Selective MutismNCT00458198
Integrated Behavioral Therapy for Treating Children With Selective Mutism
A study testing Integrated behavioral therapy (BT) in people with Selective Mutism, run by University of California, Los Angeles at 1 site in United States.
Trial summary
This study will determine the effectiveness of integrated behavior therapy in treating children with selective mutism. 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 (BT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Jun 2009
- 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
- Diagnosis of selective mutism
- Score of less than 60 on the Childrens Global Assessment Scale (CGAS)
- Has lived continuously with a primary caretaker who has known the child well for at least 6 months prior to study entry and is legally able to sign the consent form
Who cannot join
- Diagnosis of any of the following psychiatric disorders: bipolar disorder, pervasive developmental disorder (e.g., Asperger's, autism), mental retardation, or psychotic disorder
- Possibility that a communication disorder may account for the selective mutism
- Current use of or a clinical indication for use of psychotropic medication (youth entering study on a stable psychostimulant regimen for ADHD will not be excluded)
- History of unsuccessful treatment with cognitive behavioral therapy for anxiety that occurred within 2 years prior to study entry
- Any major neurological disorder or major medical illness that may prevent study participation
- Child and/or parent is not English-speaking and is unable to complete measures or treatment without the assistance of a dedicated translator
- Child is not currently attending school (including pre-school), day camp, or other structured daily activity, or has missed more than 50% of school days in the 2 months prior to study entry
- Child's primary teacher is unwilling or unable to participate in the treatment plan
Trial locations and contacts
1 site in 1 country.
United States1 site
300 UCLA Medical Plaza
Los Angeles, California, 90095
About this study
Official title: Integrated Behavioral Treatment for Selective Mutism
This study will determine the effectiveness of integrated behavior therapy in treating children with selective mutism.
Read the detailed description
Selective mutism (SM) is a childhood behavior disorder that interferes with social and educational development. It is characterized by a persistent failure to speak in specific social situations, despite being able to speak in other situations. Children with SM typically speak when they are at home with immediate family, but fail to speak in other settings. Behavior therapy (BT), commonly used for treating anxiety disorders and phobias, is a type of treatment that uses training and desensitization methods to help patients become more comfortable in situations that cause anxiety. Based on available evidence, integrated BT, which involves parents, teachers, and the therapist, may be an effective treatment for SM. This study will determine the effectiveness of integrated BT in treating children with selective mutism.
Following a diagnostic assessment to determine eligibility, participants in this single-blind study will be randomly assigned to receive BT either immediately upon study entry or after a 3-month waiting period. BT will consist of 20 1-hour treatment sessions over 6 months. In BT, children will practice speaking to people with whom it has been difficult to speak in the past. Parents, teachers, and children will be taught about anxiety related to SM, setting treatment goals, monitoring anxiety, learning skills to relax, and gradually entering situations that may trigger anxiety. These skills will be practiced during treatment sessions, in school with other children and teachers, and at home on a daily basis. Both parents and teachers will record activities that children have been able to accomplish. In addition, participants will attend study visits at Weeks 8, 12, and 24 for assessments of outcomes.
Participants who are assigned to the waitlist group will not receive treatment during their first 3 months in the study. They will attend study visits at Weeks 8 and 12 to assess any improvement in symptoms. Participants whose symptoms do not improve by the end of the 3-month period may either stop participation or receive 6 months of BT.
All participants will attend one 2- to 3-hour follow-up visit 3 months post-treatment. This visit will include interviews and questionnaires about SM symptoms.
- Conditions
- Selective Mutism
- Being tested
- Integrated behavioral therapy (BT)
- Keywords
- 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 (BT)Behavioural
Participants in the BT condition will receive twenty 60-minute sessions over 24 weeks. Sessions will focus on graduated exposure to new speaking situations as the primary agent of anxiety reduction. Behavioral procedures will include systematic desensitization, shaping, and self-modeling procedures. Although a variety of exposure exercises will be routinely conducted in-session, any behavioral assignments will take place outside of session. Behavioral exercises will be implemented, as needed, in a modular fashion. For example, exercises may focus on speaking in-session to therapist, either at school or at home with others present. The therapist will be primarily responsible for developing the exposure parameters, but collaboration of parent, teacher, child will be emphasized increasingly over time. Reinforcement for attempts to complete assignments (contingency management program) will occur throughout treatment.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Participants will receive integrated behavioral therapy Receives: Behavioral: Integrated behavioral therapy (BT) |
| 2 | Active comparator | Participants will receive integrated behavioral therapy after a 12-week waitlist period Receives: Behavioral: Integrated behavioral therapy (BT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Selective Mutism Questionnaire
Measured: Measured at Weeks 8, 12, 24, and 36
Anxiety Disorders Interview Schedule (ADIS) Severity Rating
Measured: Measured at Weeks 8, 12, 24, and 36
Clinical Global Impression
Measured: Measured at Weeks 8, 12, 24, and 36
Secondary outcomes (1)
Strong Narrative Assessment Procedure
Measured: Measured at Weeks 8, 12, 24, and 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2007 (estimated)
- Study startJan 2006
- Primary completionJun 2008
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Selective MutismStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- R. Lindsey Bergman, PhD, Principal investigator, Semel Institute for Neuroscience & Human Behavior, Univeristy of California Los Angeles (UCLA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00458198
- Sponsor's protocol ID
- R34MH070938
- Other IDs
- R34MH070938, DDTR B3-PDX
- Status last verified
- Nov 2016
- First submitted
- 5 Apr 2007
- Last updated
- 28 Nov 2016
- Results posted
- No
Publications
Bergman RL, Gonzalez A, Piacentini J, Keller ML. Integrated Behavior Therapy for Selective Mutism: a randomized controlled pilot study. Behav Res Ther. 2013 Oct;51(10):680-9. doi: 10.1016/j.brat.2013.07.003. Epub 2013 Jul 16.
