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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
12 Years to 18 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at links between changes in the time between heartbeats, managing emotions, and relationships with parents. It is for teens ages 12–18 with major depression. Teens will wear a Fitbit Charge 5 while sleeping for 7 nights and answer questions about their emotions and relationships.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 12–18 and have current major depression recorded by a licensed clinician and confirmed using a parent form.
  • Live with a parent or legal guardian at least half the time.
  • Agree to take part, with a parent or legal guardian who gives permission.
  • Be willing to wear a Fitbit Charge 5 for 7 nights and sync it with a compatible smartphone.
  • Complete all required surveys, body measurements, and caffeine logs, and attend two in-person visits.
  • Have a main caregiver who is willing to take part and complete a relationship survey.
  • If taking medicine for depression, have taken the same dose for at least 4 weeks before screening.
  • Both the teen and caregiver must speak English.

Who can't join

  • Have a condition that affects heartbeat control: an irregular heartbeat, a heart defect present at birth, heart muscle disease, diabetes, a thyroid disorder, or moderate-to-severe sleep apnea (breathing pauses during sleep).
  • Take medicines that affect heart rate, including beta-blockers, calcium channel blockers, heart rhythm medicines, tricyclic antidepressants, stimulants, or antipsychotics.
  • Currently use nicotine, tobacco, alcohol, marijuana, recreational drugs, or energy drinks; or usually have more than 200 mg of caffeine a day.
  • Have a disorder or current symptoms involving loss of touch with reality, or have suicidal thoughts that need immediate help.
  • Have severe problems with thinking or learning that prevent taking part.
  • Have a current eating disorder, such as anorexia, bulimia, or binge eating disorder.
  • Be in another study that uses wearable devices or daily monitoring.
  • Have a skin condition or sensitivity that prevents wearing a wrist device continuously.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 informed consent. 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 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.

Study sites (1)

TX