The Efficacy of Integrated Behavioral Therapy for Selective Mutism

NCT04585048 | Completed

• 1 other identifier: 0210-15-RMC
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Selective Mutism

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

waiting list

NO INTERVENTION

waiting list

treatment

EXPERIMENTAL

treatment with the Integrated Behavioral Therapy fo Selective Mutism

Behavioral: Integrated Behavioral Therapy for Selective Mutism

Interventions

Integrated Behavioral Therapy for Selective Mutism BEHAVIORAL

Cognitive Behavioral treatment including 24 weekly sessions

treatment

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Rabin Medical Center: lead

Study Sites (1)

Schneider Childrens' Medical Center of Israel

Petah Tikva, Israel

Location

MeSH Terms

Conditions

Mutism

Condition Hierarchy (Ancestors)

Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Maayan shorer, PhD

  Schneider Children's Medical Center, Israel

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Alan Apter

Model Details: waiting list vs. treatment phase

Study Record Dates

• First Submitted: February 10, 2019
• First Posted: October 14, 2020
• Study Start: May 14, 2017
• Primary Completion: May 1, 2021
• Study Completion: March 1, 2023
• Last Updated: April 16, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)