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临床试验/NCT04087616
NCT04087616Unknown不适用

Internet-based -Guided Self-help Intervention for Children With Chronic Tics Syndrome or Tourette Syndrome: Comprehensive Behavioral Intervention for Tics (CBIT) Versus Waiting List: Reduction of Tic Severity and Quality of Life Measures

Tel Aviv Medical Center2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
40
试验地点
2
主要终点
Yale Global Tic Severity Scale (YGTSS)

研究概览

简要总结

To evaluate the effect and acceptability of an Internet-based comprehensive behavioral intervention for tics (ICBIT) in a sample of children and adolescents with Tic disorders. children and adolescents (aged 8-17 years) with Tourette Syndrome (TS) or Chronic Tic Disorder (CTD) and their parents will be randomly assigned to receive either an Internet-based ICBIT or wait-list (WL).

详细描述

To evaluate the effect and acceptability of an Internet-based comprehensive behavioral intervention for tics (ICBIT) in a sample of children and adolescents with Tic disorders, children and adolescents (aged 8-17 years) with Tourette Syndrome (TS) or Chronic Tic Disorder (CTD) and their parents will be randomly assigned to receive either an Internet-based ICBIT or wait-list (WL) condition in a cross over design.

Participants will be randomized to ICBIT, or to wait list, and half will cross over from wait list to ICBT. Two blind independent clinical evaluators will rate tic severity and comorbidity. The primary outcome measure is the Yale Global Tic Severity Scale (YGTSS). Assessments will be performed at baseline, post-ICBT or post wait list, 3-months and 6-months (post-treatment for those originally assigned to ICBT) and post-ICBT, 3-months and 6-months (post-treatment for those originally assigned to wait list condition). All assessments were conducted by 2 PhD level independent child psychologists.

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
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
8 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of Tourette Syndrome or Chronic Tic Disorder.
  • Yale Global Tic Severity Scale tic severity score ≥14.

排除标准

  • Change in psychotropic medication regimen during the past 6 weeks.
  • Current diagnosis of substance abuse/dependence.
  • Lifetime diagnosis of pervasive developmental disorder, mania or psychosis.
  • Previous sessions of CBIT.

研究组 & 干预措施

CBIT

Experimental

ICBIT. Intervention delivered through an internet platform called Managing children's' tics (www.cbteamathome.co.il), based on CBIT protocol (Woods et al., 2008) adapted to an online parent-guided self-help format.

干预措施: ICBIT (Behavioral)

Waiting List

Placebo Comparator

Participants initially assigned to the wait list receive no psychosocial intervention for 9 weeks. Following post-WL assessment, all participants receive ICBIT.

干预措施: waiting list (Behavioral)

结局指标

主要结局

Yale Global Tic Severity Scale (YGTSS)

时间窗: change from baseline YGTSS total score at 3 months

次要结局

未报告次要终点

研究者

发起方
Tel Aviv Medical Center
申办方类型
Other
责任方
Principal Investigator
主要研究者

Michael Rotstein

Head, Pediatric Movement Disorder Clinic, Principal Investigator

Tel-Aviv Sourasky Medical Center

研究点 (2)

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