Emotional DysregulationCONNECTNCT07430774
Parent-Adolescent Relationships, Emotional Regulation, and HRV in Adolescents With Depression
An observational study of Emotional Dysregulation and HRV, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Emotional Dysregulation, HRV, Adolescent
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2026to 1 May 2027
- How long will I take part?
- 1 Week
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Child and adolescent psychiatrist at the Children's Health Psychiatry Clinic.
Dallas, Texas, 75247
Emine Rabia Ayvaci, Psyquiatric, 650-804-0602, Emine.Ayvaci@utsouthwestern.edu
About this study
Official title: CONNECT Study: 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.
- Conditions
- Emotional Dysregulation, HRV, Adolescent, Family Relationship, Depression
- Medical subject headings
- Depression
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 7 consecutive days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study startNov 2026 (estimated)
- Primary completion1 Apr 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emotional DysregulationStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 74 participants (estimated)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rabia Ayvaci, University of Texas Southwestern Medical Center
- Investigators
- Emine Ayvaci, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07430774
- Sponsor's protocol ID
- STU20252634
- Acronym
- CONNECT
- Status last verified
- Sep 2026
- First submitted
- 17 Feb 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CONNECT Study: Parent-Adolescent Relationships, Emotional Regulation, and HRV in Adolescents With Depression
- ClinicalTrials.gov ID
- NCT07430774
- Acronym / sponsor ID
- CONNECT / STU20252634
- Conditions
- Emotional Dysregulation, HRV, Adolescent, Family Relationship, Depression
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 24 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Week
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (9 listed)
- 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).
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Resting Heart Rate (RHR)
Time frame: 7 consecutive days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Emine Ayvaci principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Emotional Dysregulation and HRV, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emine Rabia Ayvaci, MD (650-804-0602, Emine.Ayvaci@utsouthwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nighttime Heart Rate Variability (RMSSD) (time frame: 7 consecutive days and nights). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.