Parent-Adolescent Relationships, Emotional Regulation, and HRV in Adolescents With Depression
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age12-18
SponsorUniversity of Texas Southwestern Medical Center
About this trial
This cross-sectional study examines associations among heart rate variability (HRV), emotional dysregulation, and parent-adolescent relationship quality in adolescents with Major Depressive Disorder (MDD). We hypothesize that lower HRV will be linked to greater emotional dysregulation and that more supportive parent-adolescent relationships will correlate with higher HRV. Participants will wear a Fitbit Charge 5 during nighttime sleep for 7 consecutive nights and complete validated measures of emotional regulation and relationship quality.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged 12-18 years at the time of screening.
Current Major Depressive Disorder (MDD) documented in the electronic medical record by a licensed clinician; diagnosis verified using the Mental Health History - Parent Form.
Lives with a parent/legal guardian at least 50% of the time, confirmed on the Demographics Form.
Able and willing to provide assent, with a parent/legal guardian able and willing to provide informed consent.
Disqualifiers
Medical conditions affecting autonomic function or HRV (arrhythmia, congenital heart disease, cardiomyopathy, Type 1 or Type 2 diabetes, thyroid disorders, or moderate-to-severe sleep apnea), as reported on the Self-Administered Comorbidity Questionnaire.
Use of medications known to affect heart rate or HRV, including beta-blockers, calcium channel blockers, antiarrhythmics, tricyclic antidepressants, stimulants, or antipsychotics, as documented on the NIMH Concomitant Medication Log.
Active substance use, including nicotine/tobacco, alcohol, marijuana, recreational drugs, or energy drinks, as assessed by the Drug Use Screening Inventory.
Habitual high caffeine intake (>200 mg/day, equivalent to >4 cups of coffee or >2 cans of caffeinated soda per day), as assessed by a caffeine screening question during eligibility screening.
Trial population
The study will enroll 74 adolescents (ages 12-18 years) diagnosed with MDD and their primary caregivers. Participants must live with a caregiver for ≥50% of the time. Recruitment will occur through Children's Medical Center Dallas and will reflect the racial and ethnic diversity of the Dallas-Fort Worth area.
Trial design
Design model
Other
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Nighttime Heart Rate Variability (RMSSD)
Average nighttime RMSSD reflecting parasympathetic autonomic activity, passively collected via wearable device during sleep. Emotional dysregulation assessed as a continuous predictor using the DERS-36 total score.
Time frame
7 consecutive days and nightsSecondary outcomes
1
Resting Heart Rate (RHR)
Average resting heart rate (beats per minute) derived from wearable device data, reflecting baseline autonomic arousal and physiological stress.
Time frame
7 consecutive daysSponsors and contacts
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Source ClinicalTrials.gov