<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03778632</url>
  </required_header>
  <id_info>
    <org_study_id>16/621-15</org_study_id>
    <nct_id>NCT03778632</nct_id>
  </id_info>
  <brief_title>Intensive Stuttering Group Therapy for School-age Children and the Effect of Emotional Reactivity on Therapy Outcomes</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hacettepe University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hacettepe University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objectives of this investigation were two-fold: 1) to investigate whether&#xD;
      implementation of individualized desensitization exercises in an intensive stuttering group&#xD;
      therapy for school-age children who stutter is superior to the standard application of&#xD;
      intensive stuttering group therapy, 2) to examine the relationship between exhibited&#xD;
      emotional reactivity (positive and negative affect) and stuttering recovery rates. Secondary&#xD;
      objectives included: 1) investigating whether cognitive, affective, linguistic and social&#xD;
      scores differ with treatment and, 2) heart rate and skin conductance changes associated with&#xD;
      the stuttered utterance during intensive stuttering group therapy activities.&#xD;
&#xD;
      Twelve children (8 to 12 years of age, with equal randomization [1:1]) randomized to two&#xD;
      groups; 1) Study group, individualized desensitization exercises implemented in 2 weeks of&#xD;
      intensive stuttering group therapy(n=6), 2) Control group, 2 weeks of standard intensive&#xD;
      stuttering group therapy(n=6). Children were blinded to treatment arm. The first part of this&#xD;
      study was a superiority trial of individualized desensitization exercises in intensive&#xD;
      stuttering group therapy. The second part of the study was conducted with the study group&#xD;
      during the daily therapy activities of intensive stuttering group therapy to investigate the&#xD;
      emotion's effect on therapy outcomes with behavioral and physiological measures.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators hypothesized that (1) implementation of the usage of individualized&#xD;
      desensitization exercises in an intensive stuttering group therapy created more effective&#xD;
      treatment results than standard implementation of the desensitization exercises in an&#xD;
      intensive stuttering group therapy in school-age children who stutter, (2) recovery rates&#xD;
      will differ according to exhibited affects before stuttered utterances, (3) heart rate and&#xD;
      skin conductivity findings before, during and after the stuttered utterances will differ from&#xD;
      the general findings.&#xD;
&#xD;
      Children (n=12) were recruited and randomized in a 1:1 ratio either Control group (n=6) or&#xD;
      Study group (n=6) by the study assistant. Randomization was stratified by sex, using a block&#xD;
      size of two. For the first part of the study 6 study assessors (speech and language therapy&#xD;
      interns who were experienced in the assessment procedure) who were not otherwise involved in&#xD;
      the study, were participated in baseline and follow-up assessments. Children were blinded to&#xD;
      treatment arm. Video recordings of assessments of the Turkish version of Stuttering Severity&#xD;
      Scale-4 were made. Offline assessments of the stuttering severity were done by two research&#xD;
      assistants. One of the research assistants was blinded to group assignment and was not&#xD;
      otherwise involved in the studies. Video recordings of assessments were labeled by decimal&#xD;
      numbers randomly. The masking of the data was done by the study assistant. The second part of&#xD;
      the investigation conducted with children in the study group.&#xD;
&#xD;
      For the first part of the study, intervention and family training was applied by a&#xD;
      professional therapist who has 7 years of experience in stuttering therapy. When children&#xD;
      applied for the baseline assessments, parent training was applied. Training included; (a)&#xD;
      general information on stuttering, (b) underlying facts, and (c) how to communicate with&#xD;
      their children. At the training session, parents were given an information brochure for&#xD;
      teachers of their child. Family training was conducted a month before intensive stuttering&#xD;
      group therapy.&#xD;
&#xD;
      The intervention used a hybrid approach which was combined with the evidence-based&#xD;
      techniques: speech reconstruction includes fluency shaping and stuttering modification;&#xD;
      cognitive restructuring; emotional restructuring; desensitization; video self-modeling.&#xD;
&#xD;
      Standard therapy application included 7 components:&#xD;
&#xD;
        1. Recognition: Speech mechanism, stuttering, fluency or stuttering modification technic,&#xD;
           emotions, thoughts, bodily actions, behaviors etc. What is it? Where/When/How to use?&#xD;
           Transferring the rationale of the exercise to the participants.&#xD;
&#xD;
        2. Desensitization: It is the process of gradually exposing the participants to the&#xD;
           stuttering induced situations (in which there is a negative and very positive mood) by&#xD;
           first determining the stuttering induced situations (anxiety ladder exercise used, to&#xD;
           begin with). Problem-solving exercises and role-model exercises applied.&#xD;
&#xD;
        3. Technic usage:&#xD;
&#xD;
