xml: <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/NCT06030583</url>
    </required_header>
    <id_info>
      <org_study_id>HUSLP_ADHD_VOICE</org_study_id>
      <nct_id>NCT06030583</nct_id>
    </id_info>
    <brief_title>The Investigation of Vocal Behaviors in Children With ADHD</brief_title>
    <official_title>An Investigation of Vocal Hygiene, Vocal Behaviors, and Quality of Life Associated With Voice in Children With and Without Attention Deficit Hyperactivity Disorder</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 aim is to gain information about vocal hygiene knowledge level, phonotrauma behavior&#xD;
        frequency, voice-related quality of life, and voice handicap index scores in children&#xD;
        diagnosed with ADHD aged 8 to 11, through inter-group comparisons of scale and questionnaire&#xD;
        data between children diagnosed with ADHD and control group participants aged 8 to 11.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The study will include children aged 8 to 11 with and without a diagnosis of Attention&#xD;
        Deficit Hyperactivity Disorder (ADHD). The study and control groups have been determined with&#xD;
        age and gender matching.&#xD;
  &#xD;
        Within the scope of the study, a comparison between groups will be conducted through the&#xD;
        scores of the Vocal Hygiene Awareness form, Pediatric Phonotrauma Assessment Questions for&#xD;
        Parents, Voice Related Quality of Life Survey, and the Teacher-Reported Pediatric Voice&#xD;
        Handicap Index to examine whether there are any differences between the groups. The Vocal&#xD;
        Hygiene Awareness form will be completed by the child. The Pediatric Phonotrauma Assessment&#xD;
        Questions for Parents, Voice Related Quality of Life Survey, and the Pediatric Voice Handicap&#xD;
        Index will be completed by the parents. The Teacher-Reported Pediatric Voice Handicap Index&#xD;
        will be filled out by the child's teacher.&#xD;
  &#xD;
        The number of participants to be included in the study has been calculated using G Power 3.1&#xD;
        program. Based on an analysis with a power of 0.80 and α (type 1 error) = 0.05 using an&#xD;
        independent t-test, 42 participants for each group, totaling 84 participants, are planned to&#xD;
        be included in the study. Data analysis will be carried out using IBM SPSS Statistics 23&#xD;
        program. Firstly, the normal distribution of ordinal variables will be tested. If the&#xD;
        assumption of normality is met, parametric tests will be used; otherwise, non-parametric&#xD;
        tests will be employed. A statistical significance value of p &lt; 0.05 will be considered.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 31, 2023</start_date>
    <completion_date type="Anticipated">November 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">November 30, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Cross-Sectional</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Inter-group Differences Associated with Phonotraumatic Behaviors</measure>
      <time_frame>The process of collecting data from participants once takes approximately 30 minutes</time_frame>
      <description>Scores Obtained from Pediatric Phonotrauma Assessment Questions for Parents</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Inter-group Differences Associated with Vocal Hygiene Knowledge</measure>
      <time_frame>The process of collecting data from participants once takes approximately 30 minutes</time_frame>
      <description>Scores Obtained from Questions on Vocal Hygiene Awareness</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Inter-group Differences Associated with Voice Related Quality of Life Survey</measure>
      <time_frame>The process of collecting data from participants once takes approximately 30 minutes</time_frame>
      <description>Scores Obtained from the Voice Related Quality of Life Survey</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Inter-group Differences Associated with the Teacher-Reported Pediatric Voice Handicap Index</measure>
      <time_frame>The process of collecting data from participants once takes approximately 30 minutes</time_frame>
      <description>Scores Obtained from the Teacher-Reported Pediatric Voice Handicap Index</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">84</enrollment>
    <condition>Voice Disorders in Children</condition>
    <condition>Voice</condition>
    <arm_group>
      <arm_group_label>Study Group</arm_group_label>
      <description>The research group comprises children aged 8 to 11 diagnosed with Attention Deficit Hyperactivity Disorder.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control Group</arm_group_label>
      <description>The control group consists of children aged 8 to 11 who do not have a diagnosis of ADHD, matched in terms of age and gender with the research group.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Scales and Forms</intervention_name>
      <description>This study does not involve any interventions. Information will be collected from the study group and the control group through scales and forms.</description>
      <arm_group_label>Control Group</arm_group_label>
      <arm_group_label>Study Group</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          The study group participants will be comprised of children aged 8 to 11 who have been&#xD;
          diagnosed with ADHD in the Department of Child and Adolescent Psychiatry at Hacettepe&#xD;
          University. Their inclusion in the study will be based on voluntary participation. For the&#xD;
          control group, participants will be reached through the snowball sampling method, with age&#xD;
          and gender matching, and their inclusion in the study will also be based on voluntary&#xD;
          participation.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  For study group&#xD;
