Years to 40 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Mass. Boston | Boston | Massachusetts |
| United States | University of Massachusetts, Boston, Child Development Unit | Boston | Massachusetts |
| Lead Sponsor | Collaborator |
|---|---|
| University of Massachusetts, Boston |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Mother-infant observations | 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. | One lab appointment for approximately 80 minutes. | |
| Primary | 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) | One lab appointment for approximately 80 minutes. | |
| Secondary | Salivary Amylase | Salivary amylase is an indicator of sympathetic nervous system activity. The same salivary salivette is used to later extract the amylase. | One lab appointment for approximately 80 minutes. |
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