Clinical trial NCT04233905: Factors Influencing Selective Mutism
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Selective Mutism
Lead sponsor: Psychiatric University Hospital, Zurich
Sponsor class: OTHER
First posted: 2020-01-18
Enrollment: 92
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The sample consist of pupils with selective mutism aged 8 to 18 years.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Symptoms severity of selective mutism
timeFrame: 24 months
measure: High sensitivity
timeFrame: 24 months
measure: Family relation structure
timeFrame: 24 months
measure: Emotion regulation
timeFrame: 24 months
measure: Symptoms of selective mutism
timeFrame: 24 months
measure: Dissociation
timeFrame: 24 months
measure: Dissociation
timeFrame: 24 months
measure: Social anxiety
timeFrame: 24 months
measure: Self-esteem
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Psychiatric University Clinics, Department of Child and Adolescent Psychiatry
state: ZH
Study officials:
affiliation: Sponsor-Investigator
name: Susanne Walitza, Prof. Dr. med. Dipl.-Psych.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.