Clinical Trial: Integrated Eating Aversion Treatment Manual-Parent Version

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Development and Assessment of iEAT for Use by Parents in the Home Setting

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 Summary:

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.


Sponsor: Emory University

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.
  • 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.
  • 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.
  • 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.


Original Secondary Outcome: Same as current

Information By: Emory University

Dates:
Date Received: March 23, 2016
Date Started: March 2016
Date Completion: January 2018
Last Updated: September 29, 2016
Last Verified: September 2016