Integrated Eating Aversion Treatment Manual-Parent Version (iEAT)

October 13, 2017 updated by: William Sharp, PhD, Emory University

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.

Study Overview

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 Type

Interventional

Enrollment (Actual)

17

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Georgia
      • Atlanta, Georgia, United States, 30329
        • Marcus Autism Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 8 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria, for the child:

  • The child demonstrates failure to meet appropriate nutritional and/or energy needs based on Diagnostic and Statistical Manual (DSM)-V criteria (American Psychiatric Association, 2013) for Avoidant/Restrictive Food Intake Disorder
  • Present with partial food refusal as evidenced by greater than 50% of caloric needs met by bottle, formula, or tube feedings
  • Have a medical history significant for an organic factor (e.g., gastrointestinal issues) which precipitated or played a role in the development of feeding concern

Inclusion Criteria, for the parent/caretaker:

  • Must be English literate
  • Must have access to an iPad or a computer

Exclusion Criteria, for the child:

  • Patients with active medical diagnoses requiring hospitalization or significant oversight from a physician
  • Patients with active medical, structural, or functional limitations preventing safe oral intake of pureed foods (e.g., aspiration, upper airway obstruction)

Exclusion Criteria, for the parent/caretaker:

  • Caregivers do not commit to implementing the structured feeding protocol at least 2 times daily

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
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.
ACTIVE_COMPARATOR: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in acceptance of food during a 10-minute meal
Time Frame: 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.
Baseline, end of follow-up (up to 22 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in disruptions during a 10-minute meal
Time Frame: 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.
Baseline, end of follow-up (up to 22 weeks)
Change in grams of food consumed during a 10-minute meal
Time Frame: 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.
Baseline, end of follow-up (up to 22 weeks)
Change in Clinical Global Impression - Improvement scale (CGI-I) score
Time Frame: 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.
Baseline, end of follow-up (up to 22 weeks)
Change in Parenting Stress Index-Short Form (PSI) score
Time Frame: 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.
Baseline, end of follow-up (up to 22 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 1, 2016

Primary Completion (ACTUAL)

June 26, 2017

Study Completion (ACTUAL)

August 1, 2017

Study Registration Dates

First Submitted

March 23, 2016

First Submitted That Met QC Criteria

March 23, 2016

First Posted (ESTIMATE)

March 29, 2016

Study Record Updates

Last Update Posted (ACTUAL)

October 16, 2017

Last Update Submitted That Met QC Criteria

October 13, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Feeding and Eating Disorders of Childhood

Clinical Trials on iEAT Manual Intervention

Subscribe