The Effect of Oral Candidiasis on the Speech Production, Feeding Skills, and Self-Concept of Children and Adolescents With Symptomatic HIV Infection

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00001448
First received: November 3, 1999
Last updated: March 3, 2008
Last verified: July 1999
  Purpose

The main objectives of this study are: 1) to determine whether various levels of severity of oral candidiasis (thrush) in the child are associated with different levels of speech production, feeding skills, and self-concept, and 2) to assess the effect of the reduction of oral thrush over time on the speech function, feeding skills, and self-concept in HIV-infected patients who already are receiving various antifungal medications for treatment of their thrush (Note: Decisions regarding antifungal therapy are made completely independent from this study).

Children with HIV disease, ages 6-21 years, who have oral thrush are eligible to paricipate in the study. The child and his/her parent will be asked to complete a variety of measures at specific time intervals over approximately one month during visits to the National Institutes of Health for treatment on other protocols. First, a nurse will rate the location and severity of thrush in the child's mouth. Then the parent will complete questionnaires assessing the effect of oral thrush on the child's feeding and speech skills and everyday functioning. Finally, the child will be administered a brief speech and oral-motor evaluation and will complete some questionnaires about how the thrush affects his/her day-to-day activities and self-concept.

The results of this study may help to better understand the cause of expressive language deficits observed in some children with HIV infection. More specifically, it will determine if any speech and feeding problems of HIV-infected children are associated with oral thrush. Learning more about the impact of oral thrush on the speech, feeding, and the self-concept of children with HIV disease may be used for parent and patient education and to develop rehabilitative recommendations to benefit HIV-infected patients with oral thrush.


Condition
Candidiasis, Oral
Eating Disorders
HIV Infections
Speech Disorders

Study Type: Observational
Official Title: The Effect of Oral Candidiasis on the Speech Production, Feeding Skills, and Self-Concept of Children and Adolescents With Symptomatic HIV Infection

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 50
Study Start Date: August 1995
Estimated Study Completion Date: June 2000
Detailed Description:

Language impairments in children with symptomatic HIV infection are associated with the direct effects of HIV on the central nervous system (CNS). Furthermore, expressive language is more vulnerable to the effects of HIV compared to receptive language (Wolters, et al., 1995). Several factors, however, are likely to be involved in producing the expressive language impairments observed in the HIV-infected pediatric population. Oral candidiasis (thrush), a fungal infection in the oral cavity that frequently appears in HIV-infected children (Walsh, 1994), also may contribute to speech and language deficits depending on the severity of the thrush. Feeding skills and self-concept may be negatively affected by oral thrush as well.

The effect of oral candidiasis on the speech production, feeding skills, and self-concept of children and adolescents with HIV infection will be examined in this pilot study. Several disciplines (Neuropsychology, Speech, Nursing, and Infectious Disease) will be involved to investigate the severity of oral candidiasis on various aspects of everyday behavior.

Interdisciplinary assessment of the ramifications of oral thrush on speech production and feeding skills have not been conducted to date in children or adolescents infected with HIV. Most studies have assessed only single dimensions or functions such as language or they have yielded only descriptive data, for example, regarding the severity of oral thrush. This pilot study, however, will investigate the association between oral thrush and speech and feeding dysfunction using some newly-developed measures. The study will also examine whether oral candidiasis may influence the self-concept of children and adolescents with HIV infection.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Children and adolescents with HIV infection, ages 6 through 21 years of age, who are treated in other protocols at the Pediatric Branch of the National Cancer Institute (NCI) and have oral candidiasis as determined by the Pediatric Nurse Practitioners, are eligible to participate in this study.

Children and adolescents with infections or diseases other than candidiasis affecting the oral cavity as determined by the PNP's during the physical exam will be excluded from the study.

Furthermore, patients who are identified by the speech pathologist to have oro-facial structural and/or functional abnormalities that cause a significant disturbance in speech, voice, or swallowing will be excluded.

Children will also not be able t participate in the study if they cannot understand the measures, even if the questions are read to them, which will be determined by the Neuropsychology staff.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00001448

Locations
United States, Maryland
National Cancer Institute (NCI)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00001448     History of Changes
Other Study ID Numbers: 950185, 95-C-0185
Study First Received: November 3, 1999
Last Updated: March 3, 2008
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Antifungal Therapy
Articulation
Behavior
Expressive Language
Thrush

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
Candidiasis
Candidiasis, Oral
Communicable Diseases
Disease
Eating Disorders
HIV Infections
Infection
Speech Disorders
Communication Disorders
Immune System Diseases
Immunologic Deficiency Syndromes
Language Disorders
Lentivirus Infections
Mental Disorders
Mouth Diseases
Mycoses
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Pathologic Processes
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Signs and Symptoms
Slow Virus Diseases
Stomatognathic Diseases
Virus Diseases

ClinicalTrials.gov processed this record on October 30, 2014