PubMed 23933108
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Behavioral Treatment for Selective Mutism
- ClinicalTrials.gov ID
- NCT00458198
- Acronym / sponsor ID
- R34MH070938
- Conditions
- Selective Mutism
- Keywords
- Selective Mutism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jan 2006
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 9 Apr 2007 (estimated)
- 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 will determine the effectiveness of integrated behavior therapy in treating children with selective mutism.
Detailed description
Selective mutism (SM) is a childhood behavior disorder that interferes with social and educational development. It is characterized by a persistent failure to speak in specific social situations, despite being able to speak in other situations. Children with SM typically speak when they are at home with immediate family, but fail to speak in other settings. Behavior therapy (BT), commonly used for treating anxiety disorders and phobias, is a type of treatment that uses training and desensitization methods to help patients become more comfortable in situations that cause anxiety. Based on available evidence, integrated BT, which involves parents, teachers, and the therapist, may be an effective treatment for SM. This study will determine the effectiveness of integrated BT in treating children with selective mutism.
Following a diagnostic assessment to determine eligibility, participants in this single-blind study will be randomly assigned to receive BT either immediately upon study entry or after a 3-month waiting period. BT will consist of 20 1-hour treatment sessions over 6 months. In BT, children will practice speaking to people with whom it has been difficult to speak in the past. Parents, teachers, and children will be taught about anxiety related to SM, setting treatment goals, monitoring anxiety, learning skills to relax, and gradually entering situations that may trigger anxiety. These skills will be practiced during treatment sessions, in school with other children and teachers, and at home on a daily basis. Both parents and teachers will record activities that children have been able to accomplish. In addition, participants will attend study visits at Weeks 8, 12, and 24 for assessments of outcomes.
Participants who are assigned to the waitlist group will not receive treatment during their first 3 months in the study. They will attend study visits at Weeks 8 and 12 to assess any improvement in symptoms. Participants whose symptoms do not improve by the end of the 3-month period may either stop participation or receive 6 months of BT.
All participants will attend one 2- to 3-hour follow-up visit 3 months post-treatment. This visit will include interviews and questionnaires about SM symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Integrated behavioral therapy (BT)Participants will receive integrated behavioral therapy |
| 2 | Active comparator | Behavioral: Integrated behavioral therapy (BT)Participants will receive integrated behavioral therapy after a 12-week waitlist period |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Diagnosis of selective mutism
- Score of less than 60 on the Childrens Global Assessment Scale (CGAS)
- Has lived continuously with a primary caretaker who has known the child well for at least 6 months prior to study entry and is legally able to sign the consent form
Key exclusion criteria (8 listed)
- Diagnosis of any of the following psychiatric disorders: bipolar disorder, pervasive developmental disorder (e.g., Asperger's, autism), mental retardation, or psychotic disorder
- Possibility that a communication disorder may account for the selective mutism
- Current use of or a clinical indication for use of psychotropic medication (youth entering study on a stable psychostimulant regimen for ADHD will not be excluded)
- History of unsuccessful treatment with cognitive behavioral therapy for anxiety that occurred within 2 years prior to study entry
- Any major neurological disorder or major medical illness that may prevent study participation
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 (BT)Participants in the BT condition will receive twenty 60-minute sessions over 24 weeks. Sessions will focus on graduated exposure to new speaking situations as the primary agent of anxiety reduction. Behavioral procedures will include systematic desensitization, shaping, and self-modeling procedures. Although a variety of exposure exercises will be routinely conducted in-session, any behavioral assignments will take place outside of session. Behavioral exercises will be implemented, as needed, in a modular fashion. For example, exercises may focus on speaking in-session to therapist, either at school or at home with others present. The therapist will be primarily responsible for developing the exposure parameters, but collaboration of parent, teacher, child will be emphasized increasingly over time. Reinforcement for attempts to complete assignments (contingency management program) will occur throughout treatment. | Behavioural | 1, 2 |
Primary outcome
Selective Mutism Questionnaire
Time frame: Measured at Weeks 8, 12, 24, and 36
Anxiety Disorders Interview Schedule (ADIS) Severity Rating
Time frame: Measured at Weeks 8, 12, 24, and 36
Clinical Global Impression
Time frame: Measured at Weeks 8, 12, 24, and 36
1 secondary outcome
Strong Narrative Assessment Procedure
Time frame: Measured at Weeks 8, 12, 24, and 36
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 28 Nov 2016.
- Results publication: PubMed 23933108Bergman RL, Gonzalez A, Piacentini J, Keller ML. Integrated Behavior Therapy for Selective Mutism: a randomized controlled pilot study. Behav Res Ther. 2013 Oct;51(10):680-9. doi: 10.1016/j.brat.2013.07.003. Epub 2013 Jul 16.
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.
R. Lindsey Bergman, PhD principal investigator
Semel Institute for Neuroscience & Human Behavior, Univeristy of California Los Angeles (UCLA)
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 (BT) in people with Selective Mutism, run by University of California, Los Angeles at 1 site in United States.
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 3 inclusion and 8 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 28 Nov 2016. 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 United States. 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?
Selective Mutism Questionnaire (time frame: Measured at Weeks 8, 12, 24, and 36). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00458198, which also lists 1 linked publication.
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 28 Nov 2016.