The primary objective of this study is to determine the effect of specific communicative abilities (speech recognition in noise; vocal emotion recognition and emotion expression) in children with hearing loss on their psychological (emotional and…
ID
Source
Brief title
Condition
- Hearing disorders
- Communication disorders and disturbances
- Age related factors
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameter/endpoint
Psychosocial difficulties as estimated with the HEAR-QL, and the CBCL, TRF, and
YSR.
Auditory functioning as estimated with pure tone audiometry, speech perception
in quiet measured with the NVA for soft speech, speech intelligibility in
noise, measured with the Digits in Noise test (DIN).
Vocal emotion score as estimated with the EmoHI emotion recognition test, and
with the vocal emotion expression test.
Psychosocial difficulties
HEAR-QL
The Hearing Environments and Reflection on Quality of Life questionnaire is a
valid, reliable and sensitive quality of life assessment tool for children with
hearing loss (35). It is available in two versions, one for children (7-12 yrs)
and one for adolescents (12-18 yrs). The child version consists of 34 questions
divided into the four subscales: hearing loss, environment, activities,
emotions. The total scores can range from 26 to 130, where 26 indicates no
difficulties on any scale and 130 indicates most difficulties on all scales.
The adolescents version contains 36 questions, divided into the four subscales:
listening, social, school, emotions. The total scores can range from 29 to 145,
where 29 indicates no difficulties on any scale and 145 indicates most
difficulties on all scales. The child- and adolescent*s version can be found in
appendix 2a and 2b respectively.
The HEAR-QL is part of the clinical routine, it may be that children have
already filled out the questionnaire. Children that have not filled out the
questionnaire, or their submission is more than six months ago, are required to
fill it in as part of this study. The duration of administration is 10 minutes.
The HEAR-QL will be filled out by the participants. This will be done online,
at home.
The HEAR-QL will serve as the outcome measure for the participants* hearing
related quality of life and coping with social situations.
Child Behavior Checklist (CBCL), Teacher Report Form (TRF), Youth Self Report
(YSR)
The CBCL (36) is a parent report form to screen for emotional, behavioral, and
social problems in children between 6 and 18 years of age. It will serve as the
assessment of the participants* psychosocial difficulties. The CBCL contains a
total of 113 questions in eight different categories: anxious/depressed,
withdrawn/depressed, somatic complaints, social problems, thought problems,
attention problems, rule-breaking behavior, and aggressive behavior. The CBCL
also has a scale set to show scores associated with disorders from the
Diagnostic and Statistical Manual of Mental Disorders (DSM) (37): anxiety,
oppositional defiant disorder, conduct problems, somatic problems, affective
problems, and attention deficit disorder. Many studies have demonstrated a high
rate of reliability between the scales of the CBCL and psychological diagnoses
(38). Teacher and Child versions of the CBCL are also available. Those are the
Teacher Report Form (TRF) and the Youth Self Report (YSR). The Dutch CBCL, YSR
and TRF can be found in appendix 3a, 3b, 3c respectively.
The problem items can be completed by most parents and teachers in about 10
minutes and the competence items in another 5 to 10 minutes. This will be done
online, at home.
The CBCL, YSR, and TRF will serve as outcome measures for the participants*
mental health and psychosocial difficulties. Additionally, the school
performance section in the CBCL and TRF will serve as an indicator of
intelligence.
Audiometry: pure tone/speech/Digits in Noise
Pure tone audiometry
Hearing levels are obtained in a sound-proofed booth. Hearing is measured with
a clinical audiometer. Pure-tone air-conduction thresholds are obtained at
frequencies 0.5, 1, 2, 3, 4, 6, and 8 kHz by an experienced audiometrist.
Thresholds are defined by the intensity level at which the tone was heard in 1
out of 2 ascents, resulting in a true clinical audiogram.
Bone conduction testing is done by placing an oscillator on the mastoid process
and measuring threshold at the same frequencies.
This test is applicable from the age of six. The duration is 15 minutes.
The test is part of the clinical routine, it may be that children have already
been tested. Children that have not been tested as part of the clinical routine
in the prior six months are required to undergo pure tone audiometry for the
purpose of this study.
This test will serve as one of the measures for the participants* auditory
functioning.
Speech audiometry in quiet
To test speech perception in quiet, the clinically used Dutch speech test of
the Dutch Society of Audiology was used (39), which consists of phonetically
balanced monosyllabics (consonant-vowel-consonant). Stimuli are presented at a
comfortable sound level, corresponding to the range of speech levels that
participants perceive in daily life. Speech perception is measured in the best
aided condition, therefore children wear the hearing devices (cochlear implants
or hearing aids) as they would wear in daily life.
This test is applicable from the age of four. The duration is 15 minutes.
This may be part of the clinical routine, though this must be within 6 months
of the questionnaire answering. If not, then the test or the questionnaires
will be administered within that time limit.
This test will serve as one of the measures for the participants* auditory
functioning.
Speech audiometry applied as Digits in Noise (DIN) test
The DIN is a speech-in-noise test where the listener is requested to return the
spoken numbers (digits) that are offered to them along with audible noise (40).
