Clinical Outcomes of Cognitive Behavioral Therapy for Nightmares in Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Change on the Child Adolescent Trauma Screen (CATS) - Child Version
研究概览
简要总结
Up to 50% of children experience nightmares annually. Nightmares interfere with sleep quality and quantity resulting in sleep deficiency, and are associated with negative mental health consequences. Previous research has shown efficacy of manualized CBT treatment for reducing trauma related nightmares in adults, and preliminary evidence has shown efficacy in children. This study is the first randomized clinical trial to evaluate the effectiveness of the treatment for idiopathic, as well as trauma related nightmares in children. The treatment in a manualized CBT protocol (5 sessions) that teaches sleep hygiene, relaxation strategies, and addresses nightmares therapeutically through exposure and rescripting.
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)
盲法说明
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 must have a history of nightmares occurring approximately once or more per week over a minimum of one month.
- •Children must have verbal comprehension of at least age 5 (determined by PPVT), and be fluent in English.
- •If taking psychotropic medications, must be stable for one month.
- •Children must have a parent or legal guardian who is able to participate in treatment assignments and be able to read and speak English.
排除标准
- •Under age 5 or over age
- •No nightmares (or less than averaging one per week)
- •Apparent psychosis
- •Pervasive developmental disorder or mental retardation
- •Not able to read and speak English.
- •Sleep apnea
研究组 & 干预措施
Treatment Right-Away
Cognitive Behavioral Therapy using exposure, relaxztion, and rescripting - Child utilizes behavioral and cognitive therapy techniques of exposure therapy and cognitive restructuring.
干预措施: Cognitive Behavioral Therapy (Behavioral)
Waitlist Control
Waitlist control group will complete pre and post assessments at beginning and end of wait period.
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, an average of 6 months.
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 Trauma Related Nightmare Survey (TRNS-C) - Child Version
时间窗: Participants will be assessed at Baseline (Week 0) through study completion, an average of 6 months.
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.
Change on the Nightmare Distress Questionnaire (NDQ)
时间窗: Participants will be assessed at Baseline (Week 0) through study completion, an average of 6 months.
The NDQ is a 13 item self report measure of nightmare related distress. Higher scores are significantly related to interest in therapy for nightmares.
Change on the Nightmare Locus of Control (NLOC)
时间窗: Participants will be assessed at Baseline (Week 0) through study completion, an average of 6 months.
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 the Pittsburgh Sleep Quality Index - Modified (PSQI) - Child Version
时间窗: Participants will be assessed at Baseline (Week 0) through study completion, an average of 6 months.
The PSQI-M is a 10 item (with 2 items containing 23 sub items) self report measure of sleep quality and disturbance. It queries sleep quality and disturbances over the last month.
Change on the Children's Report of Sleep Patterns (CRSP)
时间窗: Participants will be assessed at Baseline (Week 0) through study completion, an average of 6 months.
The CRSP is a 62 item self report measure of children's sleep patterns, sleep hygiene, and sleep disturbances for children eight to 12 years of age
Change on the Sleep Locus of Control (SLOC)
时间窗: Participants will be assessed at Baseline (Week 0) through study completion, an average of 6 months.
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 on the Epworth Sleepiness Scale (ESS)
时间窗: Participants will be assessed at Baseline (Week 0) through study completion, an average of 6 months.
The ESS is an 8 item self report. The test is a list of eight situations in which one rates his/her tendency to become sleepy on a scale of 0, no chance of dozing, to 3, high chance of dozing. When the test is finished, response values are added up. The total score is based on a scale of 0 to 24. The scale estimates whether one is experiencing excessive sleepiness that possibly requires medical attention.
Change in reports on Sleep Journal
时间窗: Participants complete this assessment at Pre-treatment (for 1 week), daily during the treatment phase, at Post treatment (for 1 week), at 3 month follow-up (for 1 week), and at 6 month follow-up (for 1 week).
6 question self report that patient assesses daily from home.
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, an average of 6 months.
The CATS screens for child trauma history and PTSD symptoms (information obtained from the caregiver, about the child).
Change on the Children's Sleep Habits - Caregiver Report regarding child
时间窗: Participants will be assessed at Baseline (Week 0) through study completion, an average of 6 months.
To examine sleep habits and possible difficulties with sleep in preschool and school-aged children
Adverse Childhood Experiences for CHILD - Caregiver Report regarding child
时间窗: approximately 3 years.
Assesses adverse experiences from infancy through early childhood
Change on the Sleep Disturbances Scale for Children - Caregiver Report regarding child
时间窗: Participants will be assessed at Baseline (Week 0) through study completion, an average of 6 months.
SDSC is a 26-item inventory rated on a 5 point Likert-type scale. The instrument's purpose is to categorize sleep disorders in children
次要结局
- Change on the Parental Stress Scale(Participants will be assessed at Baseline (Week 0) through study completion, an average of 6 months.)
- Adverse Childhood Experiences for SELF - Caregiver Report regarding self(approximately 3 years.)