The Efficacy of Integrated Behavioral Therapy for Selective Mutism

NCT ID: NCT04585048

Last Updated: 2024-04-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-14
• Study Completion Date: 2023-03-01

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.

Conditions

Selective Mutism

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

waiting list

waiting list

Group Type: NO_INTERVENTION

No interventions assigned to this group

treatment

treatment with the Integrated Behavioral Therapy fo Selective Mutism

Group Type: EXPERIMENTAL

Integrated Behavioral Therapy for Selective Mutism

Intervention Type: BEHAVIORAL

Cognitive Behavioral treatment including 24 weekly sessions

Interventions

Integrated Behavioral Therapy for Selective Mutism

Cognitive Behavioral treatment including 24 weekly sessions

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rabin Medical Center

OTHER

Sponsor Role: lead

Responsible Party

alan apter

Prof. Alan Apter

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maayan shorer, PhD

Role: STUDY_DIRECTOR

Schneider Children's Medical Center, Israel

Locations

Schneider Childrens' Medical Center of Israel

Petah Tikva, , Israel

Countries

Israel

Other Identifiers

0210-15-RMC

Identifier Type: -

Identifier Source: org_study_id