Adolescent Mood During Puberty and Testosterone

Not Applicable

Recruiting

• Conditions: Adolescent Depression
• Interventions: Behavioral: Healthy Minds Program

• Registration Number: NCT06072677
• Lead Sponsor: University of North Carolina, Chapel Hill

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-24
• Study First Submitted: 2023-10-02
• Study First Submitted QC: 2023-10-02
• Study First Posted: 2023-10-10
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-16
• Last Update Posted: 2024-10-18
• Primary Completion: 2027-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy Minds Program	Healthy Minds Program	Participants in this group will begin the Healthy Minds Program immediately following the 4-week baseline period.
Waitlist Control	Healthy Minds Program	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 Measures

Name	Time	Method
CES-DC Score Over Time	up to Week 8	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.

Trial Locations

Locations (1)

Carolina Crossing B, Suite 1; 🇺🇸 Chapel Hill, North Carolina, United States