The prerecorded male-spoken speech-signal consists of three consecutive digits
(from zero to nine). The listener*s echoed triplet is rated correct or
incorrect by an experienced audiometrist. In total, 24 digit triplets are
presented for each DIN test. The speech recognition threshold is defined as the
average of the SNRs and is calculated automatically by the computer. This test
is applicable from the age of three years and six months.
The duration is 6 minutes.
This may be part of the clinical routine, though this must be within 6 months
of the questionnaire answering. If not, then the test or the questionnaires
will be administered within that time limit.
This test will serve as one of the measures for the participants* auditory
functioning.
Emotion expression and recognition in speech
Emotion recognition in speech applied as EmoHI test
The EmoHI test is a recently developed tool to estimate the recognition of
emotion in speech by hearing impaired children (32). During the test,
participants are asked to link images of a depicted emotion to audio clips
containing non-existent words or sentences expressed with a certain emotion.
The test is administered to the children in the otorhinolaryngology department.
On a computer screen, three clowns are depicted, each expressing one of the
three emotions: anger, sadness, happiness. Audio clips with the vocal cues are
accompanied with a visual stimulus of a parrot moving its beak, to indicate
that a cue has been given. Participants are asked to touch or click on the
clown of choice, after which either a video of confetti falling, or the parrot
shaking its head is shown, to indicate a correct or wrong answer. The test has
been validated and normdata is available (32).
The EmoHI test is applicable from the age of four.
The average duration of the test is 7 minutes.
The score on the test will serve as an age-adjusted indicator of the child*s
ability to recognize emotion in speech.
Emotion expression in speech
To estimate the participants* ability to express emotion in speech,
participants will be asked to repeat six sentences and simultaneously express a
requested emotion. The test will be administered in the otorhinolaryngology
section of the hospital. A set of standard sentences will be used. The child is
requested to repeat the sentence while expressing either happiness, sadness, or
anger. The expressed sentence is recorded with a microphone. The recordings are
analysed and scored to the degree of adequately expressed emotion.
The test is applicable from the age of four.
The average duration of the test is 5 minutes.
The score on this test will serve as an indicator of the child*s ability to
express emotion in speech.
Speech/language abilities
Children*s Communication Checklist
The Dutch version of the Children*s Communication Checklist (CCC) will be used
to identify social and pragmatic language abilities indicated by parents or
caregivers (33). This questionnaire (with 70 items divided over eight scales)
has been validated with children aged 4 to 16. A general composite of
communication is conventionally obtained by using the scales Speech production,
Syntax, Semantics, Coherence, Inappropriate initiation, Stereotyped
conversation, Use of context, and Nonverbal communication. A copy of the second
version of the Dutch CCC can be found in appendix 4.
On average, it takes 15 minutes to complete the questionnaire.
The score on this questionnaire will serve as an indicator of the child*s
language abilities.
Secondary outcome
Secondary study parameters/endpoints
Gender; age; comorbidity; socio-economic status; degree of hearing loss; age of
onset; experience with a hearing device; type of hearing device; modality of
aided hearing; communication mode (sign language/spoken/combination); type of
schooling. Intelligence estimates based upon existing test results from patient
files and school functioning. Speech/language score as estimated with the
CCC-2.
Background summary
Psychosocial difficulties (e.g. peer problems, depression, anxiety, aggression,
hyperactivity) occur more often in children with hearing loss than in the
general population (1-15). These difficulties in turn can lead to future
behavioral problems, lesser peer acceptance, and lower academic achievement
(16). Previous findings suggest that psychosocial difficulties may be related
to poorer communicative abilities (17). Compared to normal hearing peers,
children with hearing loss exhibit less adequate communication skills, both
hearing related (e.g.; speech perception, especially in challenging listening
environments) and language related (e.g.; pronunciation, vocabulary, and
syntax) (12, 18-20). Also, it is suggested that children with hearing loss
(both with and without cochlear implants or hearing aids) are likely to make
less use of the psycho-emotional elements of communication, such as
interpreting intonation (21-25). Hearing-impaired children therefore may be
more likely to become isolated from their social environment, which is
supported by studies observing lesser bonding and attachment (14).
Several communicative domains have not been investigated before. Therefore, we
intend to investigate what specific communicative domains are related to
psychosocial difficulties and how these domains relate to one another. We
intend to compose a multivariate model to determine the individual effect of
communicative factors (e.g.; hearing status, speech recognition, vocal emotion
perception and emotion expression) on psychosocial difficulties, while
identifying confounding variables.
Study objective
The primary objective of this study is to determine the effect of specific
communicative abilities (speech recognition in noise; vocal emotion recognition
and emotion expression) in children with hearing loss on their psychological
(emotional and behavioral problems, quality of life) and social (peer
relationships, social behavior) outcomes.
The secondary objective is to determine the relationship between psychological
and social outcomes in hearing-impaired children and their gender; age;
intelligence; comorbidity; socio-economic status; degree of hearing loss;
speech/language abilities; age of onset of hearing loss; experience (in years)
with a hearing device; type of hearing device; side of aided hearing;
communication mode (sign language/spoken/combination); type of schooling.
