Adolescent Mood During Puberty and Testosterone
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Healthy Minds Program.
- Who it may be relevant to
- Registry conditions: Adolescent Depression. Basic parameters: 11 years — 14 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Probing the Neurophysiological Mechanisms Underlying Sex-specific Testosterone-mood Relationships During Puberty: A Randomized Controlled Trial Using a Smartphone-based Training Program
Overview
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.
Interventions
- Behavioral Healthy Minds Program
The Healthy Minds Program is a 4-week mobile program to improve coping and emotion regulation skills. It includes 4 training modules corresponding to key pillars of wellbeing: awareness(focused attention/awareness of thoughts/emotions), connection (empathy, compassion, social connection), insight (clarity of identify/experience) and purpose (applying values/motivations). The Healthy Minds Program includes 2 introductory audio lessons and guided meditations, and each 1-week module includes 2 podc
Primary outcome measures
- CES-DC Score Over Time [Time frame: up to Week 8]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Other
Study locations
United States · 1 center
- Carolina Crossing B, Suite 1 — Chapel Hill
Identifiers
NCT: NCT06072677 · 23-1336