The Efficacy of Integrated Behavioral Therapy for Selective Mutism

Not Applicable

Completed

• Conditions: Selective Mutism
• Interventions: Behavioral: Integrated Behavioral Therapy for Selective Mutism

• Registration Number: NCT04585048
• Lead Sponsor: Rabin Medical Center

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.

Study Timeline

• Study Start: 2017-05-14
• Study First Submitted: 2019-02-10
• Study First Submitted QC: 2020-10-10
• Study First Posted: 2020-10-14
• Primary Completion: 2021-05-01
• Study Completion: 2023-03-01
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-15
• Last Update Posted: 2024-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
treatment	Integrated Behavioral Therapy for Selective Mutism	treatment with the Integrated Behavioral Therapy fo Selective Mutism

Primary Outcome Measures

Name	Time	Method
Change in Selective Mutism Questionnaire	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

Trial Locations

Locations (1)

Schneider Childrens' Medical Center of Israel; 🇮🇱 Petach Tikva, Israel