Selective MutismNCT04233905
Factors Influencing Selective Mutism
An observational study of Selective Mutism, run by Susanne Walitza at 1 site in Switzerland.
Trial summary
The study's goal is to check and verify basic assumptions of a new selective mutism developmental model from Melfsen and Walitza through standardized and routinely used patient questionnaires. Read more about this study
- Who is it for?
- Ages 8 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Selective Mutism
- What is being tested?
- Psychometric questionnaire study
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 92 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Aug 2017to 31 Jul 2019
- Phase
- Observational
- 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 8 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: The sample consist of pupils with selective mutism aged 8 to 18 years.
Who may be able to join
- Children and young people from 8-18 years of age who fulfill the international classification of diseases tenth edition (ICD-10) for selective mutism
- Adults who suffered selective mutism when they were children or adolescents
- All study participants or their legal representative have given written permission for their experiences to be documented in the study.
Who cannot join
- Temporary mutism, e.g. from emotional disturbances or separation anxiety (F93.0), or depression
- Profound developmental disturbances (F84.2) like early childhood autism (F84.0), atypical autism (F84.1), Rett Syndrome (F84.2), alternative disintegrative childhood disturbances (F84.3), hyperactivity disturbance with decrease of intelligence and movement stereotypes (F84.5), or Asperger's Syndrome.
- Schizophrenia (F20)
- Profound mental retardation
- Delineated development disturbances of speech and language (F80)
- Organic brain disease with loss of language or disturbance of speech development
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Psychiatric University Clinics, Department of Child and Adolescent Psychiatry
Zurich, Canton of Zurich, 8032
About this study
Official title: A Psychometric Questionnaire Study With a Control Group Design of Children and Young People With Selective Mutism, as Well as on Adults Who Suffered Selective Mutism Earlier in Life
The study's goal is to check and verify basic assumptions of a new selective mutism developmental model from Melfsen and Walitza through standardized and routinely used patient questionnaires. The primary emphasis is the question of a connection between selective mutism and high sensitivity, dissociation, emotional regulation, family structure, social anxiety and self-esteem.
- Conditions
- Selective Mutism
- Being tested
- Psychometric questionnaire study
- Medical subject headings
- Mutism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychometric questionnaire studyBehavioural
Four groups participate in the psychometric questionnaire study. A group of mute children and their mothers (EG:A), as well as a normal, healthy control group (KG:A) with roughly the same age and sex characteristics fill out one-time questionnaires about current daily life experiences. In addition, another group of formerly mute adults (EG:B) as well as a comparable age/sex normal control group will be retrospectively questioned using the same specifically tailored questionnaire.
| Study group | Role | What they receive |
|---|---|---|
| mute children | mute children and their mothers Receives: Behavioral: Psychometric questionnaire study | |
| healthy children | healthy children control group Receives: Behavioral: Psychometric questionnaire study | |
| mute adults | formerly mute adults Receives: Behavioral: Psychometric questionnaire study | |
| healthy adults | healthy adults control group Receives: Behavioral: Psychometric questionnaire study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptoms severity of selective mutism
The parent report "Selective Mutism Questionnaire (SMQ)" is a 17-item parent-rating measure designed to assess the severity of selective mutism. The test uses a 4-point scale to rate the frequency of the child's speaking behaviour in school (6 items), home/family (6 items) and public settings outside school (5 items) from 0 (never) to 3 (always) each, with a total score of 51. Higher score means a worse outcome.
Measured: 24 months
High sensitivity
The "Highly Sensitive Person Scale" (HSP) is a self-report questionnaire with 27 items to be answered on a seven-point Likert scale (from 1 "not at all" to 7 "absolutely"). The total score divided by item number ranges from 0 to 7. Higher score means a worse outcome.
Measured: 24 months
Family relation structure
The "Parent-Image-Questionnaire for Children and Adolescents (EBF-KJ)" is a self-reporting questionnaire for children and adolescents to record the family relationship structure with 36 items on a five-point Likert scale from 0 (never) to 4 (always). Higher score means a stronger characteristic.
Measured: 24 months
Emotion regulation
Emotion regulation is measured using the German questionnaire "Fragebogen zur Erhebung der Emotionsregulation bei Kindern und Jugendlichen (FEEL-KJ). It is a multi-dimensional tool for the emotion-specific detection of emotion regulation strategies. It measures fear, sadness and anger. Adaptive strategies include problem-oriented behavior, dispersion, mood elevation, acceptance, forgetting, revaluation and cognitive problem solving. Maladaptive strategies include abandonment, aggressive behavior, withdrawal, self-devaluation and perseveration. A total of 90 items is to be rated on the basis of a five-level rating scale with regard to their frequency. Higher scores mean more adaptive or maladaptive strategies.
