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Completed

NCT Number: NCT04298944

Association of Mood With Risk for Atherosclerosis

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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Key information

Age range

Up to 22 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Johns Hopkins School of Medicine Division of Pediatric Nephrology

Baltimore, Maryland, 21287, United States

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Cardiovascular Assessments

Diagnostic Test

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

Actigraphy

Diagnostic Test

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

Laboratory assessments

Diagnostic Test

Participants will provide blood and urine samples for laboratory assessments.

Emotional/ Behavioural assessments

Behavioral

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)

Primary outcomes

  1. Arterial stiffness as assessed by Pulse wave velocity

    Time frame: 1 day

    This will be determined from Pulse wave velocity (m/sec) done at the study visit

  2. Arterial stiffness as assessed by Ambulatory Arterial Stiffness Index (AASI)

    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.

  3. Arterial stiffness as assessed by Augmentation Index

    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.

  4. Endothelial function as assessed by Laser Doppler flow perfusion

    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.

  5. Mean Blood pressure (mmHg)

    Time frame: 1 day

    Mean daytime systolic blood pressure in millimeters of mercury (mmHg) will be determined from 24-hour blood pressure monitoring.

Secondary outcomes

  1. Pediatric Adverse Childhood Events (ACEs) score

    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.

  2. Children's Emotion Management Scale (CEMS) score

    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.

  3. Behavior Assessment for Children (BASC) score

    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.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

AuRA Study: Association of Mood With Risk for Atherosclerosis

Acronym: AuRA

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Mar 6, 2020
Registry last updated
Aug 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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