Clinical trial NCT02721901: Integrated Eating Aversion Treatment Manual-Parent Version
Official title: Development and Assessment of iEAT for Use by Parents in the Home Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Feeding and Eating Disorders of Childhood
Keywords: Gastrointestinal Disorders
Nutrition
Behavioral
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2016-03-29
Enrollment: 17
Sex: ALL
Minimum age (years): 12
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility 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

Primary outcomes:
measure: Change in acceptance of food during a 10-minute meal
timeFrame: Baseline, end of follow-up (up to 22 weeks)
Secondary outcomes:
measure: Change in disruptions during a 10-minute meal
timeFrame: Baseline, end of follow-up (up to 22 weeks)
measure: Change in grams of food consumed during a 10-minute meal
timeFrame: Baseline, end of follow-up (up to 22 weeks)
measure: Change in Clinical Global Impression - Improvement scale (CGI-I) score
timeFrame: Baseline, end of follow-up (up to 22 weeks)
measure: Change in Parenting Stress Index-Short Form (PSI) score
timeFrame: Baseline, end of follow-up (up to 22 weeks)
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Marcus Autism Center
state: Georgia
Study officials:
affiliation: Emory University
name: William Sharp, PhD
role: PRINCIPAL_INVESTIGATOR
References: