Factors Influencing Selective Mutism

Selective Mutism Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04233905
• Other study ID #: KJPP 2017-00679
• Status: Completed
• Start date: August 1, 2017
• Est. completion date: July 31, 2019

Study information

• Verified date: January 2020
• Source: Psychiatric University Hospital, Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: July 31, 2019
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Mutism
• Selective Mutism

Intervention

Behavioral:
• Psychometric questionnaire study
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.

Locations

Country	Name	City	State
Switzerland	Psychiatric University Clinics, Department of Child and Adolescent Psychiatry	Zurich	ZH

Sponsors (1)

Lead Sponsor	Collaborator
Susanne Walitza

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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