Evaluating the Feasibility of a Cognitive-Behavioral Therapy for Children With Nightmares as a Mediator of Suicide Risk
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 4
- 主要终点
- Change on the Child Adolescent Trauma Screen (CATS) - Child Version
研究概览
简要总结
Youth suicide risk has increased 56% in the last decade, and suicide is the leading cause of preventable death in children and adolescents. Experiencing chronic nightmares doubles the risk of suicidal ideation in children and adolescents. Decades of research support that even when controlling for depression and insomnia, nightmares predict suicidality. Contemporary theories model nightmares as the mediating link between depression and suicide. Numerous studies examine the effect of nightmare-specific therapies on reducing suicide in adults, but none have examined whether nightmare therapies can reduce youth suicidality. The proposed pilot will evaluate the feasibility of the Cognitive Behavioral Therapy for Nightmares in Children paradigm (CBT-NC), recruiting and retaining children ages 6-17 who experience chronic nightmares. Utilizing a waitlist control (WL) model, participants (n=30) will be randomized after baseline assessment to either immediate treatment or a WL. Feasibility will be evaluated by examining retention through treatment (or WL) to post WL and post treatment assessments. Both groups will be evaluated before and after the treatment for suicidal ideation, sleep quality, and nightmare distress and frequency, in order to document improvements due to therapy. The proposed pilot will provide preliminary data about recruitment, retention, and allow for effect size calculations between groups. These results will be used to develop a larger treatment study that would ultimately evaluate the mediating effect of treatment for chronic nightmares on suicidality in children.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Child must be between the ages of 6-17 years 11 months.
- •Child must report recurrent nightmares that meet DSM criteria for nightmare disorder.
- •Child must speak and understand English at no less than a 6 year old level.
- •Children on prescribed psychotropic medications must be stable for 30 days prior to enrolling.
- •Child must have a parent or legal guardian attend study visits with them.
- •Participants must have access to WIFI/phone data in order to participate in this study, and must have an electronic device with a camera enabled. Our study team will have the capability of driving a tablet to the participant's home if that is the only reason they cannot participate, and if the family lives within the greater Tulsa area.
排除标准
- •Children with a previous diagnosis of sleep apnea which is not adequately treated.
- •Children whose receptive/expressive language skills are below a 6 year old level.
- •If it is determined that a child is actively suicidal and at imminent risk for self-harm, the family will be notified and referred for immediate care. They will not be eligible for the study until they are deemed stable.
结局指标
主要结局
Change on the Child Adolescent Trauma Screen (CATS) - Child Version
时间窗: Participants will be assessed at Baseline (Week 0) through study completion, up to 15 weeks.
The CATS screens for child trauma history and PTSD symptoms in youth ages 7-17; 15 YES/NO questions; 1 open-ended question
Change on the Child Adolescent Trauma Screen (CATS) - Caregiver Report regarding child
时间窗: Participants will be assessed at Baseline (Week 0) through study completion, up to 15 weeks.
The CATS screens for child trauma history and PTSD symptoms (information obtained from the caregiver, about the child).
Change on the Trauma Related Nightmare Survey - Child Version (TRNS-C)
时间窗: Participants will be assessed at Baseline (Week 0) through study completion, up to 15 weeks.
The TRNS-C is a 14 item self report questionnaire that assesses current sleep quality, frequency, severity, and duration of nightmares, as well as cognitions, emotions, and behaviors related to nightmares in children.
Change on Sleep Locus of Control (SLOC)
时间窗: Participants will be assessed at Baseline (Week 0) through study completion, up to 15 weeks.
The SLOC is an 6 item self report measure perceived contingencies between sleep behavior and events. This scale is collected as a child self report, and a caregiver report regarding child.
Change in reports on Sleep Journal
时间窗: Participants complete this assessment at Pre-treatment (for 1 week), daily during the treatment phase (an average of 5 weeks), at Post treatment (for 1 week).
6 question self report that patient assesses daily from home.
Change on Nightmare Locus of Control (NLOC)
时间窗: Participants will be assessed at Baseline (Week 0) through study completion, up to 15 weeks.
The N-LOC is an 6 item self report. This scale is collected as a child self report, and a caregiver report regarding child.
Change on Center for Epidemiologic Studies Beliefs and Attitudes About Sleep Scale (DBAS-16)
时间窗: Participants will be assessed at Baseline (Week 0) through study completion, up to 15 weeks.
The DBAS-16 is a 16-item self-report measure that evaluates the role of sleep related beliefs. The score is a sum of the 16 items, ranging from 16 to 80. Higher scores represent more dysfunctional beliefs about sleep.
Change on Center for Epidemiologic Studies Depression Scale for Children (CES-DC)
时间窗: Participants will be assessed at Baseline (Week 0) and after post-condition (Week 6).
The CES-DC is a 20-item self-report depression inventory. A score of 15 or higher indicates significant levels of depression.
次要结局
未报告次要终点