Prospective Study of Voice Therapy in Children: A Pilot Study
Condition: Vocal Fold Nodules
Study type: Interventional

Summary: 
      The purpose of this prospective study is to obtain preliminary data on changes in pre-post
      voice therapy outcomes in children diagnosed with vocal fold nodules, as a function of a
      series of cognitive operations. The primary outcome is voice-related quality of life
      (questionnaire). Secondary outcomes are standard acoustic and aerodynamic measures derived
      from sustained vowel and running speech samples.
    

Detailed description: 
      -  Voice disorders are the most common communication disorder across the lifespan,
           affecting more than 5 million school-aged children annually in the United States.

        -  Vocal fold nodules are the most frequent pathology affecting voice in children, and may
           affect up to 21% of the pediatric population at any given point in time.

        -  Children with voice disorders caused by this and other conditions often experience
           negative consequences in quality of life and academic participation.

        -  Specifically, these children are at increased risk for inferior school performance,
           dysfunctional psychosocial development, and other negative sequelae.

        -  Overwhelmingly, the first-line treatment for voice problems due to nodules is behavioral
           voice therapy.

        -  Unfortunately, the pediatric population is badly underserved by Speech-Language
           Pathology for this condition and others affecting voice.

        -  Moreover, to date, experimental findings on the benefits of voice therapy in children
           have not been reported.

        -  In the present study, children who present with voice complaints to the Department of
           Otolaryngology at Children's Hospital of Pittsburgh (CHP), who are diagnosed with vocal
           fold nodules, and who following informed consent are found to satisfy other inclusion
           criteria detailed shortly, will be eligible for participation in the study.

        -  Eligible children will undergo a 45-60-min battery of standardized tests evaluating
           simple cognitive functions.

        -  Participation in the protocol will not depend on the outcome of these tests.

        -  Then, all children will receive an increasingly used, 9-week program of voice therapy
           for children with vocal fold nodules and other conditions affecting voice, "Adventures
           in Voice," a program grounded in basic biomechanical, biological, and cognitive science.

        -  Dependent variables will be pre- to post-therapy change in voice-related
           quality-of-life, based on the Pediatric Voice-Related Quality of Life Survey (Boseley,
           Cunningham, Volk, & Hartnick, 2006) (primary outcome measure) and change in a series of
           standard acoustic and aerodynamic measures based on sustained vowel and simple running
           speech samples, described shortly (secondary outcome measures).

        -  The independent variables involve a series of cognitive measures.
    

Intervention name(s): Adventures in Voice: Pediatric Voice Therapy
Intervention type(s): Behavioral
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: vocal fold nodules; pediatric; voice therapy; acoustic; aerodynamic; quality of life; Adventures in Voice