- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04233905
Factors Influencing Selective Mutism
January 16, 2020 updated by: Susanne Walitza
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
92
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
ZH
-
Zurich, ZH, Switzerland, 8032
- Psychiatric University Clinics, Department of Child and Adolescent Psychiatry
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
8 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
The sample consist of pupils with selective mutism aged 8 to 18 years.
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
mute children
mute children and their mothers
|
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.
|
healthy children
healthy children control group
|
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.
|
mute adults
formerly mute adults
|
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.
|
healthy adults
healthy adults control group
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
24 months
|
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.
|
24 months
|
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.
|
24 months
|
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.
|
24 months
|
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.
|
24 months
|
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.
|
24 months
|
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.
|
24 months
|
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.
|
24 months
|
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.
|
24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Susanne Walitza, Prof. Dr. med. Dipl.-Psych., Sponsor-Investigator
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Melfsen 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2017
Primary Completion (Actual)
July 31, 2019
Study Completion (Actual)
July 31, 2019
Study Registration Dates
First Submitted
December 5, 2019
First Submitted That Met QC Criteria
January 16, 2020
First Posted (Actual)
January 18, 2020
Study Record Updates
Last Update Posted (Actual)
January 18, 2020
Last Update Submitted That Met QC Criteria
January 16, 2020
Last Verified
January 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KJPP 2017-00679
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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