  &#xD;
                 -  Having been diagnosed with ADHD according to DSM-5 (The Diagnostic and&#xD;
                    Statistical Manual of Mental Disorders, Fifth Edition) diagnostic criteria&#xD;
  &#xD;
                 -  Being in the age range of 8-11&#xD;
  &#xD;
                 -  Having Turkish as the native language&#xD;
  &#xD;
                 -  To have a score below the cut-off score (&lt;13) on the Turkish Pediatric Voice&#xD;
                    Handicap Index.&#xD;
  &#xD;
          For the control group:&#xD;
  &#xD;
            -  Not having any psychiatric diagnosis&#xD;
  &#xD;
            -  Being in the age range of 8-11&#xD;
  &#xD;
            -  Having Turkish as the native language&#xD;
  &#xD;
            -  To have a score below the cut-off score (&lt;13) on the Turkish Pediatric Voice Handicap&#xD;
               Index.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  For the research group;&#xD;
  &#xD;
                 -  Having any history of upper respiratory tract infection in the period up to two&#xD;
                    weeks before the data collection date (one of the questionnaire requests&#xD;
                    considering the last two-week period as a reference).&#xD;
  &#xD;
                 -  Having any known neurological, systemic, or endocrinological diseases affecting&#xD;
                    the voice.&#xD;
  &#xD;
                 -  Having undergone vocal surgery or received voice therapy.&#xD;
  &#xD;
                 -  Having a diagnosis of current hearing loss.&#xD;
  &#xD;
                 -  Having comorbid autism spectrum disorder, intellectual disability, language, and&#xD;
                    speech disorders.&#xD;
  &#xD;
                 -  The family or the child not wanting to participate in the study.&#xD;
  &#xD;
          For the control group;&#xD;
  &#xD;
            -  Having any history of upper respiratory tract infection in the period up to two weeks&#xD;
               before the data collection date.&#xD;
  &#xD;
            -  Having any known neurological, systemic, or endocrinological diseases affecting the&#xD;
               voice.&#xD;
  &#xD;
            -  Having undergone vocal surgery or received voice therapy.&#xD;
  &#xD;
            -  Having a diagnosis of current hearing loss.&#xD;
  &#xD;
            -  Having a neurological or psychiatric diagnosis.&#xD;
  &#xD;
            -  Having a diagnosis of language and speech disorders.&#xD;
  &#xD;
            -  The family or the child not wanting to participate in the study.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>8 Years</minimum_age>
      <maximum_age>11 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Esra Özcebe, Professor</last_name>
      <role>Study Director</role>
      <affiliation>Istanbul University- Cerrahpaşa, Audiology Department</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Fatma Esen Aydınlı, Assoc. Prof.</last_name>
      <role>Study Chair</role>
      <affiliation>Hacettepe University, Speech and Language Therapy Departmant</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Özlem Beşik Topçu, SLP</last_name>
      <role>Study Chair</role>
      <affiliation>Hacettepe University, Speech and Language Therapy</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Meltem Çiğdem Kirazlı, Ph.D.</last_name>
      <role>Study Chair</role>
      <affiliation>Hacettepe University, Speech and Language Therapy</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Nur Seda Saban Dülger, SLP</last_name>
      <role>Study Chair</role>
      <affiliation>Hacettepe University, Speech and Language Therapy</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Merve Öğülmüş Uysal, SLP</last_name>
      <role>Study Chair</role>
      <affiliation>Hacettepe University, Speech and Language Therapy</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Halime Tuna Çak Esen, Assos. Prof.</last_name>
      <role>Study Chair</role>
      <affiliation>Independent Researcher</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Cihan Aslan, Dr.</last_name>
      <role>Study Chair</role>
      <affiliation>Hacettepe University Faculty of Medicine Department of Pediatric Mental Health And Diseases</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Esra Özcebe, Professor</last_name>
      <phone>(+90)2124400198</phone>
      <email>eozcebe@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Hacettepe University, Speech and Language Therapy</name>
        <address>
          <city>Ankara</city>
          <country>Turkey</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Özlem Beşik Topçu, SLP</last_name>
        <phone>(+90)5385032233</phone>
        <email>ozlembesik@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 30, 2023</study_first_submitted>
    <study_first_submitted_qc>September 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 11, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Hacettepe University</investigator_affiliation>
      <investigator_full_name>Özlem Beşik Topçu</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>voice disorders in children</keyword>
    <keyword>ADHD</keyword>
    <keyword>attention deficit and hyperactivity disorder</keyword>
    <keyword>vocal behaviors in children</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Voice Disorders</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06030583
  org study id: HUSLP_ADHD_VOICE
  nct id: NCT06030583
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The aim is to gain information about vocal hygiene knowledge level, phonotrauma behavior
        frequency, voice-related quality of life, and voice handicap index scores in children
        diagnosed with ADHD aged 8 to 11, through inter-group comparisons of scale and questionnaire
        data between children diagnosed with ADHD and control group participants aged 8 to 11.
