NCT01776229已完成不适用
Exposure, Relaxation, & Rescripting Therapy-Child
University of Tulsa2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2012年10月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Trauma Related Nightmare Survey - Child Version (TRNS-C) Reflecting change in nightmare frequency, severity, and duration.
研究概览
简要总结
Untreated trauma-related nightmares and sleep-related disorders are associated with chronic health problems, burdening both the suffering individual and the health-care system. The study implements an innovative, cost-efficient, nightmare treatment for trauma-exposed children. It is the first randomized clinical trial with children, adapting an efficacious adult therapy to a 5-session nightmare treatment for 5-17 year-olds. Trauma nightmares are a mechanism in development and maintenance of secondary post-trauma psychopathology, medical problems and family dysfunction. Therefore, this treatment may prevent long-term secondary health and behavioral problems. It provides a viable healthcare option to Oklahomans, lessening long-term financial medical and behavioral health expenses. Scientific models currently view PTSD treatment as primary, often leaving nightmares untreated. That approach does not address the pernicious impact of trauma-nightmares in individuals with sub-threshold PTSD or whose nightmares are a primary condition. The theoretical innovation of this therapy can advance the field's understanding of the development of trauma sequelae.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children age 5-17 with traumatic or potentially traumatic/adverse experiences and nightmares occurring at least once per week over a minimum of one month
- •have a parent or legal guardian who is able to participate in treatment assignments at home and be able to read and speak English
排除标准
- •adult, no traumatic experience, no nightmares, apparent psychosis, pervasive developmental disorder, or mental retardation, not able to read and speak English
- •in order to ensure the verbal comprehension of the child, the PPVT will be used to help evaluate if a child is suitable for treatment, as an index to ensure they can verbally comprehend the cognitive component of treatment
结局指标
主要结局
Trauma Related Nightmare Survey - Child Version (TRNS-C) Reflecting change in nightmare frequency, severity, and duration.
时间窗: Participants will be assessed immediately after treatment which occurs on average for 5 weeks, and then will be assessed for followups at 3 months and 6 months post treatment.
The TRNS-C is a 14-item self-report measure that assesses current sleep quality, frequency, severity, and duration of nightmares, as well as cognitions, emotions, and behaviors related to nightmares in children.
次要结局
- Strengths and Difficulties Questionnaire - Parent Version (SDQ)(Participants will be assessed immediately after treatment which occurs on average for 5 weeks, and then will be assessed for followups at 3 months and 6 months post treatment.)
- Pittsburgh Sleep Quality Index - Parent self-report (PSQI)(Participants will be assessed immediately after treatment which occurs on average for 5 weeks, and then will be assessed for followups at 3 months and 6 months post treatment.)
- Strengths and Difficulties Questionnaire - Child Version (SDQ)(Participants will be assessed immediately after treatment which occurs on average for 5 weeks, and then will be assessed for followups at 3 months and 6 months post treatment.)
- Child Behavior Checklist - Teacher Form (CBCL-TR)(Participants will be assessed immediately after treatment which occurs on average for 5 weeks.)
- Animal Sorting(Participants will be assessed immediately after treatment which occurs on average for 5 weeks, and then will be assessed for followups at 3 months and 6 months post treatment.)
- Nightmare Distress Questionnaire - Modified (NDQ)(Participants will be assessed immediately after treatment which occurs on average for 5 weeks, and then will be assessed for followups at 3 months and 6 months post treatment.)
- Revised Child Anxiety and Depression Scale (RCADS)(Participants will be assessed immediately after treatment which occurs on average for 5 weeks, and then will be assessed for followups at 3 months and 6 months post treatment.)
- The Parenting Stress Scale (PSS)(Participants will be assessed immediately after treatment which occurs on average for 5 weeks, and then will be assessed for followups at 3 months and 6 months post treatment.)
- Behavior Rating Inventory of Executive Function - Parent Form (BRIEF)(Participants will be assessed immediately after treatment which occurs on average for 5 weeks, and then will be assessed for followups at 3 months and 6 months post treatment.)
- Child Attention Network Task (Child ANT)(Participants will be assessed immediately after treatment which occurs on average for 5 weeks, and then will be assessed for followups at 3 months and 6 months post treatment.)
- Trail Making Test(Participants will be assessed immediately after treatment which occurs on average for 5 weeks, and then will be assessed for followups at 3 months and 6 months post treatment.)
- Clocks(Participants will be assessed immediately after treatment which occurs on average for 5 weeks, and then will be assessed for followups at 3 months and 6 months post treatment.)
- R-CBM(Participants will be assessed immediately after treatment which occurs on average for 5 weeks, and then will be assessed for followups at 3 months and 6 months post treatment.)
- Pittsburgh Sleep Quality Index (PSQI)(Participants will be assessed immediately after treatment which occurs on average for 5 weeks, and then will be assessed for followups at 3 months and 6 months post treatment.)
- Child Behavior Checklist for Ages 1.5-5 (CBCL/1.5-5)(Participants will be assessed immediately after treatment which occurs on average for 5 weeks, and then will be assessed for followups at 3 months and 6 months post treatment.)
- Children's Sleep Habits Questionnaire (CSHQ)(Participants will be assessed immediately after treatment which occurs on average for 5 weeks, and then will be assessed for followups at 3 months and 6 months post treatment.)
- Actiwatch-2 Wrist Monitor(The wrist actigraph will be worn between session for a specified amount of time. The actigraph will be worn continously during the loan period except for swimming, other continous water sports, and bathing.)
- University of California at Los Angeles Post-traumatic Stress Disorder Reaction Index for the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) (UPID)(Participants will be assessed immediately after treatment which occurs on average for 5 weeks, and then will be assessed for followups at 3 months and 6 months post treatment.)
- Child Behavior Checklist for Ages 6-18 (CBCL/6-18)(Participants will be assessed immediately after treatment which occurs on average for 5 weeks, and then will be assessed for followups at 3 months and 6 months post treatment.)
- Letter-Number Sequencing(Participants will be assessed immediately after treatment which occurs on average for 5 weeks, and then will be assessed for followups at 3 months and 6 months post treatment.)
- The McMaster Family Assessment Device (FAD)(Participants will be assessed immediately after treatment which occurs on average for 5 weeks, and then will be assessed for followups at 3 months and 6 months post treatment.)
- Behavior Rating Inventory of Executive Function - Teacher Form (BRIEF)(Participants will be assessed immediately after treatment which occurs on average for 5 weeks.)
- MAZE(Participants will be assessed immediately after treatment which occurs on average for 5 weeks, and then will be assessed for followups at 3 months and 6 months post treatment.)
- Auditory Attention and Response Set(Participants will be assessed immediately after treatment which occurs on average for 5 weeks, and then will be assessed for followups at 3 months and 6 months post treatment.)
- Digit span(Participants will be assessed immediately after treatment which occurs on average for 5 weeks, and then will be assessed for followups at 3 months and 6 months post treatment.)
研究者
Lisa Cromer
Associate Professor of Psychology
University of Tulsa
研究点 (2)
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