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

NCT07430774 | Not Yet Recruiting

• 1 other identifier: STU20252634
• Study Type: observational
• Target: 74
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Emotional Dysregulation; HRV; Adolescent; Family Relationship; Depression

Outcome Measures

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.

  7 consecutive days and nights

Secondary Outcomes (1)

• Resting Heart Rate (RHR)

  7 consecutive days

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.
• Available for two in-person study visits within the study period.

You may not qualify if:

• 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.
• Psychotic disorders or active psychotic symptoms, as reported on the Mental Health History Questionnaire (Parent) and the Self-Administered Comorbidity Questionnaire.
• Acute suicidal ideation requiring immediate intervention, defined as endorsement of agree and strongly agree on items 14-16 of the Concise Health Risk Tracking Self-Report (CHRT-SR), indicating active suicide risk.
• Severe cognitive or intellectual impairment interfering with study participation, determined during eligibility screening based on parent report on the Mental Health History Questionnaire and observed inability to complete screening or consent procedures.
• Current eating disorder diagnosis (anorexia nervosa, bulimia nervosa, or binge eating disorder), as reported on the Mental Health History Questionnaire.
• Concurrent participation in another study involving wearable devices or daily monitoring, as reported on the Eligibility Screening Form.
• Skin conditions or sensitivities prevent continuous wear of a wrist-worn device reported on the Eligibility Screening Form.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

Child and adolescent psychiatrist at the Children's Health Psychiatry Clinic.

Dallas, Texas, 75247, United States

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Central Study Contacts

Emine Rabia Ayvaci, MD

CONTACT

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

Yosanly Cornelio Puello, MD

CONTACT

8576158475; yosanly.corneliopuello@UTSouthwestern.edu

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Week
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 17, 2026
• First Posted: February 24, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-04

Locations

US (1)