Stuttering, Childhood Clinical Trial
Official title:
Integration of Individualized Variables of School-age Children Who Stutter Into Intensive Stuttering Group Therapy and the Effect of Emotional Reactivity on Therapy Outcomes
The primary objectives of this investigation were two-fold: 1) to investigate whether
implementation of individualized desensitization exercises in an intensive stuttering group
therapy for school-age children who stutter is superior to the standard application of
intensive stuttering group therapy, 2) to examine the relationship between exhibited
emotional reactivity (positive and negative affect) and stuttering recovery rates. Secondary
objectives included: 1) investigating whether cognitive, affective, linguistic and social
scores differ with treatment and, 2) heart rate and skin conductance changes associated with
the stuttered utterance during intensive stuttering group therapy activities.
Twelve children (8 to 12 years of age, with equal randomization [1:1]) randomized to two
groups; 1) Study group, individualized desensitization exercises implemented in 2 weeks of
intensive stuttering group therapy(n=6), 2) Control group, 2 weeks of standard intensive
stuttering group therapy(n=6). Children were blinded to treatment arm. The first part of this
study was a superiority trial of individualized desensitization exercises in intensive
stuttering group therapy. The second part of the study was conducted with the study group
during the daily therapy activities of intensive stuttering group therapy to investigate the
emotion's effect on therapy outcomes with behavioral and physiological measures.
The investigators hypothesized that (1) implementation of the usage of individualized
desensitization exercises in an intensive stuttering group therapy created more effective
treatment results than standard implementation of the desensitization exercises in an
intensive stuttering group therapy in school-age children who stutter, (2) recovery rates
will differ according to exhibited affects before stuttered utterances, (3) heart rate and
skin conductivity findings before, during and after the stuttered utterances will differ from
the general findings.
Children (n=12) were recruited and randomized in a 1:1 ratio either Control group (n=6) or
Study group (n=6) by the study assistant. Randomization was stratified by sex, using a block
size of two. For the first part of the study 6 study assessors (speech and language therapy
interns who were experienced in the assessment procedure) who were not otherwise involved in
the study, were participated in baseline and follow-up assessments. Children were blinded to
treatment arm. Video recordings of assessments of the Turkish version of Stuttering Severity
Scale-4 were made. Offline assessments of the stuttering severity were done by two research
assistants. One of the research assistants was blinded to group assignment and was not
otherwise involved in the studies. Video recordings of assessments were labeled by decimal
numbers randomly. The masking of the data was done by the study assistant. The second part of
the investigation conducted with children in the study group.
For the first part of the study, intervention and family training was applied by a
professional therapist who has 7 years of experience in stuttering therapy. When children
applied for the baseline assessments, parent training was applied. Training included; (a)
general information on stuttering, (b) underlying facts, and (c) how to communicate with
their children. At the training session, parents were given an information brochure for
teachers of their child. Family training was conducted a month before intensive stuttering
group therapy.
The intervention used a hybrid approach which was combined with the evidence-based
techniques: speech reconstruction includes fluency shaping and stuttering modification;
cognitive restructuring; emotional restructuring; desensitization; video self-modeling.
Standard therapy application included 7 components:
1. Recognition: Speech mechanism, stuttering, fluency or stuttering modification technic,
emotions, thoughts, bodily actions, behaviors etc. What is it? Where/When/How to use?
Transferring the rationale of the exercise to the participants.
2. Desensitization: It is the process of gradually exposing the participants to the
stuttering induced situations (in which there is a negative and very positive mood) by
first determining the stuttering induced situations (anxiety ladder exercise used, to
begin with). Problem-solving exercises and role-model exercises applied.
3. Technic usage:
1. Video-model had prepared for fluency shaping which includes easy start, light
articulatory contacts, connection, and pausing techniques. At first video model had
been watched for once; than clinician asked the children to identify the speech
characteristics and they watched the video-model again, chorus readings were done
altogether with the clinician and the group, clinician's help retracted gradually
and children read the passages alone.
2. To generalize the fluency technique into speech gradual increase method was used;
one-word production games, two-word production games, sentence production games,
conversation activities, reading aloud activities, role-model activities were used.
3. For stuttering modification pull-out technique was introduced during daily
activities.
4. Diversified Technic Usage: The skills learned have been used in complex tasks. For
example; Making presentations in front of the group and answering questions.
