The Investigation of Vocal Behaviors in Children With ADHD

Voice Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06030583
• Other study ID #: HUSLP_ADHD_VOICE
• Status: Completed
• Start date: August 31, 2023
• Est. completion date: December 30, 2023

Study information

• Verified date: January 2024
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 control group participants aged 8 to 11.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 30, 2023
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 11 Years

Eligibility

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.

Related Conditions & MeSH terms

• Voice
• Voice Disorders
• Voice Disorders in Children

Intervention

Other:
• Scales and Forms
This study does not involve any interventions. Information will be collected from the study group and the control group through scales and forms.

Locations

Country	Name	City	State
Turkey	Hacettepe University, Speech and Language Therapy	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inter-group Differences Associated with Phonotraumatic Behaviors	Scores Obtained from Pediatric Phonotrauma Assessment Questions for Parents	The process of collecting data from participants once takes approximately 30 minutes
Primary	Inter-group Differences Associated with Vocal Hygiene Knowledge	Scores Obtained from Questions on Vocal Hygiene Awareness	The process of collecting data from participants once takes approximately 30 minutes
Secondary	Inter-group Differences Associated with Voice Related Quality of Life Survey	Scores Obtained from the Voice Related Quality of Life Survey	The process of collecting data from participants once takes approximately 30 minutes
Secondary	Inter-group Differences Associated with the Teacher-Reported Pediatric Voice Handicap Index	Scores Obtained from the Teacher-Reported Pediatric Voice Handicap Index	The process of collecting data from participants once takes approximately 30 minutes