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临床试验/NCT02588079
NCT02588079已完成不适用

Internet-Based Cognitive Behavioral Therapy for Children With Dental Anxiety- A Randomized Controlled Trial

Karolinska Institutet2 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2015年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
33
试验地点
2
主要终点
Picture guided behavioral approach test, parent version

研究概览

简要总结

The purpose of this study is to determine whether internet-based cognitive behavioral therapy (ICBT) is effective in the treatment of children and adolescents with dental anxiety. The investigators hypothesis is that children and adolescents who have been offered ICBT show significant better performance on outcome measures compared with patients in control group.

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 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • The participant is between 8-15 years of age
  • The patient and parents agree to participate in the research project
  • A diagnosis of specific phobia (dental anxiety or intraoral needle phobia) can be established by a psychologist according to the Diagnostic and Statistical Manual of Mental Disorders, 4th. Edition. The internet parent version of Development and Well-Being Assessment (Dawba) and Kiddie Sads (phobic disorders supplement) are used.
  • The patient and parents have sufficient language skills in Swedish to manage the treatment and questionnaires
  • Have regularly access to computer and the internet
  • Have the time, the possibility and motivation to work and practice with ICBT 3 hours each week in 12 weeks
  • Parents agree to at least book three visits at the dentist during the 12 weeks treatment
  • Parents agree to exposure for intraoral injection at the dentist even if the child does not need dental treatment but suffers from injection phobia

排除标准

  • Full points on both child and parent versions of the picture guided behavioral approach test. A maximum score of 17 means that both the child and the parent assess that the child can manage the most challenging situations in dentistry
  • A score of 31 or less on both children and parent version of CFSS-DS and do not fulfill criteria for intra-oral injection phobia
  • Already have or according to DAWBA and/or telephone interview by psychologist likely to fulfill criteria for a neurodevelopmental disorder diagnosis
  • Other psychiatric disorders such as severe depression, eating disorder or self harm behavior that need treatment prior to dentistry related specific phobia
  • The participant is undergoing or has planned psychiatric/ psychological examination
  • The participant has current/planed psychological treatments
  • Stressful life experiences during the past 12 months, such as divorce in the family, somatic illness that parent or the psychologist see as an obstacle in the treatment
  • Have received cognitive behavioral treatment for dental anxiety or needle phobia during the past three years

结局指标

主要结局

Picture guided behavioral approach test, parent version

时间窗: post treatment(12 weeks), and follow up (12 months after posttreatment)

Measures changes in the child´s ability to manage dental situations according to a parent. The test shows 17 realistic images from the dental care.

Picture guided behavioral approach test, child version

时间窗: post treatment(12 weeks), and follow up (12 months after posttreatment)

Measures changes in self-estimated ability to manage 17 dental situations, showing realistic images from dental care.

次要结局

  • Self-Efficacy Questionnaire for Phobic Situations ( dentistry adapted version )(post treatment(12 weeks), and follow up (12 months after posttreatment))
  • Children's Fear Survey Schedule - Dental Subscale (child version)(post treatment(12 weeks), and follow up (12 months after posttreatment))
  • Kiddie Sads (phobic disorders supplement)(post treatment(12 weeks), and follow up (12 months after posttreatment))
  • Children's Fear Survey Schedule - Dental Subscale (parent version)(post treatment(12 weeks), and follow up (12 months after posttreatment))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Shervin Shahnavaz

Psychologist

Karolinska Institutet

研究点 (2)

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