ClinicalTrials.gg
RecruitingNCT07430774CONNECTUpdated Sep 21, 2026

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

An observational study in Emotional Dysregulation, HRV and Adolescent, sponsored by University of Texas Southwestern Medical Center. Recruiting at 1 site in United States. Open to participants aged 12 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-09-21.

Sponsored by University of Texas Southwestern Medical Center · Observational

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Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
74
Ages
12 Years to 18 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 47 studies in Depression by University of Texas Southwestern Medical Center — 6 open to participants now, 9 under way, none of them phase 3. Depression · University of Texas Southwestern Medical Center.

Planned enrollment
8th of 10
74 · median 744
Started
2026
with 2 others
Observational
10 of 47
2 open now
Registered
46th of 47
by date

Among the 47 studies in Depression by University of Texas Southwestern Medical Center, this one is the 8th largest by planned enrollment of the 10 observational ones that give a count, is one of 3 that started in 2026, is one of 10 observational ones, and was the 46th registered.

Depression

8,582 studies on the registry are indexed under Depression; 1,723 are open to participants now.

Browse Depression studies →

Open to participants now

6 of the 47 studies in Depression by University of Texas Southwestern Medical Center are open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

All 6 open studies →

Where they have run

Who these studies take

Of the 1,089 Depression studies recruiting now, 470 (43%) set no upper age limit and 519 (48%) stop at 75 or younger; 203 take children under 18; 311 take healthy volunteers.

This study: 12 Years to 18 Years · all sexes · no healthy volunteers.

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02

Study 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.

03

Conditions studied

  • Emotional Dysregulation
  • HRV
  • Adolescent
  • Family Relationship
  • Depression

Browse trials for

04

Who can participate

Ages eligible
12 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Aged 12-18 years at the time of screening.
  2. Current Major Depressive Disorder (MDD) documented in the electronic medical record by a licensed clinician; diagnosis verified using the Mental Health History - Parent Form.
  3. Lives with a parent/legal guardian at least 50% of the time, confirmed on the Demographics Form.
  4. Able and willing to provide assent, with a parent/legal guardian able and willing to provide .
  5. 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).
  6. Primary caregiver willing to participate, including completion of the PACHIQ-R (Caregiver).
  7. If taking antidepressant medication, must be on a stable dose for at least 4 weeks before screening, verified on the Self-Administered Comorbidity Questionnaire.
  8. English-speaking adolescent and caregiver, as all measures used in the study are validated in English.
  9. Available for two in-person study visits within the study period.

Exclusion criteria

Exclusion Criteria

  1. 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.
  2. 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.
  3. Active substance use, including nicotine/tobacco, alcohol, marijuana, recreational drugs, or energy drinks, as assessed by the Drug Use Screening Inventory.
  4. 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.
  5. Psychotic disorders or active psychotic symptoms, as reported on the Mental Health History Questionnaire (Parent) and the Self-Administered Comorbidity Questionnaire.
  6. 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.
  7. 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.
  8. Current eating disorder diagnosis (anorexia nervosa, bulimia nervosa, or binge eating disorder), as reported on the Mental Health History Questionnaire.
  9. Concurrent participation in another study involving wearable devices or daily monitoring, as reported on the Eligibility Screening Form.
  10. Skin conditions or sensitivities prevent continuous wear of a wrist-worn device reported on the Eligibility Screening Form.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
74 participants (estimated)
Target follow-up
1 Week
Patient registry
Yes
06

What researchers measure

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 nights

Secondary 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 days

07

Study locations

1 of 1 sites recruiting
  • Child and adolescent psychiatrist at the Children's Health Psychiatry Clinic.
    Dallas, Texas 75247, United States
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Nov 2026; primary completion for Apr 2027, 5 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 17, 2026
First posted
Feb 24, 2026
StartEst.
Nov 2026
Primary completionEst.
Apr 1, 2027
CompletionEst.
May 1, 2027
Last update
Sep 21, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07430774
Responsible party
Rabia Ayvaci (Assistant Professor, University of Texas Southwestern Medical Center) — Principal investigator
First posted
Feb 24, 2026
Start date
Nov 2026 (estimated)
Primary completion
Apr 1, 2027 (estimated)
Completion
May 1, 2027 (estimated)
Last update
Sep 21, 2026

Study contacts

Emine Rabia Ayvaci, MD
Contact
Emine.Ayvaci@utsouthwestern.edu
650-804-0602
Yosanly Cornelio Puello, MD
Contact
yosanly.corneliopuello@UTSouthwestern.edu
8576158475
Emine Ayvaci
principal investigator · University of Texas Southwestern Medical Center

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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