             1. Video-model had prepared for fluency shaping which includes easy start, light&#xD;
                articulatory contacts, connection, and pausing techniques. At first video model had&#xD;
                been watched for once; than clinician asked the children to identify the speech&#xD;
                characteristics and they watched the video-model again, chorus readings were done&#xD;
                altogether with the clinician and the group, clinician's help retracted gradually&#xD;
                and children read the passages alone.&#xD;
&#xD;
             2. To generalize the fluency technique into speech gradual increase method was used;&#xD;
                one-word production games, two-word production games, sentence production games,&#xD;
                conversation activities, reading aloud activities, role-model activities were used.&#xD;
&#xD;
             3. For stuttering modification pull-out technique was introduced during daily&#xD;
                activities.&#xD;
&#xD;
        4. Diversified Technic Usage: The skills learned have been used in complex tasks. For&#xD;
           example; Making presentations in front of the group and answering questions.&#xD;
&#xD;
        5. Problem-Solving Skills: Identifying problem situations, tagging the emotions,&#xD;
           brainstorming, decision making, role-modeling.&#xD;
&#xD;
        6. Generalization: In order to generalize the learned skills to the daily activities,&#xD;
           outside of the therapy room, orienteering activity was organized with the adults they&#xD;
           hadn't met before. Each child completed a set of tasks outside of the therapy room.&#xD;
           Presentation in front of a group of adults (their parents) was organized.&#xD;
&#xD;
        7. Maintenance: In order to maintain the skills gained in therapy after therapy, video&#xD;
           self-modeling technique was used. On the last day of therapy, each subject was visually&#xD;
           fluent during free speech and reading tasks and was asked to watch these videos every&#xD;
           day after therapy.&#xD;
&#xD;
      For both groups of children, desensitization exercises were conducted. Standard intensive&#xD;
      stuttering group therapy was applied to the control group while in the study group,&#xD;
      clinician's observation was included in the intervention process. Predetermined stuttering&#xD;
      inducing situation's table was prepared for each participant. The scenario table was included&#xD;
      5 situations. Clinician observed the children and marked the situations which increased their&#xD;
      stuttering. Mostly marked situations were identified for each child. At the end of the&#xD;
      first-week children were given instructions for the second week of the therapy. For example;&#xD;
      if the child's stuttering severity increased during reading aloud in front of the group, the&#xD;
      intensity of the reading-aloud in front of the group exercises was increased for him/her.&#xD;
      They were informed that all of them would have special tasks.&#xD;
&#xD;
      Stuttering severity and cognitive, affective, linguistic and social score measures were done&#xD;
      5 times; 1) one month before the therapy, 2) on the first day of the therapy, 3) on the last&#xD;
      day of the therapy, 4) one month after the therapy, and 5) three months after the therapy.&#xD;
&#xD;
      For the second part of the study, the images required for the Emotion Facial Action Coding&#xD;
      System analysis were recorded during the therapy through CH_TECH SONY CHIPSET 2 MEGAPIXEL IP&#xD;
      cameras. A total of six cameras were placed in the therapy room. The analysis of the facial&#xD;
      action coding system was carried out by a certified researcher. Increased stuttering moments&#xD;
      of subjects in the study group were detected by monitoring and transcription of the camera&#xD;
      and microphone recordings at the end of the day. During the time before the fluency technique&#xD;
      was thought to the subjects, 10 stuttering moments were identified and the 5-second window&#xD;
      before the moment of stuttering was coded.&#xD;
&#xD;
      The evaluations were classified in 2 groups, positive or negative affect. Facial expressions&#xD;
      which are expressions specified as non-encoded in Emotion Facial Action Coding System are&#xD;
      identified as neutral facial expressions. Positive affect codings were done via observation&#xD;
      of facial expressions; AU 12 (extraction of the lip corner) and AU 6 +12 (cheek up with the&#xD;
      extraction of the lip corner). Positive affect may be accompanied by AU1 + 2 (eyebrow&#xD;
      elevation), AU25 (mouth opening) or AU 26 (loosening of the jaw) (33). If AU12 occurs without&#xD;
      AU6, AU12 should occur at least C severity in the intensity classification from 5 to Likert&#xD;
      type A to E If AU12 is present with AU6, the intensity of AU12 is B 109, 139. For the coding&#xD;
      of negative affects; AU 9 (nose creasing); AU 10 (upper lip elevation); AU 14 (pitting); AU&#xD;
      15 (depression of the lip corner); It is necessary that at least one of the codes AU 20 (lips&#xD;
      stretching) and AU 1 + 4 (lifting the eyebrows to the midline and approaching) occur at&#xD;
      intensity B.&#xD;
&#xD;
      Skin conductivity and heart rate recordings of participants in the study group were obtained&#xD;
      via E4 wristbands. The wristbands were tested on both wrists during the therapy of the&#xD;
      control group. As the non-dominant hand wrist's recordings resulted with lower noise levels,&#xD;
