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Clinical Trials/NCT04585048
NCT04585048
Completed
N/A

The Efficacy of Integrated Behavioral Therapy for Selective Mutism

Rabin Medical Center1 site in 1 country60 target enrollmentMay 14, 2017

Overview

Phase
N/A
Intervention
Not specified
Conditions
Selective Mutism
Sponsor
Rabin Medical Center
Enrollment
60
Locations
1
Primary Endpoint
Change in Selective Mutism Questionnaire
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
May 14, 2017
End Date
March 1, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Sequential
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

alan apter

Prof. Alan Apter

Rabin Medical Center

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Change in Selective Mutism Questionnaire

Time Frame: 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

Study Sites (1)

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