Feeding and Eating Disorders of Childhood Clinical Trial
Official title:
Development and Assessment of iEAT for Use by Parents in the Home Setting
The purpose of this study is to further develop the integrated Eating Aversion Treatment (iEAT) manual, which is designed to address chronic food aversion in children with chronic food refusal. This study will evaluate the feasibility and efficacy of the iEAT manual when it is used in the home home environment with caregivers.
The purpose of the current study is to further develop the integrated Eating Aversion
Treatment (iEAT) manual and address the unmet needs of many children with chronic food
refusal by providing a technology-based treatment that makes it easy for parents to
understand how to duplicate the models of institutional care. The study seeks to expand upon
this treatment by introducing the manual and procedures in an electronic form to be
implemented by caregivers in a home environment.
The study team aims to enroll 20 participants with chronic food refusal and formula or
feeding tube dependence. Participants will be randomly assigned to receive the iEAT manual
intervention with the technology supported manual or a control group (10 participants per
group). The intervention with the iEAT manual will involve 10 biweekly outpatient
appointments of about 45 minutes in length. Target behaviors will be assessed during each
treatment meal. Participants will be assessed pre-treatment and at a one month follow-up to
assess long term effects. Parents in the control group will provide a food diary once a
month, for 5 months. Those assigned to the control group will be able to cross-over to
receive the iEAT treatment manual following completion of post-study measures. Screening,
collecting data for outcomes measures, and the intervention will be conducted at the each
participant's home. Data will be collected on parent compliance with the treatment manual and
child food acceptance, nutritional intake, and refusal behaviors.
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