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 — BEHAVIORAL
    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 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 Program
    Participants in this group will begin the Healthy Minds Program immediately following the 4-week baseline period.
  • Other: Waitlist Control
    After 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

Locations (1)

FacilityCityStateZIPSite coordinators
Carolina Crossing B, Suite 1Chapel HillNorth Carolina27517
Kayla Jensen, BS
919-445-6815
Elizabeth Andersen, PhD (PRINCIPAL_INVESTIGATOR)

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