An interventional study of iEAT Manual Intervention and Control group in Feeding and Eating Disorders of Childhood, sponsored by Emory University. Completed at 1 site in United States. Open to participants aged 12 Months to 8 Years. Per ClinicalTrials.gov, last updated 2017-10-16.
Sponsored by Emory University · Not applicable, Interventional, and Treatment
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.
740 studies on the registry are indexed under Feeding and Eating Disorders; 159 are open to participants now.
This study's enrollment of 17 is below the median of 75 across 540 interventional studies indexed under Feeding and Eating Disorders.
Browse Feeding and Eating Disorders studies →Emory University is the lead sponsor of 1,386 studies on the registry; 236 are open to participants now.
Of its 229 completed or terminated interventional studies of FDA-regulated products, 174 (76%) have results posted.
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Inclusion Criteria, for the child:
Inclusion Criteria, for the parent/caretaker:
Exclusion Criteria, for the child:
Exclusion Criteria, for the parent/caretaker:
Caretakers of 10 children will be randomized to participate in the integrated Eating Aversion Treatment (iEAT) intervention. iEAT is a technology-based manual which aims to increase the child's food consumption.
Behavioral: iEAT Manual Intervention
Caretakers of 10 children will be randomized to participate in the control group. Participants assigned to the control group will be able to receive the iEAT treatment after the study ends.
Behavioral: Control group
The iEAT manual guides caretakers in increasing the volume of food consumed by the child. The manual involves a touch screen application that collects and stores data on key behaviors and provides the feeder with direction for structuring treatment meals. Sessions will be 45 minutes long and occur biweekly for 10 sessions over 5 months. Two meals each day will be completed at home as part of the treatment of the feeding problems.
The psychoeducation condition will involve 6 appointments (once monthly for 5 months and 1 session during the post-treatment assessment). Each appointment will include curriculum related to feeding concerns such as the etiology of feeding problems, meal structure, appropriate food selection, mealtime problem behaviors, and generalization of appropriate feeding behaviors. Each session will last approximately 45 minutes.
Change in acceptance of food during a 10-minute meal
A 10-minute meal observation to measure outcomes: acceptance, swallowing, disruption and grams consumed will be rated by trained observers using conventions established in our Feeding Disorders Program. This data collection system will also be used to record child and parent behaviors during outpatient therapy appointments to guide feedback.
Time frame: Baseline, end of follow-up (up to 22 weeks)
Change in disruptions during a 10-minute meal
A 10-minute meal observation to measure outcomes: acceptance, swallowing, disruption and grams consumed will be rated by trained observers using conventions established in our Feeding Disorders Program. This data collection system will also be used to record child and parent behaviors during outpatient therapy appointments to guide feedback.
Time frame: Baseline, end of follow-up (up to 22 weeks)
Change in grams of food consumed during a 10-minute meal
A 10-minute meal observation to measure outcomes: acceptance, swallowing, disruption and grams consumed will be rated by trained observers using conventions established in our Feeding Disorders Program. This data collection system will also be used to record child and parent behaviors during outpatient therapy appointments to guide feedback.
Time frame: Baseline, end of follow-up (up to 22 weeks)
Change in Clinical Global Impression - Improvement scale (CGI-I) score
The Clinical Global Impression - Improvement (CGI-I) scale is a seven-point scale measuring overall change from baseline. Scores will be ranked from 1 (Very Much Improved) through 4 (Unchanged) to 7 (Very Much Worse). Scores of "Much Improved" or "Very Much Improved" will be used to define positive responses; all other scores will indicate negative responses.
Time frame: Baseline, end of follow-up (up to 22 weeks)
Change in Parenting Stress Index-Short Form (PSI) score
The Parenting Stress Index-Short Form (PSI) is a 36-item survey commonly used will measure parental stress.
Time frame: Baseline, end of follow-up (up to 22 weeks)
This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
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Emory University