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NCT Number: NCT06072677

Adolescent Mood During Puberty and Testosterone

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.

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Key information

Conditions

Adolescent Depression Behavior Behavioral Symptoms Depression

Age range

11 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Carolina Crossing B, Suite 1

Chapel Hill, North Carolina, 27517, United States

Location status: Recruiting

Location contact

Elizabeth Andersen, PhD

PRINCIPAL_INVESTIGATOR

Kayla Jensen, BS

CONTACT

[email protected]

919-445-6815

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. CES-DC Score Over Time

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Kayla Jensen, BS

CONTACT

[email protected]

919-445-6815

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • Foundation of Hope, North Carolina

Registry information

Official study title

Probing the Neurophysiological Mechanisms Underlying Sex-specific Testosterone-mood Relationships During Puberty: A Randomized Controlled Trial Using a Smartphone-based Training Program

Acronym: AMPT

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Oct 10, 2023
Registry last updated
Jan 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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