跳至主要内容
临床试验/NCT05241314
NCT05241314已完成不适用

Intergenerational Trauma in War-affected Families: Promoting Adolescent Adjustment Through a Family Mindfulness-based Intervention

University of Minnesota2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2022年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
25
试验地点
2
主要终点
Youth Adjustment

研究概览

简要总结

This study has two central research questions: 1) Is implementing a family mindfulness-based intervention with war-affected immigrant families through community based participatory research methods feasible?; and 2) Does the intervention demonstrate preliminary improvements in the social and behavioral health of war-affected caregivers and youth by addressing patterns of behavior that potentiate intergenerational trauma? The objective in the proposed study is to use Community Based Participatory Research strategies to test the feasibility and acceptability of a mindfulness-based intervention for Karen refugee families living post-resettlement in the United States. A key focus in this phase of the pilot will be intervention adaptation and establishing fidelity monitoring and quality improvement procedures through which the PI and community health worker interventionists are trained and evaluated in the delivery of the intervention.

详细描述

Intergenerational trauma is a major public health problem impacting war-affected families. The investigators' specific research contribution will test the feasibility of a 7-week family mindfulness-based intervention addressing key mechanisms central to the health of war-affected families. The significance of this contribution is tied to the conceptual understanding that caregivers uniquely influence the ways in which their children process trauma, experience stressful events, and thrive socially, behaviorally and physically. The responses of youth, in turn, affect the well-being of their parents. Left unaddressed, intergenerational trauma will continue to negatively impact the health and life course of immigrant youth and families. Collectively, this contributes to: higher burden of unaddressed mental and physical health disturbances in caregivers and youth; disruptions in family systems and community structures that negatively impact educational achievement and other indicators of youth adjustment; and increased exposure to familial and community violence. If a mindfulness-based intervention delivered directly to war-affected families in their homes can demonstrate improvements in the behavioral and social health effects of war trauma experienced by caregivers and their youth, then this study has the potential to offer a novel, effective approach to disrupting the generational impacts of war on war-affected families. The study will engage mothers, fathers, and youth to address intergenerational trauma fully. The investigators will establish plans for collaborative dissemination with WellShare International in phase I of the Clinical Translational Research Service pilot award, including academic dissemination (presentation and publication) as well as dissemination of results among key stakeholders and community members.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
11 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult inclusion criteria:
  • Above the age of 18
  • Karen refugees resettled to the United States greater than one year prior to enrollment
  • Caregiving responsibility for at least one child between the ages of 11 and 18
  • Reported primary or secondary torture or war trauma exposure, based on assessments conducted during UMN IRB STUDY00000729
  • Participation in UMN IRB STUDY00000729 and having agreed to be contacted for future research
  • Youth inclusion criteria:
  • Ages 11 to 18
  • Living in the home with the primary caregivers
  • Considered a dependent of the primary caregivers (still in high school or transitioning from school to workforce, not married and/or raising their own children - will take individual youth circumstances into consideration individually to make a determination of dependence)

排除标准

  • Self-reported or study team observed severe or unstable mental or physical illness such as acute psychosis, presence or risk of safety concerns, and/or a physical disability or illness, which prevents the potential participant from engaging in the study activities. Youth will be excluded if screening is positive for PTSD. Caregivers will not be excluded if mental health screening is positive for PTSD/severe depression.
  • Nonbiological caregiving relationships with child
  • If one member of the family declines to participate in the initial enrollment, the family will be excluded. If the randomly selected index youth declines to participate, we will open enrollment to other youth in the family that meet the inclusion criteria.

结局指标

主要结局

Youth Adjustment

时间窗: 3 months

Strengths and Difficulties Questionnaire (SDQ I/S). A 25-item youth behavioral screening questionnaire, Total difficulties score: generated by summing scores from all the scales except prosocial scale, Range 0-40. Higher score, higher adjustment challenges

Mindfulness

时间窗: 3 months

Cognitive and Affective Mindfulness Scale-Revised (CAMS-R). A 12-item assessment of mindfulness as a single construct. Items 2, 6, and 7 reverse-scored. After reversals, sum values for items 1-12. Sum of all values reflect greater mindful qualities. The range of the Cognitive and Affective Mindfulness Scale-Revised (CAMS-R) is 12-48. It is a 12-item scale where each item is rated on a 1-4 Likert scale, with higher scores indicating greater mindfulness.

Youth Trauma History, PTSD Screening

时间窗: 3 months

UCLA Brief Screen for Child/Adolescent Trauma and PTSD (UCLA-B). A 11-item (+2 open ended) evaluation of trauma history and PTSD symptoms for identifying at-risk cases. A cutoff score of 35 is highly sensitive and specific for detecting a diagnosis of PTSD. Higher score, higher burden of PTSD symptoms UCLA brief trauma screen: This was a screening tool used to establish the eligibility of youth participants. This was not included in the analysis. Each item on the scale is rated on a 0-4 scale, with higher scores signifying greater symptom severity, range 0-44. The FACES instrument is not scored based on a range, as described.

Emotion Regulation

时间窗: 3 months

Emotion Regulation Skills Questionnaire (ERSQ). A 27-item assessment of emotion regulation skills described in the ART model. Calculated mean of all questions. Higher score indicates better Emotion Regulation. The Emotion Regulation Skills Questionnaire (ERSQ) is a 27 item scale that uses a 5-point Likert scale for each item, 0 (not at all) to 4 (almost always), with a total score range of 0-108.

Parent Mental Health Distress

时间窗: 3 months

Karen Mental Health Screener - Brief (KMHS-B). 5-item measure developed to screen for mental distress associated with MDD and PTSD. Possible score ranges for five items 0-15. For clinical use, clinical cut score of 4. Higher score, higher burden of PTSD symptoms. Used cut score to refer

次要结局

  • Physical Health Status(3 months)
  • Family Functioning(3 months)
  • Emotion Regulation(3 months)
  • Physical Symptom Burden(3 months)
  • Mindfulness(3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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