Integrated Eating Aversion Treatment Manual-Parent Version

NCT02721901 | Completed

• 1 other identifier: IRB00086399
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Feeding and Eating Disorders of Childhood

Keywords

Gastrointestinal Disorders; Nutrition; Behavioral

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, end of follow-up (up to 22 weeks)

Secondary Outcomes (4)

• Change in disruptions during a 10-minute meal

  Baseline, end of follow-up (up to 22 weeks)

• Change in grams of food consumed during a 10-minute meal

  Baseline, end of follow-up (up to 22 weeks)

• Change in Clinical Global Impression - Improvement scale (CGI-I) score

  Baseline, end of follow-up (up to 22 weeks)

• Change in Parenting Stress Index-Short Form (PSI) score

  Baseline, end of follow-up (up to 22 weeks)

Study Arms (2)

iEAT Manual Intervention

EXPERIMENTAL

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

Control group

ACTIVE COMPARATOR

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

Interventions

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.

iEAT Manual Intervention

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.

Control group

Eligibility Criteria

• Age: 12 Months - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Marcus Autism Center

Atlanta, Georgia, 30329, United States

Location

MeSH Terms

Conditions

Feeding and Eating Disorders of Childhood; Gastrointestinal Diseases; Behavior

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• William Sharp, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: March 23, 2016
• First Posted: March 29, 2016
• Study Start: March 1, 2016
• Primary Completion: June 26, 2017
• Study Completion: August 1, 2017
• Last Updated: October 16, 2017

Record last verified: 2017-10

Locations

US (1)