Measured: 24 months
Symptoms of selective mutism
Symptom severity is assessed by using the "Checklist for speaking behaviour, parent report" (CheckS). It assesses the communicative burden of various socially interactive situations for children suffering from selective mutism on a five-point scale (from 0 = "never" to 4 = "always"). A distinction is made between different contexts, namely the persons to be spoken to, the type of communication, the length of the spoken answers, the conversational situations, the contents of the conversation, the places and surroundings, the expectations of those present and the unpredictability of contexts. The total score ranges from 0 to 4.Higher score means a worse outcome.
Measured: 24 months
Dissociation
The German translation of the "Child Dissociative Checklist" (CDC) is a parent report of 20 items using a three-point Likert scale (0 = "very true", 1 ="somewhat true", 2 ="not true"). Parents are asked to report dissociative behavioural problems of their child within the past 12 months. Higher score means a worse outcome.
Measured: 24 months
Dissociation
The children and adolescents completed the "Self-Perception Questionnaire for Children and Adolescents" (A-DES) to assess dissociative symptoms. 30 items are to be assessed on an 11-point rating scale (from 0 = "never" to 10 = "always") in terms of their frequency. Higher score means a worse outcome.
Measured: 24 months
Social anxiety
The German version of the "Social phobia and anxiety inventory for children (SPAIK) is used to asses social anxiety in children and adolescents. The questionnaire consists of 26 situations assessing somatic, cognitive and behavioural aspects of social anxiety. They measure characteristic aspects of social anxiety on a three-point Likert scale (from 0 = "never or seldom" to 3 = "most of the time or always") with a total score of 52. Higher score means a worse outcome.
Measured: 24 months
Self-esteem
The "List of statements on self-esteem for children and adolescents" (ALS) uses the same 18 items to differentiate the self-esteem of children and adolescents in three areas: family, school and leisure. Higher score means a stronger self-esteem.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start1 Aug 2017
- Primary completion31 Jul 2019
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Susanne Walitza
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Susanne Walitza, Psychiatric University Hospital, Zurich
- Investigators
- Susanne Walitza, Prof. Dr. med. Dipl.-Psych., Principal investigator, Sponsor-Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04233905
- Sponsor's protocol ID
- KJPP 2017-00679
- Status last verified
- Jan 2020
- First submitted
- 5 Dec 2019
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Melfsen S, Jans T, Romanos M, Walitza S. Emotion regulation in selective mutism: A comparison group study in children and adolescents with selective mutism. J Psychiatr Res. 2022 Jul;151:710-715. doi: 10.1016/j.jpsychires.2022.05.040. Epub 2022 May 24.
PubMed 35690008Melfsen S, Romanos M, Jans T, Walitza S. Betrayed by the nervous system: a comparison group study to investigate the 'unsafe world' model of selective mutism. J Neural Transm (Vienna). 2021 Sep;128(9):1433-1443. doi: 10.1007/s00702-021-02404-1. Epub 2021 Aug 14.
PubMed 34390394
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Psychometric Questionnaire Study With a Control Group Design of Children and Young People With Selective Mutism, as Well as on Adults Who Suffered Selective Mutism Earlier in Life
- ClinicalTrials.gov ID
- NCT04233905
- Acronym / sponsor ID
- KJPP 2017-00679
- Conditions
- Selective Mutism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Susanne WalitzaUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 18 Jan 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.
The study's goal is to check and verify basic assumptions of a new selective mutism developmental model from Melfsen and Walitza through standardized and routinely used patient questionnaires. The primary emphasis is the question of a connection between selective mutism and high sensitivity, dissociation, emotional regulation, family structure, social anxiety and self-esteem.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| mute children | – | Behavioral: Psychometric questionnaire studymute children and their mothers |
| healthy children | – | Behavioral: Psychometric questionnaire studyhealthy children control group |
| mute adults | – | Behavioral: Psychometric questionnaire studyformerly mute adults |
| healthy adults | – | Behavioral: Psychometric questionnaire studyhealthy adults control group |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- The sample consist of pupils with selective mutism aged 8 to 18 years.
Key inclusion criteria (3 listed)
- Children and young people from 8-18 years of age who fulfill the international classification of diseases tenth edition (ICD-10) for selective mutism
- Adults who suffered selective mutism when they were children or adolescents
- All study participants or their legal representative have given written permission for their experiences to be documented in the study.
Key exclusion criteria (6 listed)
- Temporary mutism, e.g. from emotional disturbances or separation anxiety (F93.0), or depression
- Profound developmental disturbances (F84.2) like early childhood autism (F84.0), atypical autism (F84.1), Rett Syndrome (F84.2), alternative disintegrative childhood disturbances (F84.3), hyperactivity disturbance with decrease of intelligence and movement stereotypes (F84.5), or Asperger's Syndrome.
