Our primary objective is to assess the relation between itch and sustained attention in 7-11 year old children with atopic dermatitis (AD). Secondary objectives are to assess the relation between itch and task-oriented behavior, to assess whether…
ID
Source
Brief title
Condition
- Epidermal and dermal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome is sustained attention measured with the Amsterdamse
Neuropsychologische Taken (ANT) Sustained Attention Dots subtest.
Secondary outcome
Secondary outcomes are observations of task-oriented behavior and itch-related
behavior (e.g. scratching), tests of interoceptive accuracy, interoceptive
awareness, cutaneous sensibility, and thermal (cold and warm) and vibration
detection thresholds, questionnaires on sensory processing modulation,
emotional and behavioral problems, quality of life, and itch, and physician
reported AD severity.
Background summary
Atopic dermatitis (AD) is a common inflammatory skin disorder that affects up
to 20% of children in high-income countries. AD has many know psychological
comorbidities including depression, anxiety, attention-deficit/hyperactivity
disorder (ADHD), and autism spectrum disorders (ASD). Furthermore, children
report that due to AD flares, their concentration at school is affected 7-10%
of the time. The relation between AD and ADHD and ASD, in which concentration
may play a role, is poorly understood
There is much debate whether ADHD and ASD can be regarded as distinct disorders
since evidence accumulates that there is a shared etiology, biology, and
phenotype for both conditions. Both conditions are characterized by
interrelated problems with sensory processing, sleep, attention, and
interoception. A similar pattern of problems emerges in children with AD,
although literature is sparse. Investigation of the interrelation among
attention, sensory processing, interoception and sensibility in children with
AD may shed light on the mechanisms behind the prevalence of ADHD and ASD in
this group of children. Furthermore, we focus on the relation between AD
severity and attention, as this hinders children in their school performance
and may therefor impede future perspectives. A better understanding of sensory
and interoceptive abilities could also directly benefit clinical practice, as
adequate AD treatment is dependent on patient* own assessment of symptom
severity which seems impaired in some patients.
Study objective
Our primary objective is to assess the relation between itch and sustained
attention in 7-11 year old children with atopic dermatitis (AD). Secondary
objectives are to assess the relation between itch and task-oriented behavior,
to assess whether itch-related behavior (e.g. scratching) differs between
task-oriented and task-free situations, and to explore levels of interoceptive
accuracy, interoceptive awareness, cutaneous sensibility, thermal (cold and
warm) and vibration detection thresholds, and sensory processing modulation and
whether these are related to AD severity and emotional and behavioral problems
in children with AD.
Study design
A cross-sectional, observational design. Children will have one visit to the
outpatient clinic of the Erasmus MC.
Study burden and risks
The study consists of 1 visit to the outpatient dermatology clinic of Erasmus
MC. Children will participate in 2 neuropsychological tests, 2 interoception
tests, and 4 quantitative sensory test. During the neuropsychological tests
children*s task-oriented and scratching behavior is video-recorded and whilst
the child is in the waiting room a video-recording of scratching behavior is
made. In addition, they will complete 3 numeric rating scales and 1
questionnaire. Children will participate in a standard dermatological
assessment (5 minutes). Parents will complete 7 questionnaires, of which 4 have
10 questions or less. The neuropsychological and quantitative sensory testing
are used in neuropsychological and neurological regular care. The interception
tests are especially developed for young children. These tests take time, but
usually children enjoy these test and the attention from the investigator.
Without motivation from the child the test results are less reliable, therefore
the test are made as pleasant as possible. Questionnaires for the children
themselves and the dermatological assessment are limited in time as much as
possible, to minimalize burden. Parents are asked to complete questionnaires
about their child*s functioning, which costs time but the questionnaires do not
contain confronting topics. There are no risks related to participating in this
study.
Participating children and parents will not benefit directly from this
study, although the results of the sustained attention test and dermatological
assessment will be discussed with child and parents. In general, children with
AD will eventually benefit from this study as results may shed light on the
relation between itch and concentration, which could aid children in their
school performance. Furthermore, it may also help to unravel why certain
children with AD find it difficult to assess their eczema severity, which is
necessary for adequate treatment. As a more distant outcome, results may help
unravel the mechanism behind the high prevalence of ADHD and autism among
children with AD.
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
Inclusion criteria
- Children aged 7 to 11 years, with atopic dermatitis (AD diagnosed according
to the UK working party criteria)
- Child and parent(s)/legal guardian(s) having sufficient comprehension of the
Dutch language to understand study materials
- Children and parents/guardians able to participate in the study and willing
to give
written informed consent
Exclusion criteria
- Children under the age of 7 or above the age of 11 years
- Children with large burn scars or other large scars
- Children with chicken-pox or other infections that cause skin itch or pain
- Children with itch without visible dermatological abnormalities (pruritus
sine materia, e.g.renal failure (acute, chronic), hyperthyroidism, Hodgkin
disease)
- Children with genetic syndromes known to affect cognitive performance
- Children with an IQ estimated <55 (moderate to severe intellectual disability)
- Prematurity <37 weeks of gestation
- Low birth weight (<2.5 SD for gestational age)
- Application of ointments including topical corticosteroids at the day of the
assessments
- Children who have used sedating antihistamines within 5 times the half-life
of the specific drug
- Children who use methylphenidate or other medication that could affect
neuropsychological functioning within 5 times the half-life of the specific
drug
Design
Recruitment
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 | NL83551.078.22 |