Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05854719 |
| Other study ID # |
47/2022 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 12, 2023 |
| Est. completion date |
December 31, 2024 |
Study information
| Verified date |
May 2023 |
| Source |
University of Oulu |
| Contact |
Kerttu Huttunen, PhD |
| Phone |
+358504776610 |
| Email |
kerttu.huttunen[@]oulu.fi |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The goal of this clinical trial is to find out the role of background factors and gaze use in
children's speechreading performance.
The main questions it aims to answer are:
- Which background factors and eye gaze patterns are associated with the best
speechreading results in hearing children and those with hearing impairment/loss?
- Are children's gaze patterns and facial expression discrimination associated with
interpretation of emotional contents of verbal messages in speechreading?
- What is the efficacy of intervention that is based on the use of a speechreading
application to be developed?
Participants will be
- tested with linguistic and cognitive tests and tasks
- tested with a speechreading test and tasks with or without simultaneous eye-tracking
- about half of the participants with hearing impairment/loss will train speechreading
with an application
Researchers will compare the different age groups and the results of hearing children to
those of children with impaired hearing to see if there are differences.
Description:
1. Aim The objectives of this project are to 1) gain information about speechreading
abilities in Finnish of children without and with hearing impairment, 2) obtain
information about the association between gaze behaviour and speechreading accuracy, 3)
develop a test for speechreading for Finnish-speaking children, 4) find out whether
emotion discrimination (discrimination of facial expressions) helps children with
impairment in speechreading, 5) find out whether speechreading can effectively be
trained with a smart device application, and 6) explore and train artificial
intelligence algorithms further with the help of data on children's use of gaze and
speechreading skills (this part does not belong to the clinical trial part of the
study).
2. Study design Controlled, clinical trial. Study arms: 1) hearing children serving as
controls 2) children with impaired hearing participating in speechreading training, 3)
children with impaired hearing serving as controls
Altogether 140 children (half of them with impaired hearing) will be tested remotely
(via Zoom application), and 100 children on site (as eye-tracking is used in data
collection from them).
Caregivers will be requested to fill out a background form by using an on-line survey
platform REDCap having a high data protection capability. Caregivers will give
information about their child's hearing ability/level based on the most recent
audiogram, overall health (e.g., possible medical diagnoses, vision) and development.
Caregivers' profession and educational level will also be surveyed.
Child outcomes:
Children will be tested with linguistic, cognitive and social cognitive tests and tasks
and 100 children also with eye-tracking.
Of the linguistic tests and tasks, a validated Finnish version (Laine et al., 1997) of
the Boston Naming Test (Kaplan et al., 1983) is used in testing child's expressive
vocabulary. In the nonword repetition subtest of the Nepsy Test (Korkman, 1998), the
child is asked to repeat 16 nonwords presented as an audio recording. The phonological
processing subtest of the NEPSY II Test (Kemp & Korkman, 2008) is composed of two
phonological processing tasks designed to assess phonemic awareness. It explores
identification of words from word segments. Children aged 7 to 8 years are asked to
repeat a word and then to show from pictures the alternative in question when the test
administrator has first pronounced only a part of the word as a cue. Children aged 9 to
11 years are asked to create a new word by omitting a part of a compound word or a
phoneme with the test administrator first pronouncing the part to be omitted. Reading
skills of the children is explored with three subtests, Technical reading ability TL2B,
TL3B and TL4B, of the ALLU Test (Lindeman, 1998). The child is asked to select the right
alternative out of four line drawings to match it with single words or sentences or the
judge whether the meaning of the sentence written is true or false.
Children's speechreading skills will be assessed with Children's speechreading test
(Huttunen & Saalasti) which contains single words and short sentences and a task in
which facial expressions and speechreading on sentence level need to be combined.
Firstly, a novel computerized Children's speechreading test will be constructed
(Huttunen & Saalasti) for children acquiring Finnish. In addition to piloting results of
hearing children aged 8 to 11 years, information about the receptive vocabulary of
8-11-year-old children with hearing impairment, and visual analogues of spoken phonemes
(visemes) in Finnish will be used as the central basis for choosing the items for the
multiple-choice word-level part of the test. Two- to three-word sentences will be
included in the sentence-level part of the test.
When giving their responses in the Children's speechreading test, after watching each
video clip, children need to discriminate the word or sentence expressed by choosing
from alternatives given as drawings and illustrating various persons, objects, or
events. For validating the novel speechreading test, that is, to obtain the age norms
for it and to explore its psychometric properties, 120 children with normal hearing and
typical development (30 children per age group) and 120 children with HI (again, 30
children per age group) will be tested with it. Reading level sufficient for selecting
the alternatives for the meaning of short sentences in the sentence-level part of the
speechreading test is required from the participants.
In addition to the Children's speechreading test, an emotion + speecreading task is
conceived to see whether children can make use of additional information from facial
expressions to discriminate the sentences they speechread. For that, a speaker expresses
some classic basic emotions (happiness, sadness, anger) in 10 sets of four sentences to
be constructed for this purpose. Ten video recordings are presented without voice to the
children with always four written alternative choices.
