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Emotion regulation in children with selective mutism: Project Omilía

Emotion regulation in children with selective mutism: Project Omilía - Project Omilía

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON52684
Enrollment
88
Registered
2019-09-25
Start date
2021-09-07
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Elective mutisme (ICD-10) Selective mutisme (DSM-5)

Interventions

None listed

Sponsors

Universiteit Leiden
Lead Sponsor

Eligibility

Age
2 Years to 11 Years

Inclusion criteria

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

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).

Design outcomes

Primary

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

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)