Objective: Study 1: T0 case-control observational study1) Explore if the failure to speak in specific social situations is associated with social anxiety as expressed by autonomic emotional arousal.2) To assess if the failure to speak in specific…
ID
Source
Brief title
Condition
- Anxiety disorders and symptoms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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)
Background summary
Selective mutism (SM) is a relatively rare, psychiatric condition typically
occurring during childhood. It is characterized by a persistent absence of
speech in specific public situations in which the child is expected to speak
(e.g., school, social situations), whereas in other situations (e.g., at home),
speech production is unaffected (American Psychiatric Association, 2013). The
latest edition of the Diagnostic and Statistical Manual of Mental Disorders
(DSM-5) conceptualizes SM as an anxiety disorder. However, aetiology of SM is
still poorly understood, since controlled studies with sufficient power are
scarce.
To date, SM is broadly understood as multifactorial, i.e., as caused by
biological, psychological and or environmental factors. Many of the causal
factors have also been implicated in the origins of other anxiety pathologies
(e.g., Peter Muris, 2010), which strengthens the conceptualization of SM as an
anxiety disorder but weakens our understanding of disorder-specific factors in
this unique population. The most plausible mechanisms underlying the persistent
failure to speak are avoidance of difficulties experienced as a consequence of
(neuro)developmental problems e.g., social, communication difficulties, and/or
avoidance of negative consequences of speaking e.g., feedback, social anxiety
(P. Muris & Ollendick, 2015). We believe the way forward to improve etiological
insights is to study SM from an emotion dysregulation- and neurodevelopmental
perspective. With this proposal we will address key gaps in the aetiology of SM
regarding A) mechanisms underlying neurodevelopmental difficulties, using
cognitive building blocks from the SOCIAL model by Beauchamp and Anderson
(2010) and B) emotional arousal and distress (neurobiological functioning)
underlying the failure to speak in children suffering from SM, using
psychophysiological assessment methods. Finally, we follow-up on symptoms over
time and explore if changes in symptoms are associated with / or can be
predicted by cognitive and / or neurobiological functioning. Study results are
expected to be of value in designing improved therapeutic interventions for
children with SM. In addition, the insights obtained within this study will
help to inform parents, teachers and clinicians.
Study objective
Objective:
Study 1: T0 case-control observational study
1) Explore if the failure to speak in specific social situations is associated
with social anxiety as expressed by autonomic emotional arousal.
2) To assess if the failure to speak in specific social situations is
correlated with cognitive control and receptive language skills in children
suffering from selective mutism.
3) To explore if the failure to speak in specific social situations can be
predicted by social information processing biases in children with selective
mutism.
Study 2: T1 longitudinal study
7) To investigate whether reduction of symptoms over time is associated with a
change in social anxiety as expressed by autonomic emotional
arousal.
8) To assess if specific markers of autonomic arousal predict symptom outcomes
at one year follow-up in children suffering from selective
mutism.
9) To assess if reduction of symptoms over time can be predicted by cognitive
control, and/or language and are associated with changes in
social information processing in children with selective mutism.
Study design
This is a longitudinal study, including case-control observations.
Study 1: T0 case-control observational study
We aim to compare emotion regulation, as well as cognitive and affective
mechanisms that are assumed to underlie the failure to speak in social
situations in children with SM to and non-anxious (NON-ANX) controls.
Study 2: T1 longitudinal study
We aim to investigate if symptom reduction over time effects arousal or can be
predicted by cognitive and affective functioning in children with SM as
compared to typical development in the non-anxious control group (pre-post-test
design).
Study burden and risks
This is a outreaching study having the advantage of a minimal burden to
participants (e.g., no traveling or babysitter required) and maximum study
performance in familiar environment (e.g., less distress). Because we aim to
identify how functioning, arousal, stressresponsivness, cognition and social
information processing of children with SM differs from children with other
anxiety disorders, it is necessary to to include a comparison group of children
with an anxiety disorder other than selective mutism, matched on age. A
typically developing, niet angstige group of children is needed in order to
quantify to what degree children with SM differ from typically developing
(non-anxious) children.
There are no risks involved. The burden includes time investment, with
respectively 2 x 100 minutes105 minutes per assessment. Time investment for
parents ranges between 85 to 135 minutes, and consists of a short interview and
filling out questionnaires. Child assessments include behavior observations,
neuropsychological tests, eye-tracking, and arousal measures (heart-rate, RSA
and PEP), incl. HPA-axis responsivity (cortisol). All selected measures are
developed for young children and administered by an experimenter trained in
assessments with young children. The duration of the study is different for the
different research groups. All two groups will participate in the first two
assessments at T0, . A second assessment is scheduled for the SM group, in
order to measure changes in functioning, arousal, stressresponsivness,
cognition and social information processing over time within the SM group
compared to typical development. Children do not directly benefit from
participation but will receive a small present at the end of each assessment.
All parents are offered a short report with individual results of their child.
This report is based on the normed instruments that have been developed for
clinical purposes.
In short, we are convinced that the investment that we ask from the children
and their parents is well balanced. We believe that the time and effort we ask
from children and parents outweight the potential insights that the research
can yield. We expect that all children in the clinical groups will receive
clinical treatment and this is no limitation to study participation.
Wassenaarseweg 52
Leiden 2333 AK
NL
Wassenaarseweg 52
Leiden 2333 AK
NL
Listed location countries
Age
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).
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL69902.058.19 |