The Investigation of Vocal Behaviors in Children With ADHD

NCT ID: NCT06030583

Last Updated: 2024-07-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-08-31
• Study Completion Date: 2024-06-30

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.

Conditions

Voice Disorders in Children; Voice

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Study Group

The research group comprises children aged 8 to 11 diagnosed with Attention Deficit Hyperactivity Disorder.

Scales and Forms

Intervention Type: OTHER

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.

Scales and Forms

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hacettepe University

OTHER

Sponsor Role: lead

Responsible Party

Özlem Beşik Topçu

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Esra Özcebe, Professor

Role: STUDY_DIRECTOR

Istanbul University- Cerrahpaşa, Audiology Department

Fatma Esen Aydınlı, Assoc. Prof.

Role: STUDY_CHAIR

Hacettepe University, Speech and Language Therapy Departmant

Özlem Beşik Topçu, SLP

Role: STUDY_CHAIR

Hacettepe University, Speech and Language Therapy

Meltem Çiğdem Kirazlı, Ph.D.

Role: STUDY_CHAIR

Hacettepe University, Speech and Language Therapy

Nur Seda Saban Dülger, SLP

Role: STUDY_CHAIR

Hacettepe University, Speech and Language Therapy

Merve Öğülmüş Uysal, SLP

Role: STUDY_CHAIR

Hacettepe University, Speech and Language Therapy

Halime Tuna Çak Esen, Assos. Prof.

Role: STUDY_CHAIR

Independent Researcher

Cihan Aslan, Dr.

Role: STUDY_CHAIR

Hacettepe University Faculty of Medicine Department of Pediatric Mental Health And Diseases

Locations

Hacettepe University, Speech and Language Therapy

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

HUSLP_ADHD_VOICE

Identifier Type: -

Identifier Source: org_study_id