Psychological StressNCT02438514
Biological Biomarkers in MOMS Partnership
An observational study of Psychological Stress, run by Yale University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Psychological Stress
- What is being tested?
- Biological Sample Collection
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to Nov 2019
- 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 21 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Low-income, racially and ethnically diverse, un- or under-employed, biological mothers of children in New Haven. Primary source of recruitment will be the screening/needs assessment from our affiliated MOMS Partnership protocol, however, we will actively respond to inquiries from any preliminarily eligible biological mother in the New Haven community who expresses interest in the study
Who may be able to join
- 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
Who cannot join
- Non-english speakers
- Women not able to provide informed consent and with no biological children
- Mothers under the age of 21
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Psychological Stress
- Being tested
- Biological Sample Collection
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological Sample CollectionOther
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
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Mother-Child Dyads Who Complete Assessments & Biological Samples
Feasibility outcome
Measured: End of study (approximately 5 years)
Telomere Length
Telomere length will be measured using an adapted method of the Cawthon Telomere Assay
Measured: At baseline-After 90 minutes
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
Measured: At baseline-After 90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2015 (estimated)
- Study startNov 2014
- Primary completionJan 2019
- Study completionNov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological StressStudies of the same condition, open and under way.
- More trials run by Yale 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02438514
- Sponsor's protocol ID
- 1410014845
- Status last verified
- Mar 2020
- First submitted
- 29 Apr 2015
- Last updated
- 12 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biological Biomarkers in MOMS Partnership
- ClinicalTrials.gov ID
- NCT02438514
- Acronym / sponsor ID
- 1410014845
- Conditions
- Psychological Stress
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Jan 2019 (actual)
- Study completion
- Nov 2019 (actual)
- First posted
- 8 May 2015 (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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Low-income, racially and ethnically diverse, un- or under-employed, biological mothers of children in New Haven. Primary source of recruitment will be the screening/needs assessment from our affiliated MOMS Partnership protocol, however, we will actively respond to inquiries from any preliminarily eligible biological mother in the New Haven community who expresses interest in the study
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (3 listed)
- Non-english speakers
- Women not able to provide informed consent and with no biological children
- Mothers under the age of 21
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 |
|---|---|---|
| Biological Sample CollectionAnthropomorphic 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 | Other | – |
Primary outcome
Number of Mother-Child Dyads Who Complete Assessments & Biological Samples
Time frame: End of study (approximately 5 years)
Feasibility outcome
Telomere Length
Time frame: At baseline-After 90 minutes
Telomere length will be measured using an adapted method of the Cawthon Telomere Assay
Advanced Glycation End Products (AGEs)
Time frame: At baseline-After 90 minutes
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
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psychological Stress, run by Yale 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 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: stopped early, as of the sponsor's last update on 12 Mar 2020. 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 was stopped early. Results are not available in the source record.
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?
Number of Mother-Child Dyads Who Complete Assessments & Biological Samples (time frame: End of study (approximately 5 years)). The study lists 3 primary outcomes in all. 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 12 Mar 2020; AzTrials last refreshed its copy on 6 Nov 2026.