      the wristbands were worn on the non-dominant side. For the analysis of skin conductivity; 1)&#xD;
      online version of EDA-Explorer, 2) Ledalab and 3) Matlab was used. For the heart rate&#xD;
      analysis, Matlab was used.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 25, 2016</start_date>
  <completion_date type="Actual">June 20, 2018</completion_date>
  <primary_completion_date type="Actual">May 2, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The stuttering severity</measure>
    <time_frame>One month before therapy to three months after therapy</time_frame>
    <description>Comparison of control group and study group by Turkish version of Stuttering Severity Instrument-4 score change.Stuttering Severity Instrument-4 is an instrument that measures stuttering severity of children in the age range of 6 to16 years. This instrument measures stuttering severity by 3 sub-items; 1)frequency, 2)duration, and 3)physical concominants. evaluates speech naturalness of the children's speech. Lowest available score on this instrument is 6 and is equivalent to very mild stuttering and 36&amp; higher points are equivalent to very severe stuttering.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Emotional reactivity (positive and negative affect) effect on therapy outcome</measure>
    <time_frame>Collected during first 3 days of the intensive stuttering group therapy to compare the therapy outcomes</time_frame>
    <description>Obtained by means coding behavioral analysis of positive and negative affect. Emotion facial action coding was used to code positive and negative affects. Positive affect coded when the following action units(AU) appeared; 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 jaw). 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. For the acceptance of affect as negative; 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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in cognitive, affective, linguistic and social scores</measure>
    <time_frame>One month before therapy to three months after therapy</time_frame>
    <description>Cognitive, Affective, Linguistic, Motor and Social Rating Scale for School children who stutter is a tool to assess 5 components; 1) cognitive, 2) affective, 3) linguistic, 4) motor, and 5) social. Cognitive component assess the child's awareness, knowledge understanding of stuttering. The affective component gives information on the child's feelings/attitudes related to stuttering &amp; positive/negative attributes of him/her self. The linguistic component assess: overall language, speech sound &amp; vocabulary abilities and, stuttering with regards to the length and complexity of utterances. The social component assess the child's approach to the social situations. At the end every component was rated on a scale of 1-5 (1= low concern, 5= high concern).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart rate changes</measure>
    <time_frame>Collected during first 3 days of the intensive stuttering group therapy</time_frame>
    <description>Obtained via wearable technology. The average of general heart rate values which were expressed in beat per minute was compared with the average heart rate values occurred in one-minute window before and after the stuttered utterances.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Skin conductance changes</measure>
    <time_frame>Collected during first 3 days of the intensive stuttering group therapy</time_frame>
    <description>Obtained via wearable technology. The average general of skin conductivity values which were expressed in microsiemens was compared with the average skin conductivity values occurred in one-minute window before and after the stuttered utterances.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">11</enrollment>
  <condition>Stuttering, Childhood</condition>
  <condition>Emotion, Expressed</condition>
  <arm_group>
    <arm_group_label>Study Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intensive stuttering group therapy which was included individualized desensitization exercises was applied with the study group. Family training was applied with the parents a month before the therapy. Ten days (4.5 hours a day, a total of 45 hours therapy) of intensive stuttering group therapy was applied.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Standard intensive stuttering group therapy was applied with the control group. Family training was applied with the parents a month before the therapy. Ten days (4.5 hours a day, a total of 45 hours therapy) of intensive stuttering group therapy was applied.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>individualized desensitization exercises</intervention_name>
    <description>implementing individualized desensitization exercises in standard application of intensive stuttering group therapy for school-age children who stutter</description>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_label>Study Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  very mild to moderate stuttering based on Stuttering Severity Instrument-4-Turkish&#xD;
             Version&#xD;
&#xD;
          -  no history of intellectual, emotional, academic, hearing, neurological, physiological&#xD;
             problems based on parental report&#xD;
&#xD;
          -  no history of speech and/or language problems other than stuttering&#xD;
&#xD;
          -  not to be received stuttering therapy during the previous six months.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mavis Emel Kulak Kayikci, Assoc. Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hacettepe University</affiliation>
