NCT04233905

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 5, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 18, 2020

Completed
Last Updated

January 18, 2020

Status Verified

January 1, 2020

Enrollment Period

2 years

First QC Date

December 5, 2019

Last Update Submit

January 16, 2020

Conditions

Outcome Measures

Primary Outcomes (9)

  • 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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    24 months

Study Arms (4)

mute children

mute children and their mothers

Behavioral: Psychometric questionnaire study

healthy children

healthy children control group

Behavioral: Psychometric questionnaire study

mute adults

formerly mute adults

Behavioral: Psychometric questionnaire study

healthy adults

healthy adults control group

Behavioral: Psychometric questionnaire study

Interventions

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 adultshealthy childrenmute adultsmute children

Eligibility Criteria

Age8 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The sample consist of pupils with selective mutism aged 8 to 18 years.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Psychiatric University Clinics, Department of Child and Adolescent Psychiatry

Zurich, Canton of Zurich, 8032, Switzerland

Location

Related Publications (2)

  • 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.

MeSH Terms

Conditions

Mutism

Condition Hierarchy (Ancestors)

Speech DisordersLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental Disorders

Study Officials

  • Susanne Walitza, Prof. Dr. med. Dipl.-Psych.

    Sponsor-Investigator

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Head of the Department of Child and Adolescent Psychiatry

Study Record Dates

First Submitted

December 5, 2019

First Posted

January 18, 2020

Study Start

August 1, 2017

Primary Completion

July 31, 2019

Study Completion

July 31, 2019

Last Updated

January 18, 2020

Record last verified: 2020-01

Locations