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Adolescent Mood During Puberty and Testosterone (AMPT)

Primary Purpose

Adolescent Depression

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Healthy Minds Program
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Adolescent Depression focused on measuring Puberty, Depression, Mood disturbance, Adolescence, Stress, Peripubertal Transition, Hormones, EEG, Sex differences

Eligibility Criteria

11 Years - 14 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Carolina Crossing B, Suite 1Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Healthy Minds Program

Waitlist Control

Arm Description

Participants in this group will begin the Healthy Minds Program immediately following the 4-week baseline period.

After the 4-week baseline period, participants in the waitlist control condition will wait an additional 4 weeks before starting the Healthy Minds Program.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
October 2, 2023
Last Updated
October 2, 2023
Sponsor
University of North Carolina, Chapel Hill
Collaborators
Foundation of Hope, North Carolina
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1. Study Identification

Unique Protocol Identification Number
NCT06072677
Brief Title
Adolescent Mood During Puberty and Testosterone
Acronym
AMPT
Official Title
Probing the Neurophysiological Mechanisms Underlying Sex-specific Testosterone-mood Relationships During Puberty: A Randomized Controlled Trial Using a Smartphone-based Training Program
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 24, 2023 (Actual)
Primary Completion Date
December 2027 (Anticipated)
Study Completion Date
December 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
Foundation of Hope, North Carolina

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adolescent Depression
Keywords
Puberty, Depression, Mood disturbance, Adolescence, Stress, Peripubertal Transition, Hormones, EEG, Sex differences

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Healthy Minds Program
Arm Type
Experimental
Arm Description
Participants in this group will begin the Healthy Minds Program immediately following the 4-week baseline period.
Arm Title
Waitlist Control
Arm Type
Other
Arm Description
After the 4-week baseline period, participants in the waitlist control condition will wait an additional 4 weeks before starting the Healthy Minds Program.
Intervention Type
Behavioral
Intervention Name(s)
Healthy Minds Program
Intervention Description
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 Outcome Measure Information:
Title
CES-DC Score Over Time
Description
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.
Time Frame
up to Week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kayla Jensen, BS
Phone
919-445-6815
Email
nerdlab@unc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth Andersen, PhD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
Carolina Crossing B, Suite 1
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27517
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kayla Jensen, BS
Phone
919-445-6815
Email
nerdlab@unc.edu
First Name & Middle Initial & Last Name & Degree
Elizabeth Andersen, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

Adolescent Mood During Puberty and Testosterone

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