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Adolescent Mood During Puberty and Testosterone

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
11 Years to 14 Years
Sex
All sexes
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

Not stated in the study description — ask the study team about visits and procedures.

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 brain and hormone changes during puberty may affect mood differently in girls and boys. It is for teens ages 11 to 14 who had a stressful event in the past year or have moderate signs of depression.

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.

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

Eligibility

Who can join

  • Are 11 to 14 years old.
  • Have their own mobile device and can download the MyCap and Healthy Minds apps.
  • Had a stressful life event in the past year, or score 16 or higher on the CES-DC depression survey.

Who can't join

  • Have used the Healthy Minds Program before.
  • Meditate regularly.
  • Have now or have ever had manic episodes (extreme high energy or mood) or psychotic symptoms (trouble knowing what is real), or currently intend to end their life.
  • Have used hormones from outside the body or an IUD (a birth control device placed in the womb) within one month of taking part.
  • Take medicines that directly change how the heart, blood vessels, brain, or nerves work.

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

Official eligibility criteria

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

Study sites (1)

NC