Children will also be tested with cognitive and social cognitive tests and tasks:
reaction time (Reaction time task), first-order Theory of Mind (Sally Anne Test),
second-order Theory of Mind skills (modified Ice Cream Van Task), auditory short-term
memory (ITPA auditory serial memory subtest), visual short-term memory (ITPA visual
serial memory subtest), visuo-spatial short-term memory (Corsi Block Test), emotion
discrimination (discrimination of facial expressions from photographs, video clips and
the FEFA 2 test).
Of the cognitive and social cognitive tests and tasks, the Reaction time task which
follows the classic principles of a two-choice reaction time test, two numbers randomly
appear on a computer screen; within 1 to 3 seconds either on the left or on the right
side of the screen. Child's task is to strike the left or right arrow key on the
keyboard as soon as the the number has appeared on the screen. The task takes less than
two minutes to perform, and after 40 numbers shown the software produces the results
(mean reaction time in milliseconds, SD, min, max and the number of correct answers as a
relative percentage score).
As the first-order Theory of Mind task, the classic Sally Anne Test (Baron-Cohen, Leslie
& Frith, 1985) will be used and as the second-order Theory of Mind skills a modified
version of the Ice Cream Van Task (Perner & Wimmer, 1985; Doherty, 2009). In the
second-order task, four drawings constructed are used to help the child to understand
and to remember the story told by the task administrator.
Short term memory skills are assessed using the auditory and visual short-term
sequential memory subtests of the validated Finnish version (Kuusinen & Blåfield, 1974)
of the Illinois Test of Psycholinguistic Abilities (ITPA) (Kirk et al., 1968). In the
auditory short-term subtest of ITPA the child is asked to orally repeat digit series
given and in the visual short-term subtest to arrange the right symbols in the right
order. In the visual short-term subtest, the test administrator first shows the symbol
series and the child restores that in the short-term memory to reproduce the series.
Visuo-spatial short-term memory is researched by using the Corsi Block Test (Corsi,
1972, Kessels, van Zandvoort, Postman, Kapelle & de Hand, 2000) included in the
PsyToolkit (Professor Gijsbert Stoet). In the on-line test, nine blocks are shown. They
are arranged in certain fixed positions on a screen in front of the participant. The
software flashes a sequence of blocks, for example, a sequence of three different
blocks, one after another. As a response, by using a mouse, the participant needs to tap
the blocks on the screen in the same order the on-line test showed. The test takes less
than 30 seconds to perform. The Corsi span is defined as the longest sequence a
participant can correctly repeat.
Discrimination of facial expressions from photographs and video clips are
self-constructed tasks (Huttunen, 2015, first described in Huttunen, Kosonen, Laakso &
Waaramaa, 2018). In the first computerized task, a set of 12 photographs depicting four
different emotions (three basic emotions and a neutral expression) are shown. Four
verbal labels are given as written response choices. To test facial emotion recognition
skills using dynamic input, the same set of emotions expressed by the same persons are
presented as video clips of two seconds each with four verbal labels as response
choices.
The computerized "Faces" submodule of the Finnish version of the FEFA 2 test (The
Frankfurt Test and Training of Facial Affect Recognition; Bölte et al., 2013; Bölte &
Poustka, 2003) is used as a standardized task to assess children's facial emotion
recognition skills. This test consists of 50 photographs depicting seven different
emotions and their labels as response choices (joy, anger, sadness, fear, surprise,
disgust and neutral). The child selects the alternative to match the facial expression
(emotion) presented. The FEFA 2 software summarizes the results (total score, confusion
matrices, response time).
Children's gaze use will be explored by eye-tracking (EyeLink 1000+ device) during
facial expression and speechreading tests and tasks. Eye-tracking is used for 100
children (50 with normal hearing and 50 with hearing impairment/loss). Their gaze use is
explored during Children's speechreading test, during the tasks in which facial
expressions need to be discriminated from photographs and video clips, and during the
emotions + speechreading task. Chin rest is used to stabilize the position of the child
for securing the success in data collection. Fixations, dwell time (the time the gaze
stays on certain place on the screen) and gaze path are analysed to find out which areas
of interest on the face are the ones that attract the children's gaze the most. It is
explored with eye tracking data what kind of gaze use and gaze patterns are optimal for
children's speechreading and emotion discrimination performance.
3. Sample size Hearing children (n = 120) aged 8 to 11 years (30 children per age group),
Children with hearing impairment (n = 120) aged 8 to 11 years (30 children per age
group).
4. Blinding and randomization None
5. Follow-up protocols
Altogether 100 children with impaired hearing out of the aimed total of 120 will be tested
twice:
1. After initial testing, 50 children with impaired hearing will be asked to train
speechreading with a smart device application at home. After two months their emotion
discrimination and speechreading skills and gaze use during emotion discrimination and
speechreading tasks will be examined again (on-site testing). Their use of speechreading
application will be explored by transferring the user data (how much they have used the
application and how their speechreading skills have developed as indicated by the
scoring system built in the software) with a cable or blue-tooth connection.
2. A group of children with impaired hearing (n = 50) will serve as controls; they will be
remotely tested (via Zoom application) after two months of the initial testing with no
intervention between the initial and last assessment.
