Voice Disorders in ChildrenNCT06030583
The Investigation of Vocal Behaviors in Children With ADHD
An observational study of Voice Disorders in Children and Voice, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages 8 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Voice Disorders in Children, Voice
- What is being tested?
- Scales and Forms
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 31 Aug 2023to 30 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: The study group participants will be comprised of children aged 8 to 11 who have been diagnosed with ADHD in the Department of Child and Adolescent Psychiatry at Hacettepe University. Their inclusion in the study will be based on voluntary participation. For the control group, participants will be reached through the snowball sampling method, with age and gender matching, and their inclusion in the study will also be based on voluntary participation.
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hacettepe University, Speech and Language Therapy
Ankara
About this study
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
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.
Read the 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.
- Conditions
- Voice Disorders in Children, Voice
- Being tested
- Scales and Forms
- Keywords
- voice disorders in children, ADHD, attention deficit and hyperactivity disorder, vocal behaviors in children
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scales and FormsOther
This study does not involve any interventions. Information will be collected from the study group and the control group through scales and forms.
| Study group | Role | What they receive |
|---|---|---|
| Study Group | The research group comprises children aged 8 to 11 diagnosed with Attention Deficit Hyperactivity Disorder. Receives: Other: Scales and Forms | |
| 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. Receives: Other: Scales and Forms |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inter-group Differences Associated with Phonotraumatic Behaviors
Scores Obtained from Pediatric Phonotrauma Assessment Questions for Parents
Measured: The process of collecting data from participants once takes approximately 30 minutes
Inter-group Differences Associated with Vocal Hygiene Knowledge
Scores Obtained from Questions on Vocal Hygiene Awareness
Measured: The process of collecting data from participants once takes approximately 30 minutes
Secondary outcomes (2)
Inter-group Differences Associated with Voice Related Quality of Life Survey
Scores Obtained from the Voice Related Quality of Life Survey
Measured: The process of collecting data from participants once takes approximately 30 minutes
Inter-group Differences Associated with the Teacher-Reported Pediatric Voice Handicap Index
Scores Obtained from the Teacher-Reported Pediatric Voice Handicap Index
Measured: The process of collecting data from participants once takes approximately 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2023
- Study start31 Aug 2023
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Voice Disorders in ChildrenStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Özlem Beşik Topçu, Hacettepe University
- Investigators
- Esra Özcebe, Professor, Study director, Istanbul University- Cerrahpaşa, Audiology DepartmentFatma Esen Aydınlı, Assoc. Prof., Study chair, Hacettepe University, Speech and Language Therapy DepartmantÖzlem Beşik Topçu, SLP, Study chair, Hacettepe University, Speech and Language TherapyMeltem Çiğdem Kirazlı, Ph.D., Study chair, Hacettepe University, Speech and Language TherapyNur Seda Saban Dülger, SLP, Study chair, Hacettepe University, Speech and Language TherapyMerve Öğülmüş Uysal, SLP, Study chair, Hacettepe University, Speech and Language TherapyHalime Tuna Çak Esen, Assos. Prof., Study chair, Independent ResearcherCihan Aslan, Dr., Study chair, Hacettepe University Faculty of Medicine Department of Pediatric Mental Health And Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06030583
- Sponsor's protocol ID
- HUSLP_ADHD_VOICE
- Status last verified
- Jan 2024
- First submitted
- 30 Aug 2023
- Last updated
- 25 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06030583
- Acronym / sponsor ID
- HUSLP_ADHD_VOICE
- Conditions
- Voice Disorders in Children, Voice
- Keywords
- voice disorders in children, ADHD, attention deficit and hyperactivity disorder, vocal behaviors in children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 31 Aug 2023 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 11 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | – | Other: Scales and FormsThe research group comprises children aged 8 to 11 diagnosed with Attention Deficit Hyperactivity Disorder. |
| Control Group | – | Other: Scales and FormsThe 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. |
Who may qualify
- Ages
- 8 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The study group participants will be comprised of children aged 8 to 11 who have been diagnosed with ADHD in the Department of Child and Adolescent Psychiatry at Hacettepe University. Their inclusion in the study will be based on voluntary participation. For the control group, participants will be reached through the snowball sampling method, with age and gender matching, and their inclusion in the study will also be based on voluntary participation.
Key inclusion criteria (10 listed)
- For study 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.
Key exclusion criteria (15 listed)
- For the research group;
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Scales and FormsThis study does not involve any interventions. Information will be collected from the study group and the control group through scales and forms. | Other | Control Group, Study Group |
Primary outcome
Inter-group Differences Associated with Phonotraumatic Behaviors
Time frame: The process of collecting data from participants once takes approximately 30 minutes
Scores Obtained from Pediatric Phonotrauma Assessment Questions for Parents
Inter-group Differences Associated with Vocal Hygiene Knowledge
Time frame: The process of collecting data from participants once takes approximately 30 minutes
Scores Obtained from Questions on Vocal Hygiene Awareness
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Esra Özcebe, Professor study director
Istanbul University- Cerrahpaşa, Audiology Department
Fatma Esen Aydınlı, Assoc. Prof. study chair
Hacettepe University, Speech and Language Therapy Departmant
Özlem Beşik Topçu, SLP study chair
Hacettepe University, Speech and Language Therapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Voice Disorders in Children and Voice, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inter-group Differences Associated with Phonotraumatic Behaviors (time frame: The process of collecting data from participants once takes approximately 30 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2024.