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Completed

NCT Number: NCT02721901

Integrated Eating Aversion Treatment Manual-Parent Version

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.

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Key information

Conditions

Feeding and Eating Disorders of Childhood Behavior Digestive System Diseases Feeding and Eating Disorders Gastrointestinal Diseases Mental Disorders

Age range

12 month–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Marcus Autism Center

Atlanta, Georgia, 30329, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

iEAT Manual Intervention

Behavioral

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.

Control Group

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Emory University

Other

Registry information

Official study title

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

Acronym: iEAT

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 29, 2016
Registry last updated
Oct 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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