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临床试验/NCT04585048
NCT04585048已完成不适用

The Efficacy of Integrated Behavioral Therapy for Selective Mutism

Rabin Medical Center1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年5月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Change in Selective Mutism Questionnaire

研究概览

简要总结

This study examines the efficacy of the Integrated Behavioral Therapy for Selective Mutism protocol (Bergman et al., 2013). Participants are 60 children, aged 4-8 years, diagnosed with Selective Mutism (SM). The level of SM symptoms is assessed during first arrival to the SM unit of Schneider Children's Medical Center of Israel (Intake), at the first treatment session, at sessions 12, and at the end of treatment.

A secondary aim of this study is to assess the contribution of parent's characteristics (anxiety and depression levels, parenting style) to the childrens' SM symptoms level and to treatment achievements.

详细描述

All study procedures have been approved by the Institutional Review Board of Schneider Children's Medical Center of Israel. Participants are recruited from the Selective Mutism unit at Schneider Children's Medical Center of Israel, during their first visit to the clinic. Both parents of eligible children sign informed consents. Each child is evaluated by a clinical psychologist, using a semi-structured interview (ADIS), designed to diagnose the child and to determine the level of symptom severity. The parents who are identified as the main-caregiving, complete questionnaires assessing the child's levels of SM symptoms and social anxiety (SMQ, SASC), the parents' levels of social anxiety (LSAS, SPIN) and depression (BDI), parent's authority style (PAQ), parental accommodation (FASA) and parental playfulness (PPQ). The child's teacher completes questionnaires assessing the child's SM levels (SSQ). Participants are than assigned either to the treatment or the waiting list group (by chance). The assessment of SM levels is repeated in both groups at 1 week from baseline, 12 weeks from baseline, and 24 weeks from baseline. participants of the waiting list group will commence treatment following the 24 weeks waiting period.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Selective Mutism diagnosis (DSM-5)
  • age 4-8 years

排除标准

  • Autism Spectum Disorder
  • Psychotic disorder
  • Commenced other psychiatric or psychological treatment at the last month

结局指标

主要结局

Change in Selective Mutism Questionnaire

时间窗: baseline, 1 week from baseline, 12 weeks from baseline, 24 weeks from baseline

The change in parent's and teacher's report on child's selective Mutism symptoms

次要结局

未报告次要终点

研究者

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

alan apter

Prof. Alan Apter

Rabin Medical Center

研究点 (1)

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