The Efficacy of Integrated Behavioral Therapy for Selective Mutism

Selective Mutism Clinical Trial

Official title:

The Efficacy of Integrated Behavioral Therapy for Selective Mutism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04585048
• Other study ID #: 0210-15-RMC
• Status: Completed
• Phase: N/A
• Start date: May 14, 2017
• Est. completion date: March 1, 2023

Study information

• Verified date: April 2024
• Source: Rabin Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 1, 2023
• Est. primary completion date: May 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 8 Years

Eligibility

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

Related Conditions & MeSH terms

• Mutism
• Selective Mutism

Intervention

Behavioral:
• Integrated Behavioral Therapy for Selective Mutism
Cognitive Behavioral treatment including 24 weekly sessions

Locations

Country	Name	City	State
Israel	Schneider Childrens' Medical Center of Israel	Petach Tikva

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Selective Mutism Questionnaire	The change in parent's and teacher's report on child's selective Mutism symptoms	baseline, 1 week from baseline, 12 weeks from baseline, 24 weeks from baseline