Probing the Neurophysiological Mechanisms Underlying Sex-specific Testosterone-mood Relationships During Puberty: A Randomized Controlled Trial Using a Smartphone-based Training Program
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- CES-DC Score Over Time
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 11 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
Healthy Minds Program
Participants in this group will begin the Healthy Minds Program immediately following the 4-week baseline period.
干预措施: Healthy Minds Program (Behavioral)
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.
干预措施: Healthy Minds Program (Behavioral)
结局指标
主要结局
CES-DC Score Over Time
时间窗: 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.
次要结局
未报告次要终点