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Teen depression study tracks heartbeats and family bonds

NCT ID NCT07430774

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at how heart rate variability (a measure of stress response) relates to emotional control and parent-teen relationships in 74 adolescents with depression. Teens will wear a Fitbit while sleeping for a week and fill out questionnaires. The goal is to better understand these connections, not to test a treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 74 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

12 to 18 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

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

    Dallas, Texas, 75247, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.