Adolescent Mood During Puberty and Testosterone
Part of paid clinical trials in Chapel Hill, North Carolina.
- Sponsor
- University of North Carolina, Chapel Hill
- Study ID
- NCT06072677
- Status
- Recruiting
Conditions
- Adolescent Depression
Eligibility Criteria
- Sex
- ALL
- Age
- 11 Years - 14 Years
- Healthy Volunteers
- Accepted
Interventions
- Healthy Minds Program — BEHAVIORALThe 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 podcast lessons (5-7 minutes) with psychoeducation and practical examples, and 3 guided meditations relevant to the module topic, for a total of 10 lessons and 14 guided meditations.
Study Details
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.
Key Dates
- Start date
- Aug 24, 2023
- Status verified
- Jan 2026
- Primary completion
- Dec 31, 2027
- Completion
- Dec 31, 2027
Study Design
- Enrollment
- 60 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- OTHER
Arms
- Experimental: Healthy Minds ProgramParticipants in this group will begin the Healthy Minds Program immediately following the 4-week baseline period.
- Other: Waitlist ControlAfter the 4-week baseline period, participants in the waitlist control condition will wait an additional 4 weeks before starting the Healthy Minds Program.
Primary Outcome Measure
CES-DC Score Over Time [ Time Frame: up to Week 8 ]
Central Contacts
- Kayla Jensen, BS919-445-6815
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Carolina Crossing B, Suite 1 | Chapel Hill | North Carolina | 27517 | Elizabeth Andersen, PhD (PRINCIPAL_INVESTIGATOR) |