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Completed

NCT Number: NCT06030583

The Investigation of Vocal Behaviors in Children With ADHD

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.

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Key information

Age range

8 year–11 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hacettepe University, Speech and Language Therapy

Ankara, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Scales and Forms

Other

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

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

    Scores Obtained from the Voice Related Quality of Life Survey

  2. 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

    Scores Obtained from the Teacher-Reported Pediatric Voice Handicap Index

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

An Investigation of Vocal Hygiene, Vocal Behaviors, and Quality of Life Associated With Voice in Children With and Without Attention Deficit Hyperactivity Disorder

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 11, 2023
Registry last updated
Jul 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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