Hypothesis: The psychosocial difficulties known to exist among hearing impaired
children is related to the following specific aspects of communication: speech
recognition in complex listening situations, emotion recognition and emotion
production in speech.
Study design
Over the period of March to September 2021 we aim to include at least 113
participants in this study. During this period, a total of ten measures will
be administered. Several of these measures are used in the standard clinical
care, therefore, in a share of the participants, these measures do not have to
be administered in addition.
The following questionnaires will be administered:
HEAR-QL (10 minutes), filled out at home by the child
CBCL (20 minutes), filled out at home by the child, parents, and teacher
CCC-2 (15 minutes), filled out at home by the parents
The following tests will be administered:
pure tone audiometry (15 minutes), performed at the hospital by the child
speech audiometry (15 minutes), performed at the hospital by the child
Digits in Noise test (6 minutes), performed at the hospital by the child
EmoHI test (7 minutes), performed at the hospital by the child
Emotion expression in speech test (5 minutes), performed at the hospital by the
child
The total time burden for the child is 1 hr 18 minutes, for the parents 35
minutes, for the teachers 20 minutes
Study Sites
- Erasmus Medisch Centrum Rotterdam, The Netherlands (Erasmus MC), department
of Otorhinolaryngology, Head and Neck Surgery.
- Universitair Medisch Centrum Groningen, The Netherlands (UMC Groningen),
department of Otorhinolaryngology, Head and Neck Surgery.
Psychosocial difficulties
Psychosocial difficulties will be measured with the Child Behavior Checklist
(CBCL) and the Hearing Environments and Reflections on Quality of Life
questionnaire (HEAR-QL). The parents of the participants will be requested to
fill out the CBCL. Also the CBCL teacher version and child version will be
used. These are the Teacher Report Form (TRF), and the Youth Self Report (YSR),
respectively. The YSR is applicable in children from the age of 11 and onwards.
The HEAR-QL will be filled out by the participants that are 7 years or older.
All questionnaires will be administered through Zorgmonitor in the Erasmus MC
and LimeSurvey in the UMC Groningen. Zorgmonitor is an online platform used to
administer and assess clinical questionnaires, it is used daily by healthcare
professionals in the Erasmus MC. Limesurvey is an application for capturing
clinical research data. This survey software provides a flexible platform and
wide host of tools for developing surveys and survey questions (31).
Hearing status, communicative abilities, and intelligence
Hearing status will be assessed through pure tone audiometry (for children with
hearing aids), speech perception in quiet in best aided condition, and the
Digits in Noise (DIN) test. Emotion perception will be estimated with the EmoHI
test, where the children are asked to select the emotion that the provided
audio sample is expressing (32).
Emotion production will be estimated with an emotion production test, where
children are asked to vocally express a requested emotion while repeating a set
of standard sentences.
Language abilities will be estimated with the Children*s Communication
Checklist (33), to be filled out by the parents or caregivers.
Intelligence will be estimated with the *school functioning* section in the TRF
and CBCL, and additionally using the results of intelligence measures recorded
in the participants* clinical files.
Several tests are implemented in the standard clinical care of the patients.
This study requires recent test scores, therefore, it may be possible that
participants are required to be tested again outside the standard clinical
care. The measurements regarding this are the HEAR-QL, pure tone audiometry,
speech audiometry, and the DIN.
Study burden and risks
Benefits
Examining the psychosocial difficulties and -development may assist children
and parents in forming realistic expectations of their child*s development, and
it will help them to understand the behavior of the child. Additionally,
relevant discoveries will allow the parents to decide earlier on intervening.
Participants eligible for inclusion are all children with hearing loss that
have been using a hearing aid or Cochlear Implant for at least one year.
Because the project aims to investigate the psychosocial difficulties of
children with hearing loss, there is no other population that could be eligible
for inclusion. Therefore the research may be regarded as group-related.
Risks
The right not to know is a medical-ethical right that should be taken into
account when applying new measures for investigation.
Children may be flagged as being psychosocially divergent. This may result in
stigma, psychiatric diagnoses, and the ensued burden of therapy, that otherwise
may never have occurred. Therefore we offer the possibility to not reveal the
test results to the participants and/or their parents.
There are no risks involved in participating in the study.
Dr.Molewaterplein 40
ROTTERDAM 3015GD
NL
Dr.Molewaterplein 40
ROTTERDAM 3015GD
NL
Listed location countries
Age
Inclusion criteria
1. Children between 6 and 18 years of age with hearing loss;
2. Children that have been using a hearing aid or cochlear implant for at least
one year;
1A. Children with normal hearing between 13 and 18 years of age
Exclusion criteria
1. Refusal to participate;
2. Severe cognitive or physical impairment in the children that leads to the
inability of participating in all tests and inability of filling out the
questionnaires administered in this study;
3. Inadequacy in the Dutch language that leads to the inability of
participating in the tests and questionnaires;
4. Illiteracy of the parents that leads to the inability to answer the
questionnaires.
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 | NL76699.078.21 |