Clinical trial NCT06030583: The Investigation of Vocal Behaviors in Children With ADHD
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Voice Disorders in Children
Voice
Keywords: voice disorders in children
ADHD
attention deficit and hyperactivity disorder
vocal behaviors in children
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2023-09-11
Enrollment: 50
Sex: ALL
Minimum age (years): 8
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Inter-group Differences Associated with Phonotraumatic Behaviors
timeFrame: The process of collecting data from participants once takes approximately 30 minutes
measure: Inter-group Differences Associated with Vocal Hygiene Knowledge
timeFrame: The process of collecting data from participants once takes approximately 30 minutes
Secondary outcomes:
measure: Inter-group Differences Associated with Voice Related Quality of Life Survey
timeFrame: The process of collecting data from participants once takes approximately 30 minutes
measure: Inter-group Differences Associated with the Teacher-Reported Pediatric Voice Handicap Index
timeFrame: The process of collecting data from participants once takes approximately 30 minutes
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University, Speech and Language Therapy
Study officials:
affiliation: Istanbul University- Cerrahpaşa, Audiology Department
name: Esra Özcebe, Professor
role: STUDY_DIRECTOR
affiliation: Hacettepe University, Speech and Language Therapy Departmant
name: Fatma Esen Aydınlı, Assoc. Prof.
role: STUDY_CHAIR
affiliation: Hacettepe University, Speech and Language Therapy
name: Özlem Beşik Topçu, SLP
role: STUDY_CHAIR
affiliation: Hacettepe University, Speech and Language Therapy
name: Meltem Çiğdem Kirazlı, Ph.D.
role: STUDY_CHAIR
affiliation: Hacettepe University, Speech and Language Therapy
name: Nur Seda Saban Dülger, SLP
role: STUDY_CHAIR
affiliation: Hacettepe University, Speech and Language Therapy
name: Merve Öğülmüş Uysal, SLP
role: STUDY_CHAIR
affiliation: Independent Researcher
name: Halime Tuna Çak Esen, Assos. Prof.
role: STUDY_CHAIR
affiliation: Hacettepe University Faculty of Medicine Department of Pediatric Mental Health And Diseases
name: Cihan Aslan, Dr.
role: STUDY_CHAIR
References: