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Association of Mood With Risk for Atherosclerosis

AuRA Study: Association of Mood With Risk for Atherosclerosis

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04298944
Acronym
AuRA
Enrollment
37
Registered
2020-03-06
Start date
2020-03-11
Completion date
2022-05-31
Last updated
2022-08-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mood Disorders, Hypertension, Overweight and Obesity, Vascular Stiffness, Sleep, Elevated Blood Pressure

Brief summary

The investigators will aim to determine the association of mood disorders (MDO) with preclinical and clinical cardiovascular (CVD) risk factors among children. The investigators will also aim to identify traditional and non traditional predictors of CVD risk among children with MDO.

Detailed description

This research is being done to determine if mood disorders in children have an impact on stiffness of arteries and/or cause the arteries to not work as well and if MDOs impact blood pressure over a 24 hour period of time.The investigators also want to determine if children with mood disorders have any risk factors or blood tests that can predict how stiff arteries are or how well arteries function and if these are associated with cardiovascular disease risk. The investigators also want to determine if children with mood disorders have greater adverse childhood experiences, worse emotional regulation and poorer quality of sleep. The investigators hope that information from this study could help in earlier detection of cardiovascular disease risk in children.

Interventions

Participants will undergo the following cardiovascular assessments: 24-hour blood pressure monitoring, arterial stiffness measurements, endothelial function measurements.

DIAGNOSTIC_TESTActigraphy

Participants will wear an actigraph device for 7 days to measure participant's activity and sleep

DIAGNOSTIC_TESTLaboratory assessments

Participants will provide blood and urine samples for laboratory assessments.

BEHAVIORALEmotional/ Behavioural assessments

Emotional /Behavioral well being will be determined by questionnaires: Pediatrics Adverse Childhood Experiences Questionnaire (ACEs Q), Childrens Emotion Management Scale Questionnaire (CEMS) and Behavior Assessment System for Children (BASC)

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
Johns Hopkins University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
No minimum to 22 Years

Inclusion criteria

* Children Ages ≤ 22 years old * Enrolled in the CHAMPION Trial and have agreed to be contacted for future studies or children who visit PMP clinic and have MDO and a healthy weight or participants in the Be-HealthY Cohort whose data indicate no history of MDO.

Exclusion criteria

* Not able to speak English * Unable to lie supine * Significant Arrhythmia * If participant has used vaso-active drugs the morning of the test (tobacco, caffeine decongestants, or asthma medications).

Design outcomes

Primary

MeasureTime frameDescription
Mean Blood pressure (mmHg)1 dayMean daytime systolic blood pressure in millimeters of mercury (mmHg) will be determined from 24-hour blood pressure monitoring.
Arterial stiffness as assessed by Ambulatory Arterial Stiffness Index (AASI)1 dayThe Ambulatory Arterial Stiffness Index will be determined from data obtained from vascular measures and during 24-hour ambulatory blood pressure monitoring. Arterial stiffness increases as the regression slope approaches 0 and the AASI approaches 1.
Arterial stiffness as assessed by Augmentation Index1 dayThe Augmentation Index (measured as a percentage) will be determined from a vascular assessment and data obtained during 24-hour ambulatory blood pressure monitoring. A greater Augmentation Index represents a stiffer, less compliant vessel.
Endothelial function as assessed by Laser Doppler flow perfusion1 dayThe percent change in mean blood flow will be determined from Laser Doppler flow perfusion measurements obtained using a heating protocol.
Arterial stiffness as assessed by Pulse wave velocity1 dayThis will be determined from Pulse wave velocity (m/sec) done at the study visit

Secondary

MeasureTime frameDescription
Children's Emotion Management Scale (CEMS) score1 dayThe Children's Emotional management scale is a questionnaire that consists of 33 questions (3 point Likert scale) examining youth's ability to regulate appropriately the youth's negative emotions (i.e. anger, sadness, and worry). Generally, poorer emotion regulation capabilities are associated with poorer health outcomes, with most research looking at CV outcomes in adults.
Behavior Assessment for Children (BASC) score1 dayThe Behavior Assessment for Children is a questionnaire that consists of 189 questions (True/False and 4 point Likert scale). It is a broad behavioral screening measure commonly used in child and adolescent psychology and psychiatric settings.It has three primary scales: internalizing (e.g., depression, anxiety), externalizing (e.g., aggression, hyperactivity), and total problems (combination of internalizing and externalizing plus attention problems and withdrawal subscales). Scores between 60-69 are considered at risk for clinical problems and scores of 70+ are considered clinically significant presence of those symptoms. Any scores that are not in this range are considered to be within normal limits and not indicative of difficulties.
Pediatric Adverse Childhood Events (ACEs) score1 dayThe Pediatric ACEs questionnaire contains 17 yes or no questions about stressful or traumatic life events. Greater exposure to adverse childhood experiences (ACEs) is associated with poorer physical and mental health. Some researchers have suggested that an ACEs score of greater than or equal to 3 or 4 significantly increases the risk for health problems, however, there is no widely accepted threshold for how many ACEs endorsed is clinically significant or more predictive of these problems.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026