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NCT Number: NCT07430774

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

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.

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Key information

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Dallas, Texas, 75247, United States

Location contact

Emine Rabia Ayvaci, Psyquiatric

CONTACT

[email protected]

650-804-0602

Who can participate

Healthy volunteers accepted: No

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

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

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. Nighttime Heart Rate Variability (RMSSD)

    Time frame: 7 consecutive days and nights

    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.

Secondary outcomes

  1. Resting Heart Rate (RHR)

    Time frame: 7 consecutive days

    Average resting heart rate (beats per minute) derived from wearable device data, reflecting baseline autonomic arousal and physiological stress.

Study contacts

Contact information is provided by the study sponsor or research team.

Emine Rabia Ayvaci, MD

CONTACT

[email protected]

650-804-0602

Yosanly Cornelio Puello, MD

CONTACT

[email protected]

8576158475

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Official study title

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

Acronym: CONNECT

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 24, 2026
Registry last updated
May 6, 2026

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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