RECRUITING

Adolescent Mood During Puberty and Testosterone

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

Starting at puberty, female adolescents are nearly three-times more likely to develop internalizing disorders, like depression, while male adolescents are two-times more likely to develop externalizing disorders, like attention deficit hyperactivity disorder (ADHD). This divergence between the sexes during puberty suggests sex-specific pathways of risk and differential effects of sex hormones. The purpose of this research is to determine: 1) sex-specific neural and endocrine features of the pubertal transition that may mediate sex differences in adolescent mood disorders, and 2) the neurophysiological basis of susceptibility to hormone change during puberty.

Official Title

Probing the Neurophysiological Mechanisms Underlying Sex-specific Testosterone-mood Relationships During Puberty: A Randomized Controlled Trial Using a Smartphone-based Training Program

Quick Facts

Study Start:2023-08-24
Study Completion:2027-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06072677

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:11 Years to 14 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Between the ages of 11 and 14
  2. * Have their own personal mobile device and capability to download the MyCap and Healthy Minds apps
  3. * Experienced a stressful life event within the last year, or endorse moderate depression (defined by a CES-DC score 16 or higher)
  1. * Previous experience with the Healthy Minds Program
  2. * Regular meditation practice
  3. * Current or history of manic episodes, psychotic symptoms, or current suicidal intent
  4. * Taking any form of exogenous hormones or intrauterine device (IUD) within one month of participation in the study
  5. * Taking medications that directly alter cardiovascular or neurological function

Contacts and Locations

Study Contact

Kayla Jensen, BS
CONTACT
919-445-6815
nerdlab@unc.edu

Principal Investigator

Elizabeth Andersen, PhD
PRINCIPAL_INVESTIGATOR
University of North Carolina, Chapel Hill

Study Locations (Sites)

Carolina Crossing B, Suite 1
Chapel Hill, North Carolina, 27517
United States

Collaborators and Investigators

Sponsor: University of North Carolina, Chapel Hill

  • Elizabeth Andersen, PhD, PRINCIPAL_INVESTIGATOR, University of North Carolina, Chapel Hill

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 Date2023-08-24
Study Completion Date2027-12

Study Record Updates

Study Start Date2023-08-24
Study Completion Date2027-12

Terms related to this study

Keywords Provided by Researchers

  • Puberty
  • Depression
  • Mood disturbance
  • Adolescence
  • Stress
  • Peripubertal Transition
  • Hormones
  • EEG
  • Sex differences

Additional Relevant MeSH Terms

  • Adolescent Depression