- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06072677
Adolescent Mood During Puberty and Testosterone (AMPT)
October 2, 2023 updated by: University of North Carolina, Chapel Hill
Probing the Neurophysiological Mechanisms Underlying Sex-specific Testosterone-mood Relationships During Puberty: A Randomized Controlled Trial Using a Smartphone-based Training Program
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Kayla Jensen, BS
- Phone Number: 919-445-6815
- Email: nerdlab@unc.edu
Study Locations
-
-
North Carolina
-
Chapel Hill, North Carolina, United States, 27517
- Recruiting
- Carolina Crossing B, Suite 1
-
Principal Investigator:
- Elizabeth Andersen, PhD
-
Contact:
- Kayla Jensen, BS
- Phone Number: 919-445-6815
- Email: nerdlab@unc.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Healthy Minds Program
Participants in this group will begin the Healthy Minds Program immediately following the 4-week baseline period.
|
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.
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
up to Week 8
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Elizabeth Andersen, PhD, University of North Carolina, Chapel Hill
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 24, 2023
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
December 1, 2027
Study Registration Dates
First Submitted
October 2, 2023
First Submitted That Met QC Criteria
October 2, 2023
First Posted (Estimated)
October 9, 2023
Study Record Updates
Last Update Posted (Estimated)
October 9, 2023
Last Update Submitted That Met QC Criteria
October 2, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 23-1336
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
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.
IPD Sharing Time Frame
beginning 9 and continuing for 36 months following publication
IPD Sharing Access Criteria
Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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