Adolescent Mood During Puberty and Testosterone
AMPT
Probing the Neurophysiological Mechanisms Underlying Sex-specific Testosterone-mood Relationships During Puberty: A Randomized Controlled Trial Using a Smartphone-based Training Program
1 other identifier
interventional
60
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2023
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 24, 2023
CompletedFirst Submitted
Initial submission to the registry
October 2, 2023
CompletedFirst Posted
Study publicly available on registry
October 10, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
January 14, 2026
January 1, 2026
4.3 years
October 2, 2023
January 12, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
CES-DC Score Over Time
The 20-item Center for Epidemiological Studies Depression Scale for Children (CES-DC) will be the primary measure of severity of depressive symptoms. Each item is rated 0 (not at all) to 3 (a lot), with items 4, 8, 12, and 16 being reversed scored. The total CES-DC score may range from 0-60. Higher scores indicate more severe depressive symptoms. Scores of 15 or greater are suggestive of significant depressive symptoms. The overall CES-DC score will be assessed at the end of each week in the study.
up to Week 8
Study Arms (2)
Healthy Minds Program
EXPERIMENTALParticipants in this group will begin the Healthy Minds Program immediately following the 4-week baseline period.
Waitlist Control
OTHERAfter the 4-week baseline period, participants in the waitlist control condition will wait an additional 4 weeks before starting the Healthy Minds Program.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Carolina Crossing B, Suite 1
Chapel Hill, North Carolina, 27517, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Elizabeth Andersen, PhD
University of North Carolina, Chapel Hill
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 2, 2023
First Posted
October 10, 2023
Study Start
August 24, 2023
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
December 1, 2027
Last Updated
January 14, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- beginning 9 and continuing for 36 months following publication
- Access Criteria
- Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.
Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.