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The Efficacy of Integrated Behavioral Therapy for Selective Mutism

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Clalit Health Services

Status

Completed

Conditions

Selective Mutism

Treatments

Behavioral: Integrated Behavioral Therapy for Selective Mutism

Study type

Interventional

Funder types

Other

Identifiers

NCT04585048
0210-15-RMC

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 patients

Sex

All

Ages

4 to 8 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

60 participants in 2 patient groups

waiting list
No Intervention group
Description:
waiting list
treatment
Experimental group
Description:
treatment with the Integrated Behavioral Therapy fo Selective Mutism
Treatment:
Behavioral: Integrated Behavioral Therapy for Selective Mutism

Trial contacts and locations

1

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Central trial contact

Maayan shorer, PhD

Data sourced from clinicaltrials.gov

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