Not Yet RecruitingNot Applicable

Parent-Adolescent Relationships, Emotional Regulation, and HRV in Adolescents With Depression

United States74 participantsStarted 2026-07-01

Plain-language summary

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.

Who can participate

Age range12 Years – 18 Years

SexALL

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Inclusion criteria

✓. 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.
✓. Willingness to comply with all study procedures, including wearing a Fitbit Charge 5 for 7 nights, syncing the device through a compatible smartphone, and completing all required assessments (DERS-36, PHQ-9, anthropometrics, Youth Activity Profile, caffeine logs, PACHIQ-R).
✓. Primary caregiver willing to participate, including completion of the PACHIQ-R (Caregiver).
✓. If taking antidepressant medication, must be on a stable dose for at least 4 weeks before screening, verified on the Self-Administered Comorbidity Questionnaire.
✓. English-speaking adolescent and caregiver, as all measures used in the study are validated in English.

Exclusion criteria

What they're measuring

Nighttime Heart Rate Variability (RMSSD)

Timeframe: 7 consecutive days and nights

Trial details

NCT IDNCT07430774

SponsorUniversity of Texas Southwestern Medical Center

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-04-01

Contact for this trial

Emine Rabia Ayvaci, MD

650-804-0602 Emine.Ayvaci@utsouthwestern.edu

View on ClinicalTrials.gov More Emotional Dysregulation trials