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临床试验/NCT01002196
NCT01002196已完成2 期

How to Help When Silence is Not Golden A RCT Study of Selective Mutism

Regionsenter for barn og unges psykiske helse2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2009年6月1日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
24
试验地点
2
主要终点
School version of the Selective Mutism Questionnaire (SSQ)

研究概览

简要总结

Selective mutism (SM) describes inhibited and withdrawn children who are persistently mute in central situations despite ability to talk. SM may cause great suffering and create problems, both socially and related to learning. SM is associated with social anxiety, neurodevelopmental delay and bilingualism. The prevalence is about .7-8 ‰. Adequate assessment and treatment of SM is seldom provided in the mental health services. SM is considered hard to treat, and randomised treatment studies are lacking. This study will examine the effect of a manual based treatment for SM. The treatment consists of home- and kindergarten /school based interventions including behaviour techniques and psychoeducation. Defocused communication is a general treatment principle. Comorbidity, including neurodevelopmental delay /disorder, and predictors of outcome, will be examined. A pilot study was conducted to ensure the feasibility of the planned effectiveness study. Seven children, aged 3-5 years were included. Six has started treatment, and all talked in the kinder garden within the first 3 months. The present study will have a randomised controlled design with 1. Manual based intervention for 6 months compared to 2. Waiting list controls (3 months), and then manual based intervention. The sample: Children aged 3-9 years consecutively referred to the school psychology- or the mental health services in Oslo and Eastern Norway. Expected N = 24 based on the pilot study, is a sufficient sample size to answer our primary research question. The treatment will be given by a therapist from the research group or by a local clinician under supervision. The study can add essential knowledge on treatment of SM and make effective treatment available to clinicians in the community.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
3 Years 至 9 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children from Eastern & Southern Norway will be included if they fulfill the diagnostic criteria for SM

排除标准

  • Children with SM and mental retardation with IQ below
  • Children with SM and psychosis or pervasive developmental disorders with the exception of Asperger syndrome and PDD Nos (DSM-IV)
  • Children with SM who receive an active treatment for SM in the CAMHS
  • Children with SM who are medicated for social anxiety.
  • Children with SM where the parents do not understand Norwegian.

结局指标

主要结局

School version of the Selective Mutism Questionnaire (SSQ)

时间窗: at 3, 6, 12 months

次要结局

  • Clinical Global Impression Scale (CGI)(at 3, 6, 12 months)

研究者

发起方
Regionsenter for barn og unges psykiske helse
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hanne Kristensen

Director Section for Clinical Research

Regionsenter for barn og unges psykiske helse

研究点 (2)

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