NCT06030583

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 30, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

August 31, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 11, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

July 25, 2024

Status Verified

January 1, 2024

Enrollment Period

10 months

First QC Date

August 30, 2023

Last Update Submit

July 24, 2024

Conditions

Keywords

voice disorders in childrenADHDattention deficit and hyperactivity disordervocal behaviors in children

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (2)

  • Inter-group Differences Associated with 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

    The process of collecting data from participants once takes approximately 30 minutes

Study Arms (2)

Study Group

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

Other: 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.

Other: Scales and Forms

Interventions

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

Control GroupStudy Group

Eligibility Criteria

Age8 Years - 11 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University, Speech and Language Therapy

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Weights and Measures

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Esra Özcebe, Professor

    Istanbul University- Cerrahpaşa, Audiology Department

    STUDY DIRECTOR
  • 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 CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 30, 2023

First Posted

September 11, 2023

Study Start

August 31, 2023

Primary Completion

June 30, 2024

Study Completion

June 30, 2024

Last Updated

July 25, 2024

Record last verified: 2024-01

Locations