Association of Mood With Risk for Atherosclerosis (AuRA)
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ClinicalTrials.gov Identifier: NCT04298944 |
Recruitment Status :
Recruiting
First Posted : March 6, 2020
Last Update Posted : August 5, 2021
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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.
Condition or disease | Intervention/treatment |
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Mood Disorders Hypertension Overweight and Obesity Vascular Stiffness Sleep Elevated Blood Pressure | Diagnostic Test: Cardiovascular Assessments Diagnostic Test: Actigraphy Diagnostic Test: Laboratory assessments Behavioral: Emotional/ Behavioural assessments |
Study Type : | Observational [Patient Registry] |
Estimated Enrollment : | 80 participants |
Observational Model: | Other |
Time Perspective: | Cross-Sectional |
Target Follow-Up Duration: | 7 Days |
Official Title: | AuRA Study: Association of Mood With Risk for Atherosclerosis |
Actual Study Start Date : | March 11, 2020 |
Estimated Primary Completion Date : | August 1, 2022 |
Estimated Study Completion Date : | August 1, 2022 |

Group/Cohort | Intervention/treatment |
---|---|
BeHealthY Cohort
Children from BeHealthY cohort who are obese/overweight but do not have mood disorders are eligible for this study. The children will be given additional questionnaires to assess emotional/behavioral well being.
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Diagnostic Test: Cardiovascular Assessments
Participants will undergo the following cardiovascular assessments: 24-hour blood pressure monitoring, arterial stiffness measurements, endothelial function measurements. Diagnostic Test: Actigraphy Participants will wear an actigraph device for 7 days to measure participant's activity and sleep Diagnostic Test: Laboratory assessments Participants will provide blood and urine samples for laboratory assessments. Behavioral: Emotional/ 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) |
CHAMPION trial Cohort
Children who are overweight/obese and have severe mental illness, and who have agreed to be contacted for future research. Tests will be done on all participants which includes cardiovascular assessments, actigraphy, laboratory assessments and emotional/behavioral assessments. |
Diagnostic Test: Cardiovascular Assessments
Participants will undergo the following cardiovascular assessments: 24-hour blood pressure monitoring, arterial stiffness measurements, endothelial function measurements. Diagnostic Test: Actigraphy Participants will wear an actigraph device for 7 days to measure participant's activity and sleep Diagnostic Test: Laboratory assessments Participants will provide blood and urine samples for laboratory assessments. Behavioral: Emotional/ 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) |
Pediatric Medical Psychiatric (PMP) Clinic Cohort
Children from the PMP Clinic who have severe mental illness but healthy weight. Tests will be done on all participants which includes cardiovascular assessments, actigraphy, laboratory assessments and emotional/behavioral assessments.
|
Diagnostic Test: Cardiovascular Assessments
Participants will undergo the following cardiovascular assessments: 24-hour blood pressure monitoring, arterial stiffness measurements, endothelial function measurements. Diagnostic Test: Actigraphy Participants will wear an actigraph device for 7 days to measure participant's activity and sleep Diagnostic Test: Laboratory assessments Participants will provide blood and urine samples for laboratory assessments. Behavioral: Emotional/ 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) |
- 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
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.

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Ages Eligible for Study: | up to 22 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Sampling Method: | Non-Probability Sample |
Children and young adults up to 22 years of age who belong to either of the following groups:
- overweight/obese and no history of mood disorders
- overweight/obese with a mood disorder
- not overweight/obese with a mood disorder
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).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04298944
Contact: Tammy M Brady, M.D, PhD | 4109552467 | tbrady8@jhmi.edu | |
Contact: Gilbert A Horst, B.A, B.S | ghorst1@jhmi.edu |
United States, Maryland | |
Johns Hopkins School of Medicine Division of Pediatric Nephrology | Recruiting |
Baltimore, Maryland, United States, 21287 | |
Contact: Tammy M Brady, M.D, PhD 410-955-2467 tbrady8@jhmi.edu | |
Principal Investigator: Tammy M Brady, M.D, PhD |
Principal Investigator: | Tammy M Brady, M.D, PhD | Johns Hopkins University |
Responsible Party: | Johns Hopkins University |
ClinicalTrials.gov Identifier: | NCT04298944 |
Other Study ID Numbers: |
IRB00226838 P50MH115842-01 ( U.S. NIH Grant/Contract ) |
First Posted: | March 6, 2020 Key Record Dates |
Last Update Posted: | August 5, 2021 |
Last Verified: | August 2021 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Hypertension Atherosclerosis Overweight Mood Disorders Vascular Diseases |
Cardiovascular Diseases Body Weight Arteriosclerosis Arterial Occlusive Diseases Mental Disorders |