Selective MutismNCT04585048
The Efficacy of Integrated Behavioral Therapy for Selective Mutism
A study testing Integrated Behavioral Therapy for Selective Mutism in people with Selective Mutism, run by Rabin Medical Center at 1 site in Israel.
Trial 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). Read more about this study
- Who is it for?
- Ages 4 to 8 years
- Conditions the study is for
- Selective Mutism
- What is being tested?
- Integrated Behavioral Therapy for Selective Mutism
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- 14 May 2017to 1 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Selective Mutism diagnosis (DSM-5)
- age 4-8 years
Who cannot join
- Autism Spectum Disorder
- Psychotic disorder
- Commenced other psychiatric or psychological treatment at the last month
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Integrated Behavioral Therapy for Selective Mutism
- Medical subject headings
- Mutism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated Behavioral Therapy for Selective MutismBehavioural
Cognitive Behavioral treatment including 24 weekly sessions
| Study group | Role | What they receive |
|---|---|---|
| waiting list | No intervention | waiting list |
| treatment | Experimental | treatment with the Integrated Behavioral Therapy fo Selective Mutism Receives: Behavioral: Integrated Behavioral Therapy for Selective Mutism |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Selective Mutism Questionnaire
The change in parent's and teacher's report on child's selective Mutism symptoms
Measured: baseline, 1 week from baseline, 12 weeks from baseline, 24 weeks from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start14 May 2017
- Primary completion1 May 2021
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Selective MutismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- waiting list vs. treatment phase
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, alan apter, Rabin Medical Center
- Investigators
- Maayan shorer, PhD, Study director, Schneider Children's Medical Center, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04585048
- Sponsor's protocol ID
- 0210-15-RMC
- Status last verified
- Apr 2024
- First submitted
- 10 Feb 2019
- Last updated
- 16 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Integrated Behavioral Therapy for Selective Mutism
- ClinicalTrials.gov ID
- NCT04585048
- Acronym / sponsor ID
- 0210-15-RMC
- Conditions
- Selective Mutism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- 14 May 2017 (actual)
- Primary completion
- 1 May 2021 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 14 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- waiting list vs. treatment phase
| Arm | Type | Receives |
|---|---|---|
| waiting list | No intervention | –waiting list |
| treatment | Experimental | Behavioral: Integrated Behavioral Therapy for Selective Mutismtreatment with the Integrated Behavioral Therapy fo Selective Mutism |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Selective Mutism diagnosis (DSM-5)
- age 4-8 years
Key exclusion criteria (3 listed)
- Autism Spectum Disorder
- Psychotic disorder
- Commenced other psychiatric or psychological treatment at the last month
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Integrated Behavioral Therapy for Selective MutismCognitive Behavioral treatment including 24 weekly sessions | Behavioural | treatment |
Primary outcome
Change in Selective Mutism Questionnaire
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
- Individual participant dataSharing planned: No
Related trials for Selective Mutism
Recruiting
VR Homework Exercises for Selective Mutism Treatment
Selective Mutism, Anxiety Disorder of Childhood
Recruiting
Testing Delivery Modalities of Team-Based CBT for Pediatric Anxiety in Community Health Settings.
Obsessive Compulsive Disorder (OCD), Pediatric Anxiety Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maayan shorer, PhD study director
Schneider Children's Medical Center, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrated Behavioral Therapy for Selective Mutism in people with Selective Mutism, run by Rabin Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Selective Mutism Questionnaire (time frame: baseline, 1 week from baseline, 12 weeks from baseline, 24 weeks from baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2024.