Integrated Eating Aversion Treatment Manual-Parent Version (iEAT)

Emory University

Status: Completed

Conditions: Feeding and Eating Disorders of Childhood

Treatments: Behavioral: iEAT Manual Intervention; Behavioral: Control group

Study type: Interventional

Funder types: Other

Identifiers

NCT02721901

IRB00086399

Details and patient eligibility

About

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.

Full 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.

Enrollment: 17 patients

Sex: All

Ages: 12 months to 8 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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17 participants in 2 patient groups

iEAT Manual Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: iEAT Manual Intervention

Control group

Active Comparator group

Description:

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.

Treatment:

Behavioral: Control group