5. Problem-Solving Skills: Identifying problem situations, tagging the emotions,
brainstorming, decision making, role-modeling.
6. Generalization: In order to generalize the learned skills to the daily activities,
outside of the therapy room, orienteering activity was organized with the adults they
hadn't met before. Each child completed a set of tasks outside of the therapy room.
Presentation in front of a group of adults (their parents) was organized.
7. Maintenance: In order to maintain the skills gained in therapy after therapy, video
self-modeling technique was used. On the last day of therapy, each subject was visually
fluent during free speech and reading tasks and was asked to watch these videos every
day after therapy.
For both groups of children, desensitization exercises were conducted. Standard intensive
stuttering group therapy was applied to the control group while in the study group,
clinician's observation was included in the intervention process. Predetermined stuttering
inducing situation's table was prepared for each participant. The scenario table was included
5 situations. Clinician observed the children and marked the situations which increased their
stuttering. Mostly marked situations were identified for each child. At the end of the
first-week children were given instructions for the second week of the therapy. For example;
if the child's stuttering severity increased during reading aloud in front of the group, the
intensity of the reading-aloud in front of the group exercises was increased for him/her.
They were informed that all of them would have special tasks.
Stuttering severity and cognitive, affective, linguistic and social score measures were done
5 times; 1) one month before the therapy, 2) on the first day of the therapy, 3) on the last
day of the therapy, 4) one month after the therapy, and 5) three months after the therapy.
For the second part of the study, the images required for the Emotion Facial Action Coding
System analysis were recorded during the therapy through CH_TECH SONY CHIPSET 2 MEGAPIXEL IP
cameras. A total of six cameras were placed in the therapy room. The analysis of the facial
action coding system was carried out by a certified researcher. Increased stuttering moments
of subjects in the study group were detected by monitoring and transcription of the camera
and microphone recordings at the end of the day. During the time before the fluency technique
was thought to the subjects, 10 stuttering moments were identified and the 5-second window
before the moment of stuttering was coded.
The evaluations were classified in 2 groups, positive or negative affect. Facial expressions
which are expressions specified as non-encoded in Emotion Facial Action Coding System are
identified as neutral facial expressions. Positive affect codings were done via observation
of facial expressions; AU 12 (extraction of the lip corner) and AU 6 +12 (cheek up with the
extraction of the lip corner). Positive affect may be accompanied by AU1 + 2 (eyebrow
elevation), AU25 (mouth opening) or AU 26 (loosening of the jaw) (33). If AU12 occurs without
AU6, AU12 should occur at least C severity in the intensity classification from 5 to Likert
type A to E If AU12 is present with AU6, the intensity of AU12 is B 109, 139. For the coding
of negative affects; AU 9 (nose creasing); AU 10 (upper lip elevation); AU 14 (pitting); AU
15 (depression of the lip corner); It is necessary that at least one of the codes AU 20 (lips
stretching) and AU 1 + 4 (lifting the eyebrows to the midline and approaching) occur at
intensity B.
Skin conductivity and heart rate recordings of participants in the study group were obtained
via E4 wristbands. The wristbands were tested on both wrists during the therapy of the
control group. As the non-dominant hand wrist's recordings resulted with lower noise levels,
the wristbands were worn on the non-dominant side. For the analysis of skin conductivity; 1)
online version of EDA-Explorer, 2) Ledalab and 3) Matlab was used. For the heart rate
analysis, Matlab was used.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05668923 -
Speech Signals in Stuttering
|
N/A | |
Recruiting |
NCT05908123 -
Exploring the Nature, Assessment and Treatment of Stuttering
|
N/A | |
Recruiting |
NCT05003583 -
Effects of Emotional Processes on Speech Motor Control in Early Childhood Stuttering.
|
N/A | |
Completed |
NCT03160586 -
Stuttering and Anxiety
|
N/A | |
Not yet recruiting |
NCT04412213 -
Correlation of Family History, Age at Onset & Severity of Stuttering
|
||
Recruiting |
NCT05286151 -
Network Connectivity and Temporal Processing in Adolescents Who Stutter
|
N/A | |
Not yet recruiting |
NCT05640440 -
Executive Function Performance in Children Who Stutter
|
||
Recruiting |
NCT04929184 -
Speech Processing in Stuttering
|
N/A | |
Not yet recruiting |
NCT05291572 -
Comparative Study Between Three Different Methods for Stuttering Therapy in Children
|
Phase 4 |