RECRUITING

Stress Dynamics and Familial Risk for Depression in Female Adolescents

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Tracking the Dynamic Trajectory of Behavioral, Physiological, and Neurobiological Stress Responses in Female Adolescents at High and Low Familial Risk for Depression

Quick Facts

Study Start:2025-09-23
Study Completion:2030-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06816329

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:13 Years to 15 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Female sex assigned at birth
  2. * Ages 13-15
  3. * English as first language or English Fluency
  4. * Right-handed
  5. * Have a personal cell phone to complete the ecological momentary assessments
  6. * Ability to give signed, informed consent/assent either written or electronic (via RedCap eConsent)
  7. * Normal or corrected to normal vision and hearing
  1. * Cardiac pacemakers
  2. * Metal clips on blood vessels (also called stents)
  3. * Artificial heart valve, artificial arms, hands, legs, etc.
  4. * Brain stimulator devices
  5. * Implanted drug pumps
  6. * Ear or eye implants
  7. * Known metal fragments in eyes
  8. * Exposure to metal filings or shrapnel (sheet metal workers, welders, and others)
  9. * Other metallic surgical hardware in vital area
  10. * Certain tattoos with metallic ink
  11. * Certain intrauterine devices (IUDs) containing metal
  12. * Any other metallic objects that are deemed a contraindication to MRI that cannot be removed
  13. * Certain transdermal (skin) patches such as:
  14. * 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)
  15. * Clinical/Laboratory Evidence of Hypothyroidism or Hyperthyroidism
  16. * Use of hormonal replacement therapy, anabolic steroids
  17. * Lifetime history of electroconvulsive therapy
  18. * Current tobacco product use
  19. * Lifetime use of any psychotropic medication
  20. * Clinically significant levels of depressive symptoms according to the Children's Depression Rating Scale-Revised (T Score \> 54, Poznanski et al., 1996)
  21. * 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)
  22. * Any past or current Diagnostic and Statistical Manual (DSM)-5 psychiatric or substance/alcohol use disorder
  23. * First-degree relative history of any psychiatric disorder

Contacts and Locations

Study Contact

Emily Belleau
CONTACT
617-855-4245
ebelleau@mclean.harvard.edu

Principal Investigator

Emily Belleau, Ph.D.
PRINCIPAL_INVESTIGATOR
Mclean Hospital

Study Locations (Sites)

McLean Hospital
Belmont, Massachusetts, 02478
United States

Collaborators and Investigators

Sponsor: Mclean Hospital

  • Emily Belleau, Ph.D., PRINCIPAL_INVESTIGATOR, Mclean Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-09-23
Study Completion Date2030-03-31

Study Record Updates

Study Start Date2025-09-23
Study Completion Date2030-03-31

Terms related to this study

Keywords Provided by Researchers

  • stress
  • depression
  • adolescents
  • neuroimaging
  • familial risk

Additional Relevant MeSH Terms

  • Major Depressive Disorder