- Schizophrenia (F20)
- Profound mental retardation
- Delineated development disturbances of speech and language (F80)
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 |
|---|---|---|
| Psychometric questionnaire studyFour groups participate in the psychometric questionnaire study. A group of mute children and their mothers (EG:A), as well as a normal, healthy control group (KG:A) with roughly the same age and sex characteristics fill out one-time questionnaires about current daily life experiences. In addition, another group of formerly mute adults (EG:B) as well as a comparable age/sex normal control group will be retrospectively questioned using the same specifically tailored questionnaire. | Behavioural | healthy adults, healthy children, mute adults, mute children |
Primary outcome
Symptoms severity of selective mutism
Time frame: 24 months
The parent report "Selective Mutism Questionnaire (SMQ)" is a 17-item parent-rating measure designed to assess the severity of selective mutism. The test uses a 4-point scale to rate the frequency of the child's speaking behaviour in school (6 items), home/family (6 items) and public settings outside school (5 items) from 0 (never) to 3 (always) each, with a total score of 51. Higher score means a worse outcome.
High sensitivity
Time frame: 24 months
The "Highly Sensitive Person Scale" (HSP) is a self-report questionnaire with 27 items to be answered on a seven-point Likert scale (from 1 "not at all" to 7 "absolutely"). The total score divided by item number ranges from 0 to 7. Higher score means a worse outcome.
Family relation structure
Time frame: 24 months
The "Parent-Image-Questionnaire for Children and Adolescents (EBF-KJ)" is a self-reporting questionnaire for children and adolescents to record the family relationship structure with 36 items on a five-point Likert scale from 0 (never) to 4 (always). Higher score means a stronger characteristic.
Emotion regulation
Time frame: 24 months
Emotion regulation is measured using the German questionnaire "Fragebogen zur Erhebung der Emotionsregulation bei Kindern und Jugendlichen (FEEL-KJ). It is a multi-dimensional tool for the emotion-specific detection of emotion regulation strategies. It measures fear, sadness and anger. Adaptive strategies include problem-oriented behavior, dispersion, mood elevation, acceptance, forgetting, revaluation and cognitive problem solving. Maladaptive strategies include abandonment, aggressive behavior, withdrawal, self-devaluation and perseveration. A total of 90 items is to be rated on the basis of a five-level rating scale with regard to their frequency. Higher scores mean more adaptive or maladaptive strategies.
Symptoms of selective mutism
Time frame: 24 months
Symptom severity is assessed by using the "Checklist for speaking behaviour, parent report" (CheckS). It assesses the communicative burden of various socially interactive situations for children suffering from selective mutism on a five-point scale (from 0 = "never" to 4 = "always"). A distinction is made between different contexts, namely the persons to be spoken to, the type of communication, the length of the spoken answers, the conversational situations, the contents of the conversation, the places and surroundings, the expectations of those present and the unpredictability of contexts. The total score ranges from 0 to 4.Higher score means a worse outcome.
Dissociation
Time frame: 24 months
The German translation of the "Child Dissociative Checklist" (CDC) is a parent report of 20 items using a three-point Likert scale (0 = "very true", 1 ="somewhat true", 2 ="not true"). Parents are asked to report dissociative behavioural problems of their child within the past 12 months. Higher score means a worse outcome.
Dissociation
Time frame: 24 months
The children and adolescents completed the "Self-Perception Questionnaire for Children and Adolescents" (A-DES) to assess dissociative symptoms. 30 items are to be assessed on an 11-point rating scale (from 0 = "never" to 10 = "always") in terms of their frequency. Higher score means a worse outcome.
Social anxiety
Time frame: 24 months
The German version of the "Social phobia and anxiety inventory for children (SPAIK) is used to asses social anxiety in children and adolescents. The questionnaire consists of 26 situations assessing somatic, cognitive and behavioural aspects of social anxiety. They measure characteristic aspects of social anxiety on a three-point Likert scale (from 0 = "never or seldom" to 3 = "most of the time or always") with a total score of 52. Higher score means a worse outcome.
Self-esteem
Time frame: 24 months
The "List of statements on self-esteem for children and adolescents" (ALS) uses the same 18 items to differentiate the self-esteem of children and adolescents in three areas: family, school and leisure. Higher score means a stronger self-esteem.
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 18 Jan 2020.
- Derived from this study: PubMed 35690008Melfsen S, Jans T, Romanos M, Walitza S. Emotion regulation in selective mutism: A comparison group study in children and adolescents with selective mutism. J Psychiatr Res. 2022 Jul;151:710-715. doi: 10.1016/j.jpsychires.2022.05.040. Epub 2022 May 24.
- Derived from this study: PubMed 34390394Melfsen S, Romanos M, Jans T, Walitza S. Betrayed by the nervous system: a comparison group study to investigate the 'unsafe world' model of selective mutism. J Neural Transm (Vienna). 2021 Sep;128(9):1433-1443. doi: 10.1007/s00702-021-02404-1. Epub 2021 Aug 14.
- Individual participant dataSharing planned: Undecided
Related trials for Selective Mutism
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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.
Susanne Walitza, Prof. Dr. med. Dipl.-Psych. principal investigator
Sponsor-Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Selective Mutism, run by Susanne Walitza at 1 site in Switzerland.
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 6 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 18 Jan 2020. 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 Switzerland. 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?
Symptoms severity of selective mutism (time frame: 24 months). The study lists 9 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 NCT04233905, which also lists 2 linked publications.
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 18 Jan 2020.