  The study will include children aged 8 to 11 with and without a diagnosis of Attention
        Deficit Hyperactivity Disorder (ADHD). The study and control groups have been determined with
        age and gender matching.
  
        Within the scope of the study, a comparison between groups will be conducted through the
        scores of the Vocal Hygiene Awareness form, Pediatric Phonotrauma Assessment Questions for
        Parents, Voice Related Quality of Life Survey, and the Teacher-Reported Pediatric Voice
        Handicap Index to examine whether there are any differences between the groups. The Vocal
        Hygiene Awareness form will be completed by the child. The Pediatric Phonotrauma Assessment
        Questions for Parents, Voice Related Quality of Life Survey, and the Pediatric Voice Handicap
        Index will be completed by the parents. The Teacher-Reported Pediatric Voice Handicap Index
        will be filled out by the child's teacher.
  
        The number of participants to be included in the study has been calculated using G Power 3.1
        program. Based on an analysis with a power of 0.80 and α (type 1 error) = 0.05 using an
        independent t-test, 42 participants for each group, totaling 84 participants, are planned to
        be included in the study. Data analysis will be carried out using IBM SPSS Statistics 23
        program. Firstly, the normal distribution of ordinal variables will be tested. If the
        assumption of normality is met, parametric tests will be used; otherwise, non-parametric
        tests will be employed. A statistical significance value of p < 0.05 will be considered.
  observational model: Case-Control
  time perspective: Cross-Sectional
  measure: Inter-group Differences Associated with Phonotraumatic Behaviors
  time frame: The process of collecting data from participants once takes approximately 30 minutes
  description: Scores Obtained from Pediatric Phonotrauma Assessment Questions for Parents
  measure: Inter-group Differences Associated with Vocal Hygiene Knowledge
  time frame: The process of collecting data from participants once takes approximately 30 minutes
  description: Scores Obtained from Questions on Vocal Hygiene Awareness
  measure: Inter-group Differences Associated with Voice Related Quality of Life Survey
  time frame: The process of collecting data from participants once takes approximately 30 minutes
  description: Scores Obtained from the Voice Related Quality of Life Survey
  measure: Inter-group Differences Associated with the Teacher-Reported Pediatric Voice Handicap Index
  time frame: The process of collecting data from participants once takes approximately 30 minutes
  description: Scores Obtained from the Teacher-Reported Pediatric Voice Handicap Index
  arm group label: Study Group
  description: The research group comprises children aged 8 to 11 diagnosed with Attention Deficit Hyperactivity Disorder.
  arm group label: Control Group
  description: The control group consists of children aged 8 to 11 who do not have a diagnosis of ADHD, matched in terms of age and gender with the research group.
  intervention type: Other
  intervention name: Scales and Forms
  description: This study does not involve any interventions. Information will be collected from the study group and the control group through scales and forms.
  arm group label: Control Group
  arm group label: Study Group
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 8 Years
  maximum age: 11 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Esra Özcebe, Professor
  role: Study Director
  affiliation: Istanbul University- Cerrahpaşa, Audiology Department
  last name: Fatma Esen Aydınlı, Assoc. Prof.
  role: Study Chair
  affiliation: Hacettepe University, Speech and Language Therapy Departmant
  last name: Özlem Beşik Topçu, SLP
  role: Study Chair
  affiliation: Hacettepe University, Speech and Language Therapy
  last name: Meltem Çiğdem Kirazlı, Ph.D.
  role: Study Chair
  affiliation: Hacettepe University, Speech and Language Therapy
  last name: Nur Seda Saban Dülger, SLP
  role: Study Chair
  affiliation: Hacettepe University, Speech and Language Therapy
  last name: Merve Öğülmüş Uysal, SLP
  role: Study Chair
  affiliation: Hacettepe University, Speech and Language Therapy
  last name: Halime Tuna Çak Esen, Assos. Prof.
  role: Study Chair
  affiliation: Independent Researcher
  last name: Cihan Aslan, Dr.
  role: Study Chair
  affiliation: Hacettepe University Faculty of Medicine Department of Pediatric Mental Health And Diseases
  last name: Esra Özcebe, Professor
  phone: (+90)2124400198
  email: eozcebe@gmail.com
  facility: 
  status: Recruiting
  contact: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Hacettepe University
  investigator full name: Özlem Beşik Topçu
  investigator title: Principal Investigator
  mesh term: Voice Disorders