跳至主要内容
临床试验/NCT03869749
NCT03869749终止不适用

Decreasing Stress and Anxiety in Adolescents From High-Conflict Homes: Testing a Mindfulness Group + Ecological Momentary Intervention

Colorado State University2 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2021年2月17日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
5
试验地点
2
主要终点
Safe implementation

研究概览

简要总结

This study will evaluate the feasibility and acceptability of Learning to BREATHE (a mindfulness intervention for adolescents) plus an ecological momentary intervention (Learning to Breathe Plus), and will examine the extent to which mindfulness reduces dysregulated stress physiology, perceived stress, and anxiety in adolescents from high conflict homes.

详细描述

Adolescents from homes with interparental conflict will be randomly assigned to Learning to BREATHE Plus (the standard group program designed to increase mindfulness, plus a multi-method adaptive intervention that will be comprised of an ecological momentary intervention and online library of mindfulness practices) or to a health and wellness active control condition to determine feasibility, acceptability, and potential effectiveness of Learning to BREATHE Plus.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

盲法说明

The majority of study personnel, including the PI and study statistician, will be blinded until database lock. All individuals who will be involved with endpoint assessment will be blinded until database lock. Intervention facilitators will not be blinded, but will not be involved in endpoint assessment.

入排标准

年龄范围
14 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • two parents in the home
  • an adolescent who is between 14 and 18 years of age
  • marital distress and/or problematic interparental conflict (based on parent or youth reports)
  • youth reports of stress or anxiety

排除标准

  • two parents in the home, but they are pursuing legal divorce or separation
  • parents are not willing to receive marital education/support
  • adolescents are severely clinically depressed or report suicidal ideation at baseline

结局指标

主要结局

Safe implementation

时间窗: Across 8-week intervention period

Implementation without increase in symptomatology

Recruitment of target sample size

时间窗: Across 8-week intervention period

Successful recruitment of 38 families (114 individuals)

Enrollment of percent eligible

时间窗: Across 8-week intervention period

Enrolling a high percent of eligible families to the study/intervention

Retention to interventions

时间窗: Across 8-week intervention period

A high proportion of adolescents will attend 4/6 sessions

次要结局

  • Acceptability of interventions(Across 8-week intervention period)
  • Feasibility of implementation(Across 8-week intervention period)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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