The Investigation of Vocal Behaviors in Children With ADHD

January 10, 2024 updated by: Özlem Beşik Topçu, Hacettepe University

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.

Study Overview

Status

Completed

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

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Esra Özcebe, Professor
  • Phone Number: (+90)2124400198
  • Email: eozcebe@gmail.com

Study Locations

      • Ankara, Turkey
        • Hacettepe University, Speech and Language Therapy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

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.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

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
Scores Obtained from Pediatric Phonotrauma Assessment Questions for Parents
The process of collecting data from participants once takes approximately 30 minutes
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
The process of collecting data from participants once takes approximately 30 minutes

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
Scores Obtained from the Voice Related Quality of Life Survey
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
Scores Obtained from the Teacher-Reported Pediatric Voice Handicap Index
The process of collecting data from participants once takes approximately 30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 31, 2023

Primary Completion (Actual)

December 30, 2023

Study Completion (Actual)

December 30, 2023

Study Registration Dates

First Submitted

August 30, 2023

First Submitted That Met QC Criteria

September 7, 2023

First Posted (Actual)

September 11, 2023

Study Record Updates

Last Update Posted (Estimated)

January 11, 2024

Last Update Submitted That Met QC Criteria

January 10, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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