Feeding and Eating Disorders of Childhood Clinical Trial
Official title:
Development of a Manual-based, Technology-supported, Behavioral Feeding Intervention
This investigation proposes to examine the effectiveness of a technology supported treatment
manual for pediatric feeding disorders. Children with pediatric feeding disorders display
intense avoidance behaviors (e.g., crying, tantrums, and disruptions) that prevent
appropriate nutritional intake during meals and lead to a number of negative and potentially
life threatening medical outcomes, including chronic malnutrition, growth retardation, and
placement of a feeding tube. To date, behavioral intervention involving extinction-based
procedures represents the only treatment for pediatric feeding disorders supported by
research to improve mealtime behaviors. Due to the chronic and extreme nature of food
refusal, treatment typically requires intensive, daily intervention conducted at highly
specialized clinics to improve feeding behaviors. The cost and duration of intervention can
total as much as $60,000 per child requiring up to 6 to 8 weeks, respectively. The potential
for serious consequences associated with chronic food refusal, combined with the high cost
of treatment, intensifies the need to identify means to disseminate effective treatment
approaches to the broader community of healthcare providers.
The proposed study represents the first attempt to systematically investigate the use of a
treatment manual to address chronic food aversion through a randomized, waitlist control
trial in children treated at the Marcus Autism Center's Pediatrics Feeding Disorders
Program. This study will involve a total of 20 participants randomly assigned to
experimental conditions: technology supported treatment manual or waitlist control group (10
in each group). Children assigned to the waitlist control group will receive the technology
supported treatment manual after the specified time on the waitlist. All participants will
receive the same behavioral protocol involving three treatment sessions per day (45 minutes
in length), for a total of 15 sessions across five consecutive days. Data will be collected
on feeding behaviors during each treatment session and at follow-up using trained observers
to collect data on mealtime behaviors, including acceptance, swallowing, disruption,
expulsion, and grams consumed. This type of data collection and treatment is standard
practice in the feeding disorders program; however, the use of a touch screen application
for data capture with integrated manual is novel to this project.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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