- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06030583
The Investigation of Vocal Behaviors in Children With ADHD
An Investigation of Vocal Hygiene, Vocal Behaviors, and Quality of Life Associated With Voice in Children With and Without Attention Deficit Hyperactivity Disorder
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: Esra Özcebe, Professor
- Phone Number: (+90)2124400198
- Email: eozcebe@gmail.com
Study Locations
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-
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Ankara, Turkey
- Hacettepe University, Speech and Language Therapy
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
For study group
- Having been diagnosed with ADHD according to DSM-5 (The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition) diagnostic criteria
- Being in the age range of 8-11
- Having Turkish as the native language
- To have a score below the cut-off score (<13) on the Turkish Pediatric Voice Handicap Index.
For the control group:
- Not having any psychiatric diagnosis
- Being in the age range of 8-11
- Having Turkish as the native language
- To have a score below the cut-off score (<13) on the Turkish Pediatric Voice Handicap Index.
Exclusion Criteria:
For the research group;
- Having any history of upper respiratory tract infection in the period up to two weeks before the data collection date (one of the questionnaire requests considering the last two-week period as a reference).
- Having any known neurological, systemic, or endocrinological diseases affecting the voice.
- Having undergone vocal surgery or received voice therapy.
- Having a diagnosis of current hearing loss.
- Having comorbid autism spectrum disorder, intellectual disability, language, and speech disorders.
- The family or the child not wanting to participate in the study.
For the control group;
- Having any history of upper respiratory tract infection in the period up to two weeks before the data collection date.
- Having any known neurological, systemic, or endocrinological diseases affecting the voice.
- Having undergone vocal surgery or received voice therapy.
- Having a diagnosis of current hearing loss.
- Having a neurological or psychiatric diagnosis.
- Having a diagnosis of language and speech disorders.
- The family or the child not wanting to participate in the study.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Study Group
The research group comprises children aged 8 to 11 diagnosed with Attention Deficit Hyperactivity Disorder.
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This study does not involve any interventions.
Information will be collected from the study group and the control group through scales and forms.
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Control Group
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.
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This study does not involve any interventions.
Information will be collected from the study group and the control group through scales and forms.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Inter-group Differences Associated with Phonotraumatic Behaviors
Time Frame: The process of collecting data from participants once takes approximately 30 minutes
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Scores Obtained from Pediatric Phonotrauma Assessment Questions for Parents
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The process of collecting data from participants once takes approximately 30 minutes
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Inter-group Differences Associated with Vocal Hygiene Knowledge
Time Frame: The process of collecting data from participants once takes approximately 30 minutes
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Scores Obtained from Questions on Vocal Hygiene Awareness
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The process of collecting data from participants once takes approximately 30 minutes
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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Scores Obtained from the Voice Related Quality of Life Survey
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The process of collecting data from participants once takes approximately 30 minutes
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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
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Scores Obtained from the Teacher-Reported Pediatric Voice Handicap Index
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The process of collecting data from participants once takes approximately 30 minutes
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Esra Özcebe, Professor, Istanbul University- Cerrahpaşa, Audiology Department
- Study Chair: Fatma Esen Aydınlı, Assoc. Prof., Hacettepe University, Speech and Language Therapy Departmant
- Study Chair: Özlem Beşik Topçu, SLP, Hacettepe University, Speech and Language Therapy
- Study Chair: Meltem Çiğdem Kirazlı, Ph.D., Hacettepe University, Speech and Language Therapy
- Study Chair: Nur Seda Saban Dülger, SLP, Hacettepe University, Speech and Language Therapy
- Study Chair: Merve Öğülmüş Uysal, SLP, Hacettepe University, Speech and Language Therapy
- Study Chair: Halime Tuna Çak Esen, Assos. Prof., Independent Researcher
- Study Chair: Cihan Aslan, Dr., Hacettepe University Faculty of Medicine Department of Pediatric Mental Health And Diseases
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HUSLP_ADHD_VOICE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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