Gastrointestinal Disorders Clinical Trial
Official title:
Evaluation of the Feasibility and Preliminary Efficacy of the Parent-Mediated Integrated Eating Aversion Treatment (iEAT) Manual
The purpose of this study is to learn more about the eating behaviors of children with
chronic food refusal. Specifically, investigator's aim to see how the integrated Eating
Aversion Treatment (iEAT) may affect a child's food consumption. The manual is a structured
multidisciplinary treatment, including a psychologist and dietitian with consultation from a
speech-language pathologist. The treatment is designed to increase the volume of foods a
child eats and decrease their reliance on a feeding tube or formula. The manual includes
informational handouts, data collection forms, and instructions to guide the increase in
feeding demands while reducing reliance on formula to meet a child's nutritional needs.
Children with chronic food refusal will participate in this study at the Marcus Autism
Center. All children who enroll will receive the iEAT treatment. This involves 10 bi-weekly
sessions that last approximately one hour, over the course of 5 months and a 1 month
follow-up visit. Therefore, the study will last a total of 6 months.
This study seeks to further the development of iEAT by including participants that
demonstrated improvements in a previously conducted pilot study, and finalize the treatment
manual to include the standardized decision rules to increase feeding demands, further
integrate the multidisciplinary team (nutrition and speech pathology), and include
supplementary sessions to better address individual treatment needs.
Investigators propose to enroll participants with chronic food refusal and formula or feeding
tube dependence. Treatment will involve 10 biweekly outpatient appointments and 1 follow-up
appointment of about 1 hour in length. Assessment and treatment will involve a
multidisciplinary team including behavioral psychology, speech pathology and nutrition.
Target behaviors including grams consumed, percent dependence on formula/feeding tube, and
the clinical global impression scale, which will be assessed during a meal observation, 3-day
food record, and evaluation with the dietitian and independent evaluator. Participants will
be assessed pre-treatment, mid-treatment, and post-treatment and complete a one month
follow-up to assess long term effects.
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