NCT02873078已完成不适用
Internet-Delivered Cognitive Behavior Therapy for Children With Functional Abdominal Pain Disorders - a Randomized Controlled Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 91
- 试验地点
- 2
- 主要终点
- PedsQL Gastro
研究概览
简要总结
This randomized controlled study aims to evaluate the efficacy of exposure-based Internet-delivered cognitive behavior therapy for children 8-12 years with Functional Abdominal Pain Disorders. The children participate along with their parents, who will also receive specific modules with information on how to support their children in the treatment. Predictors and mediators for treatment effects will be studied as well as the cost effectiveness of the intervention.
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
- None
入排标准
- 年龄范围
- 8 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children 8-12 years with either irritable bowel syndrome, functional dyspepsia or functional abdominal pain - not otherwise specified diagnosed according to Rome-III or Rome-IV criteria.
- •Psychopharmacological medication stable for at least a month if medicating.
- •Child and at least one parent speaking and writing swedish.
- •Access to computer with Internet connection.
排除标准
- •Severe somatic disorder and/or if the child fulfills criteria of other disorder that better explains the abdominal symptoms.
- •Severe psychiatric or social problems that needs other care.
- •Ongoing psychological treatment.
- •School absenteeism more than 40 %.
结局指标
主要结局
PedsQL Gastro
时间窗: Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
Change in gastrointestinal symptoms measured with a self-rating scale from baseline to 10 weeks, from baseline to 9 months, and from baseline to 15 months for analysis of effect.
次要结局
- Faces Pain Rating Scale(Weekly during treatment (treatment week 1-9).)
- Faces Pain Rating Scale rated by parents(Weekly during treatment (treatment week 1-9).)
- PedsQL Gastro rated by parents(Weekly during treatment (treatment week 1-9).)
- Pediatric quality of life inventory (PedsQL QOL)(Baseline to 10 weeks, baseline to 9 months, baseline to 15 months)
- Pediatric quality of life inventory (PedsQL QOL) rated by parents(Baseline to 10 weeks, baseline to 9 months, baseline to 15 months)
- Painfree days(Weekly during treatment (treatment week 1-9))
- Painfree days rated by parents(Weekly during treatment (treatment week 1-9))
- IBS-Behavioral responses questionnaire (IBS-BRQ)(Weekly during treatment (treatment week 1-9))
- Spence Children Anxiety Scale - short version (SCAS-S) rated by parents(Baseline to 10 weeks, baseline to 9 months, baseline to 15 months)
- Visceral Sensitivity Index(Weekly during treatment (treatment week 1-9))
- IBS-Behavioral responses questionnaire (IBS-BRQ) parental version(Weekly during treatment (treatment week 1-9))
- Spence Children Anxiety Scale - short version (SCAS-S)(Baseline to 10 weeks, baseline to 9 months, baseline to 15 months)
- Adverse events (AE)(At week 10)
- Child Depression Inventory - short version (CDI-S)(Baseline to 10 weeks, baseline to 9 months, baseline to 15 months)
- Client Satisfactory Questionnaire (CSQ)(At week 10)
- Rome-IV questionnaire(Baseline to 10 weeks, baseline to 9 months, baseline to 15 months)
- Client Satisfactory Questionnaire (CSQ) rated by parents(At week 10)
- Subjective Assessment Questionnaire (SAQ)(At week 10)
- Subjective Assessment Questionnaire (SAQ) rated by parents(At week 10)
- Kidscreen(Baseline to 10 weeks, baseline to 9 months, baseline to 15 months)
- School absenteeism rated by parents(Weekly during treatment (treatment week 1-9))
- Working Alliance Inventory (WAI) short version(At week 4)
- The treatment credibility scale rated by parents.(At week 2)
- Trimbos and Institute of Technology Cost Questionnaire for Psychiatry (TIC-P) rated by parents(Baseline, at weeks 3, 7, 10 and at 9 months)
- General health questionnaire (GHQ-12) rated by parents(Baseline to 10 weeks, baseline to 9 months, baseline to 15 months)
- Generalised anxiety disorder assessment (GAD 7) rated by parents(Baseline to 10 weeks, baseline to 9 months, baseline to 15 months)
- Pain Catastrophizing Scale, parental version (PCS-P)(Weekly during treatment (treatment week 1-9))
- Children´s Somatization Inventory (CSI 24) rated by parents(Baseline to 10 weeks, baseline to 9 months, baseline to 15 months)
- Adult responses to children's symptoms (ARCS) rated by parents(Weekly during treatment (treatment week 1-9))
- PedsQL Gastro(Weekly during treatment (treatment week 1-9).)
研究者
研究点 (2)
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