Johns Hopkins School of Medicine Division of Pediatric Nephrology
Baltimore, Maryland, 21287, United States
NCT Number: NCT04298944
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.
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Notify MeUp to 22 year
All sexes
Observational
Baltimore, Maryland, 21287, United States
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.
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will undergo the following cardiovascular assessments: 24-hour blood pressure monitoring, arterial stiffness measurements, endothelial function measurements.
Participants will wear an actigraph device for 7 days to measure participant's activity and sleep
Participants will provide blood and urine samples for laboratory 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)
Time frame: 1 day
This will be determined from Pulse wave velocity (m/sec) done at the study visit
Time frame: 1 day
The 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.
Time frame: 1 day
The 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.
Time frame: 1 day
The percent change in mean blood flow will be determined from Laser Doppler flow perfusion measurements obtained using a heating protocol.
Time frame: 1 day
Mean daytime systolic blood pressure in millimeters of mercury (mmHg) will be determined from 24-hour blood pressure monitoring.
Time frame: 1 day
The 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.
Time frame: 1 day
The 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.
Time frame: 1 day
The 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.
Johns Hopkins University
Other
AuRA Study: Association of Mood With Risk for Atherosclerosis
Acronym: AuRA
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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