Biological Biomarkers in MOMS Partnership

Psychological Stress Clinical Trial

Official title:

Biological Biomarkers in MOMS Partnership

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02438514
• Other study ID #: 1410014845
• Status: Terminated
• Start date: November 2014
• Est. completion date: November 2019

Study information

• Verified date: March 2020
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The investigators propose to evaluate the potential utility of stress-related biomarkers obtained via dried blood spots (DBS) and retinal scans by collecting new data from mothers and children within the New Haven MOMS Partnership, a well-established community-partnered research setting. The proposed research could greatly advance the application of stress-related biomarkers within community-based research by increasing our understanding of how stress, trauma, and depression influence biology in childhood and adulthood, as measured using minimally-invasive approaches.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: November 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 70 Years

Eligibility

Inclusion Criteria:

• English-speaking adult mothers (age 21 or older) of at least one biological child mothers must be able to answer three verification questions to confirm they are the biological parent of their child

Exclusion Criteria:

• Non-english speakers

• Women not able to provide informed consent and with no biological children

• Mothers under the age of 21

Related Conditions & MeSH terms

• Psychological Stress
• Stress, Psychological

Intervention

Other:
• Biological Sample Collection
Anthropomorphic biomarkers including height, weight, heart rate, and blood pressure will be taken for each participating mother and child by a research assistant trained to accurately perform these procedures. Blood spots will be collected in finger stick proficiency, using trigger activated lancets to administer finger sticks. Each participating mothers and child will provide a saliva sample using Oragene DNA saliva collection kits

Locations

Country	Name	City	State
United States	Yale University	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Mother-Child Dyads Who Complete Assessments & Biological Samples	Feasibility outcome	End of study (approximately 5 years)
Primary	Telomere Length	Telomere length will be measured using an adapted method of the Cawthon Telomere Assay	At baseline-After 90 minutes
Primary	Advanced Glycation End Products (AGEs)	AGEs or (advanced glycation endproducts) will be measured using a painless non- invasive retinal scanning device that measures autofluorescence of the crystalline lens of the eye	At baseline-After 90 minutes