Integrated Eating Aversion Treatment Manual-Parent Version

Not Applicable

Completed

• Conditions: Feeding and Eating Disorders of Childhood
• Interventions: Behavioral: iEAT Manual Intervention; Behavioral: Control group

• Registration Number: NCT02721901
• Lead Sponsor: Emory University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-03-23
• Study First Submitted QC: 2016-03-23
• Study First Posted: 2016-03-29
• Primary Completion: 2017-06-26
• Study Completion: 2017-08-01
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-13
• Last Update Posted: 2017-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
iEAT Manual Intervention	iEAT Manual Intervention	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.
Control group	Control group	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.

Primary Outcome Measures

Name	Time	Method
Change in acceptance of food during a 10-minute meal	Baseline, end of follow-up (up to 22 weeks)	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.

Secondary Outcome Measures

Name	Time	Method
Change in grams of food consumed during a 10-minute meal	Baseline, end of follow-up (up to 22 weeks)	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.
Change in Clinical Global Impression - Improvement scale (CGI-I) score	Baseline, end of follow-up (up to 22 weeks)	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.
Change in Parenting Stress Index-Short Form (PSI) score	Baseline, end of follow-up (up to 22 weeks)	The Parenting Stress Index-Short Form (PSI) is a 36-item survey commonly used will measure parental stress.
Change in disruptions during a 10-minute meal	Baseline, end of follow-up (up to 22 weeks)	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.

Trial Locations

Locations (1)

Marcus Autism Center; 🇺🇸 Atlanta, Georgia, United States