跳至主要内容
临床试验/NCT06330779
NCT06330779招募中不适用

Trauma-adapted Yoga in Child & Adolescent Psychiatry: A Multicenter Study.

University West, Sweden1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2025年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
180
试验地点
1
主要终点
Resilience score

研究概览

简要总结

The goal of this randomized clinical trial is to evaluate the efficacy of trauma-adapted yoga as a complementary intervention to care as usual in child and adolescents psychiatry clinics, in the population of adolescents with the diagnosis of ADHD and/or PTSD. We hypothesize that trauma-adapted yoga (TAY) is an effective non-pharmacological intervention for adolescent with ADHD and/or PTSD. Aims: (1) Validate the impact of TAY on the mental health & quality of life of adolescents with ADHD and/or PTSD. (2) Investigate the feasibility of online TAY for continued self-care. (3) Explore adolescents' experiences & parental perspectives on TAY in their treatment. (4) Explore healthcare professionals' experience on the integration of TAY into clinical practice.

Within and between group (yoga group vs waiting list) analyses will be performed.

详细描述

Study Summary

Introduction:

There is growing interest in applying yoga and mindfulness techniques to children and adolescents, although research in this area remains limited. Existing studies suggest that yoga can reduce stress, improve mood, enhance resilience, and boost self-regulation skills in school settings. Additionally, these approaches hold promise for improving mental health in clinical child and adolescent populations.

Study Aim:

The aim of this study is to evaluate the impact of trauma-adapted yoga (TAY) as a complement to care as usual in Child and Adolescent Psychiatry (CAP) clinics in the USA and Sweden. The study hypothesizes that eight weeks of TAY practice will reduce negative affect states and pain intensity/frequency, while improving emotional and behavioral control, attention, and resilience. It is expected that TAY will enhance the success of other ongoing treatments in CAP, foster improved well-being, and provide patients with self-care tools.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Supportive Care
盲法
None

入排标准

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

入选标准

  • Adolescents who have received a diagnosis (not under evaluation) of PTSD and/or ADHD
  • Understanding English or Swedish languages.

排除标准

  • Ongoing substance use,
  • active manic periods,
  • psychotic disorders,
  • suicidality,
  • cognitive impairment.
  • serious physical illness prohibiting participation in physical activities.

研究组 & 干预措施

Yoga-group

Experimental

8 weeks ,once a week, instructor led trauma-adapted yoga intervention.

干预措施: Trauma-adapted yoga (Other)

Controll

No Intervention

Waiting list

结局指标

主要结局

Resilience score

时间窗: 8 weeks

social, ecological, psychological, and emotional resilience: The Child and Youth Resilience Measure-Revised-Adapted Swedish (CYRM-R-AS) is a self-report measures of social ecological and psychological, emotional resilience. In addition to an overall score of resilience, scores can be derived for the three subscales of the measures personal, caregiver and psychological/emotional resilience. The CYRM-R (simplified) is suitable for youth aged 10-23 with difficulties to comprehend text or sustain attention. Its 23 items can be scored on 3- point Likert scales. The items in the measure are all positively worded and therefore scoring involves simple summing of responses. It can be used to evaluate the efficacy of interventions to build and maintain resilience. Three sub-scales can be created . Higher scores indicate better outcome.

Negative experience score CPSS-5-S

时间窗: 8 weeks

Child PTSD Symptom Scale: 27-item self-report version rates each item from 0 (not at all) to 4 (6 or more times a week/almost always) based on the frequency and severity of the reported symptom experienced during the last month. The total severity score ranges from 0 to 80 and is calculated by summing the ratings of the first 20 items. The CPSS-5 also yields subscale scores for intrusion (Items 1-5), avoidance (Items 6-7), changes in cognition and mood (Items 8-14), and increased arousal and reactivity (Items15-20). Finally, seven items assess impairment of endorsed symptoms on daily functioning pertinent to youth (e.g., fun things you want to do, doing your chores, relationships with your friends). The respondent rates these items on a scale of 0 (not at all) to 4 (6 or more times a week/almost always), resulting in an impairment score that ranges from 0 to 28.

Inattention, impulsivity score

时间窗: 8 weeks

Parent-rated ADHD score, SNAP-IV: The SNAP-IV consists of a total of 26 questions, divided into two subscales: one for inattention symptoms and one for hyperactivity-impulsivity symptoms. Each subscale contains 9 items, and there are 8 additional questions that provide an overall assessment of impairment. Higher score indicates higher problem load.

次要结局

  • Self-directednes(8 weeks)
  • Pain frequency and intensity(8 weeks)
  • affect(8 weeks)
  • Quality of life score(8 weeks)

研究者

发起方
University West, Sweden
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验