- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02721901
Integrated Eating Aversion Treatment Manual-Parent Version (iEAT)
Development and Assessment of iEAT for Use by Parents in the Home Setting
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Georgia
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Atlanta, Georgia, United States, 30329
- Marcus Autism Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: iEAT Manual Intervention
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.
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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.
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ACTIVE_COMPARATOR: Control group
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in acceptance of food during a 10-minute meal
Time Frame: Baseline, end of follow-up (up to 22 weeks)
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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.
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Baseline, end of follow-up (up to 22 weeks)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline, end of follow-up (up to 22 weeks)
|
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.
|
Baseline, end of follow-up (up to 22 weeks)
|
Change in Clinical Global Impression - Improvement scale (CGI-I) score
Time Frame: Baseline, end of follow-up (up to 22 weeks)
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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.
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Baseline, end of follow-up (up to 22 weeks)
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Change in Parenting Stress Index-Short Form (PSI) score
Time Frame: Baseline, end of follow-up (up to 22 weeks)
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The Parenting Stress Index-Short Form (PSI) is a 36-item survey commonly used will measure parental stress.
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Baseline, end of follow-up (up to 22 weeks)
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00086399
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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