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Stress Dynamics and Familial Risk for Depression in Female Adolescents

Tracking the Dynamic Trajectory of Behavioral, Physiological, and Neurobiological Stress Responses in Female Adolescents at High and Low Familial Risk for 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
13 Years to 15 Years
Sex
Female only
Healthy volunteers
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

  • Procedures mentioned: Questionnaires, Interviews, MRI scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The study will include five sessions over the span of 18-months, including: * A clinical diagnostic interview as well as filling out a series of questionnaires and assessments."
  • "This can be done virtually over Zoom or in-person. * The second session will include a functional magnetic resonance imaging (fMRI) brain scan to be conducted at the McLean Hospital Imaging Center."
  • "Participants will be asked to respond to surveys on their cell phone in the two-weeks following the fMRI brain scan."
  • "Participants will also be given and asked to wear a smartwatch that tracks their heart rate, activity level, and sleep patterns for two-weeks. * The third session will include a diagnostic interview, assessments, and questionnaires to be completed six-months after the fMRI brain scan."
  • "Participants will be asked to complete surveys on their cell phone during the two-weeks following this six month follow-up session."
  • "Participants will also be given and asked to wear a smartwatch that tracks their heart rate, activity level, and sleep patterns for two-weeks. * The fourth session will include a diagnostic interview, assessments, and questionnaires to be completed 12-months after the fMRI brain scan."
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 how the brain and body respond to stress in teens ages 13–15 who were assigned female at birth, with or without a parent who has had major depression. It uses brain scans, smartphones, and smartwatches to track stress and signs of depression. Researchers want to learn whether brain responses to stress can help predict future depression.

Stress and a parental history of major depressive disorder (MDD) are among the strongest risk factors for future development of MDD. Studies have shown that having a parental history of MDD may be associated with behavioral, psychophysiological, and hormonal responses to stress that are associated with poorer stress coping. . Adolescence is a vulnerable developmental window linked to increased MDD risk, especially for females, as rates of MDD surge relative to males. Despite the central role of stress in MDD onset, little is known about the brain mechanisms underlying stress responses in susceptible female adolescents at high familial risk for MDD. Also, it is unclear how stress-related brain network alterations may relate to "real-world" maladaptive stress responses and whether these stress-related brain network changes are predictive of future depression onset. We will fulfill these research gaps by combining neuroimaging with intensive longitudinal tracking of depressive symptomology as well as behavioral and physiological responses to "real world" stress using smartphone and smartwatch technology. Elucidating these neural mechanisms may aid in the discovery of MDD biomarkers that could identify youth at greatest risk for future MDD development and lead to earlier intervention efforts.

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

Eligibility

Who can join

  • Assigned female at birth and ages 13–15.
  • Speak English fluently or as a first language.
  • Right-handed.
  • Have a personal cell phone to answer study questions during daily life.
  • Able to sign a form agreeing to take part, on paper or online.
  • Have normal vision and hearing, with correction if needed.
  • For the high-risk group: have a biological parent who has had at least one episode of major depression.

Who can't join

  • Cannot safely have an MRI brain scan because of certain metal objects, implants, devices, tattoos, or skin patches.
  • Have a medical or brain condition that could affect brain scan results, or an underactive or overactive thyroid.
  • Use hormone replacement therapy or anabolic steroids, or have ever taken medicine for mental health.
  • Currently use tobacco, or have ever had electroconvulsive therapy (treatment using electrical pulses to the brain).
  • Have depression symptoms above the study’s cutoff on a rating scale.
  • Have a condition affecting learning or development, such as autism or a reading disorder, that would make study tasks hard to complete.
  • For the high-risk group: have ever had major or long-lasting depression, schizophrenia or another disorder affecting sense of reality, bipolar disorder, a drug or alcohol use disorder, an eating disorder, or post-traumatic stress disorder.
  • For the low-risk group: have ever had any mental health or drug or alcohol use disorder, or have a parent, sibling, or child with a history of any mental health disorder.

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

Official eligibility criteria

Inclusion Criteria: General Inclusion Criteria for all Adolescent Cohorts: * Female sex assigned at birth * Ages 13-15 * English as first language or English Fluency * Right-handed * Have a personal cell phone to complete the ecological momentary assessments * Ability to give signed, informed consent/assent either written or electronic (via RedCap eConsent) * Normal or corrected to normal vision and hearing Additional Inclusion Criteria for Female Adolescents with a Parental History of MDD, high-risk group: • A biological parent meeting DSM-5 criteria for at least one past/current major depressive episode Exclusion Criteria: General Exclusion Criteria for all Adolescent Cohorts: • Presence of any contraindication for MRI: * Cardiac pacemakers * Metal clips on blood vessels (also called stents) * Artificial heart valve, artificial arms, hands, legs, etc. * Brain stimulator devices * Implanted drug pumps * Ear or eye implants * Known metal fragments in eyes * Exposure to metal filings or shrapnel (sheet metal workers, welders, and others) * Other metallic surgical hardware in vital area * Certain tattoos with metallic ink * Certain intrauterine devices (IUDs) containing metal * Any other metallic objects that are deemed a contraindication to MRI that cannot be removed * Certain transdermal (skin) patches such as: NicoDerm (nicotine for tobacco dependence) Transderm Scop (scopolamine for motion sickness) Ortho Evra (birth control) * Presence of medical or neurological illness that could impact fMRI measures of cerebral blood flow (e.g., head injury resulting in loss of consciousness greater than 5 minutes, seizure, tic disorder, serious/unstable cardiac, hepatic, renal, respiratory, endocrine, neurologic or hematologic illnesses) * Clinical/Laboratory Evidence of Hypothyroidism or Hyperthyroidism * Use of hormonal replacement therapy, anabolic steroids * Lifetime history of electroconvulsive therapy * Current tobacco product use * Lifetime use of any psychotropic medication * Clinically significant levels of depressive symptoms according to the Children's Depression Rating Scale-Revised (T Score \> 54, Poznanski et al., 1996) * Diagnosis of a neurodevelopmental disorder (e.g., Autism Spectrum Disorder, Learning Disorder w/ impairment in reading) that would interfere with study tasks (e.g., understanding and completing lengthy battery of questionnaires, ability to complete fMRI scan session and tasks without moving) Additional Exclusion Criteria for Female Adolescents with a Parental History of MDD, high-risk group: • Lifetime or current Diagnostic and Statistical Manual (DSM)-5 diagnoses of MDD, persistent depressive disorder, schizophrenia spectrum or other psychotic disorder, bipolar disorder, substance/alcohol use disorder, eating disorders, and posttraumatic stress disorder Additional Exclusion Criteria for Female Adolescents without a Parental History of MDD, low-risk group: * Any past or current Diagnostic and Statistical Manual (DSM)-5 psychiatric or substance/alcohol use disorder * First-degree relative history of any psychiatric disorder

Study sites (1)

MA