Emotion regulation in children with selective mutism: Project Omilía

Recruiting

Conditions: Elective mutisme (ICD-10)
Selective mutisme (DSM-5)
10002861

Registration Number: NL-OMON52684

Lead Sponsor: niversiteit Leiden

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 88

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all
of the following criteria:All children:
Both parents signed informed consent
Adequate command of the Dutch language
Age between 4,0 and 8,11 years Selective mutism group:
Diagnosis selective mutism
Confirmed diagnosis based on the Selective Mutism Questionnaire (SMQ; Bergman,
Keller, Piacentini, & Bergman, 2008; Letamendi et al., 2008) and the Anxiety
Disorders Interview Schedule (ADIS-IV; Silverman & Albano, 1996).

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded
from participation in this study:All children:
History of brain trauma or neurological illness
Hearing problemsSelective mutism group:
Mutism as a result of other pathology, for example, severe speech, language, or
attachment disorder or trauma.Typically developing children:
Concern about psychopathology reported by parents on the Strengths and
Difficulties Questionnaire (SDQ; Goodman, 1997).

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Endpoints:<br /><br><br /><br>• (Social) Anxiety as expressed in heart-rate and skin conductance measures (%<br /><br>change in beats per minute (HR), heart rate variability (HRV),<br /><br>pre-ejection period (PEP), Respiratory sinus arrhythmia (RSA) and skin<br /><br>conductance level)<br /><br>• Social information processing, as expressed in the duration and fixation<br /><br>towards social stimuli measured with eyetracking.<br /><br>• Level of stress as expressed in HPA-axis responsivity (baseline cortisol<br /><br>level (saliva), cortisol reactivity levels (saliva), chronical cortisol levels<br /><br>(hair)<br /><br>• Performance on (neuro)psychological test scores (accuracy, reaction times)<br /><br>• Behavioural reports using questionnaires in Qualtrics (sumscores)<br /><br>• Behaviour observations (video recorded) (sumscores)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Differences in the variables between groups (listed below) may either cause or<br /><br>mask differences on variables of interest and therefore need to be controlled<br /><br>for.<br /><br><br /><br>Child*s background information:<br /><br>• Age<br /><br>• Gender<br /><br>• Immigrant status<br /><br>• Multilingualism<br /><br>• Confirming clinical diagnoses using a structured parental interview i.e.,<br /><br>Subscale selective mutism of ADIS (dichotome score)<br /><br><br /><br>Parents background information:<br /><br>• Level of anxiety and stress parents<br /><br>• Socioeconomic status (SES) </p><br>