The Efficacy of Integrated Behavioral Therapy for Selecti... | NCT04585048

Studies
The Efficacy of Integrated Behavioral Therapy for Selective Mutism

NCT04585048

Sponsor

Rabin Medical Center

Status

Completed

Last Update Posted

Apr 16, 2024Actual

Enrollment

60Actual

Phase

Not Applicable

Conditions

Selective Mutism

Interventions

Integrated Behavioral Therapy for Selective Mutism

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 14, 2017Actual

Primary Completion Date

May 1, 2021Actual

Completion Date

Mar 1, 2023Actual

First Submitted Date

Feb 10, 2019

First Submission Date that Met QC Criteria

Oct 10, 2020

First Posted Date

Oct 14, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 15, 2024

Last Update Posted Date

Apr 16, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

alan apter, Prof. Alan Apter, Rabin Medical CenterPrincipal Investigator

Lead Sponsor

Rabin Medical CenterOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Integrated Behavioral Therapy for Selective Mutism	Behavioral	Cognitive Behavioral treatment including 24 weekly sessions	treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

4 Years

Maximum Age

8 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Maayan shorer, PhD	Schneider Children's Medical Center, Israel	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Schneider Childrens' Medical Center of Israel		Petah Tikva			Israel

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009155	Mutism

Ancestor Terms

ID	Term
D013064	Speech Disorders
D007806	Language Disorders
D003147	Communication Disorders
D019954	Neurobehavioral Manifestations

Browse Leaves

Not provided

Browse Branches

Not provided