The Efficacy of Integrated Behavioral Therapy for Selective Mutism
Primary Purpose
Selective Mutism
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Integrated Behavioral Therapy for Selective Mutism
Sponsored by
About this trial
This is an interventional treatment trial for Selective Mutism
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
Sites / Locations
- Schneider Childrens' Medical Center of IsraelRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
waiting list
treatment
Arm Description
waiting list
treatment with the Integrated Behavioral Therapy fo Selective Mutism
Outcomes
Primary Outcome Measures
Change in Selective Mutism Questionnaire
The change in parent's and teacher's report on child's selective Mutism symptoms
Secondary Outcome Measures
Full Information
NCT ID
NCT04585048
First Posted
February 10, 2019
Last Updated
October 10, 2020
Sponsor
Rabin Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT04585048
Brief Title
The Efficacy of Integrated Behavioral Therapy for Selective Mutism
Official Title
The Efficacy of Integrated Behavioral Therapy for Selective Mutism
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 14, 2017 (Actual)
Primary Completion Date
May 1, 2021 (Anticipated)
Study Completion Date
May 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rabin Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Selective Mutism
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
waiting list vs. treatment phase
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
waiting list
Arm Type
No Intervention
Arm Description
waiting list
Arm Title
treatment
Arm Type
Experimental
Arm Description
treatment with the Integrated Behavioral Therapy fo Selective Mutism
Intervention Type
Behavioral
Intervention Name(s)
Integrated Behavioral Therapy for Selective Mutism
Intervention Description
Cognitive Behavioral treatment including 24 weekly sessions
Primary Outcome Measure Information:
Title
Change in Selective Mutism Questionnaire
Description
The change in parent's and teacher's report on child's selective Mutism symptoms
Time Frame
baseline, 1 week from baseline, 12 weeks from baseline, 24 weeks from baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maayan shorer, PhD
Phone
+972523402547
Email
maayans@clalit.org.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maayan shorer, PhD
Organizational Affiliation
Schneider Children's Medical Center, Israel
Official's Role
Study Director
Facility Information:
Facility Name
Schneider Childrens' Medical Center of Israel
City
Petach Tikva
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maayan Shorer, PhD
Phone
+97239253864
Email
maayans@clalit.org.il
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Efficacy of Integrated Behavioral Therapy for Selective Mutism
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