  </overall_official>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 9, 2018</study_first_submitted>
  <study_first_submitted_qc>December 16, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>December 16, 2018</last_update_submitted>
  <last_update_submitted_qc>December 16, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 19, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hacettepe University</investigator_affiliation>
    <investigator_full_name>Ilkem Kara</investigator_full_name>
    <investigator_title>Research Assistant</investigator_title>
  </responsible_party>
  <keyword>Stuttering</keyword>
  <keyword>School-age</keyword>
  <keyword>Emotional reactivity</keyword>
  <keyword>Wearable technology</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stuttering</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>On request</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03778632
org study id: 16/621-15
nct id: NCT03778632
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: The stuttering severity
time frame: One month before therapy to three months after therapy
description: Comparison of control group and study group by Turkish version of Stuttering Severity Instrument-4 score change.Stuttering Severity Instrument-4 is an instrument that measures stuttering severity of children in the age range of 6 to16 years. This instrument measures stuttering severity by 3 sub-items; 1)frequency, 2)duration, and 3)physical concominants. evaluates speech naturalness of the children's speech. Lowest available score on this instrument is 6 and is equivalent to very mild stuttering and 36& higher points are equivalent to very severe stuttering.
measure: Emotional reactivity (positive and negative affect) effect on therapy outcome
time frame: Collected during first 3 days of the intensive stuttering group therapy to compare the therapy outcomes
description: Obtained by means coding behavioral analysis of positive and negative affect. Emotion facial action coding was used to code positive and negative affects. Positive affect coded when the following action units(AU) appeared; 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 jaw). 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. For the acceptance of affect as negative; 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.
measure: Changes in cognitive, affective, linguistic and social scores
time frame: One month before therapy to three months after therapy
description: Cognitive, Affective, Linguistic, Motor and Social Rating Scale for School children who stutter is a tool to assess 5 components; 1) cognitive, 2) affective, 3) linguistic, 4) motor, and 5) social. Cognitive component assess the child's awareness, knowledge understanding of stuttering. The affective component gives information on the child's feelings/attitudes related to stuttering & positive/negative attributes of him/her self. The linguistic component assess: overall language, speech sound & vocabulary abilities and, stuttering with regards to the length and complexity of utterances. The social component assess the child's approach to the social situations. At the end every component was rated on a scale of 1-5 (1= low concern, 5= high concern).
measure: Heart rate changes
time frame: Collected during first 3 days of the intensive stuttering group therapy
description: Obtained via wearable technology. The average of general heart rate values which were expressed in beat per minute was compared with the average heart rate values occurred in one-minute window before and after the stuttered utterances.
measure: Skin conductance changes
time frame: Collected during first 3 days of the intensive stuttering group therapy
description: Obtained via wearable technology. The average general of skin conductivity values which were expressed in microsiemens was compared with the average skin conductivity values occurred in one-minute window before and after the stuttered utterances.
arm group label: Study Group
arm group type: Experimental
description: Intensive stuttering group therapy which was included individualized desensitization exercises was applied with the study group. Family training was applied with the parents a month before the therapy. Ten days (4.5 hours a day, a total of 45 hours therapy) of intensive stuttering group therapy was applied.
arm group label: Control Group
arm group type: Active Comparator
description: Standard intensive stuttering group therapy was applied with the control group. Family training was applied with the parents a month before the therapy. Ten days (4.5 hours a day, a total of 45 hours therapy) of intensive stuttering group therapy was applied.
intervention type: Behavioral
intervention name: individualized desensitization exercises
description: implementing individualized desensitization exercises in standard application of intensive stuttering group therapy for school-age children who stutter
arm group label: Control Group
arm group label: Study Group
criteria: 
gender: All
minimum age: 8 Years
maximum age: 12 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Mavis Emel Kulak Kayikci, Assoc. Prof.
role: Principal Investigator
affiliation: Hacettepe University
responsible party type: Principal Investigator
investigator affiliation: Hacettepe University
investigator full name: Ilkem Kara
investigator title: Research Assistant
mesh term: Stuttering
sharing ipd: Yes
ipd description: On request
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)