iEAT 2.0 Open Trial

Not Applicable

Completed

Brief Summary: The purpose of this study is to learn more about the eating behaviors of children with chronic food refusal. Specifically, investigator's aim to see how the integrated Eating Aversion Treatment (iEAT) may affect a child's food consumption. The manual is a structured multidisciplinary treatment, including a psychologist and dietitian with consultation from a speech-language pathologist. The treatment is designed to increase the volume of foods a child eats and decrease their reliance on a feeding tube or formula. The manual includes informational handouts, data collection forms, and instructions to guide the increase in feeding demands while reducing reliance on formula to meet a child's nutritional needs.

Children with chronic food refusal will participate in this study at the Marcus Autism Center. All children who enroll will receive the iEAT treatment. This involves 10 bi-weekly sessions that last approximately one hour, over the course of 5 months and a 1 month follow-up visit. Therefore, the study will last a total of 6 months.

Detailed Description: This study seeks to further the development of iEAT by including participants that demonstrated improvements in a previously conducted pilot study, and finalize the treatment manual to include the standardized decision rules to increase feeding demands, further integrate the multidisciplinary team (nutrition and speech pathology), and include supplementary sessions to better address individual treatment needs.

Investigators propose to enroll participants with chronic food refusal and formula or feeding tube dependence. Treatment will involve 10 biweekly outpatient appointments and 1 follow-up appointment of about 1 hour in length. Assessment and treatment will involve a multidisciplinary team including behavioral psychology, speech pathology and nutrition. Target behaviors including grams consumed, percent dependence on formula/feeding tube, and the clinical global impression scale, which will be assessed during a meal observation, 3-day food record, and evaluation with the dietitian and independent evaluator. Participants will be assessed pre-treatment, mid-treatment, and post-treatment and complete a one month follow-up to assess long term effects.

Recruitment & Eligibility

Inclusion Criteria

Present with partial food refusal as evidenced by greater than 75% of caloric needs met by bottle, formula, or tube feedings
Have a medical history significant for an organic factor (e.g., gastrointestinal issues) which influenced the development of feeding concern
Safe to consume up to 100% of his/her needs orally
Parents of subjects must be English literate
Ability to complete at least 2 structured meals each day

Exclusion Criteria

Active medical diagnoses requiring hospitalization or significant oversight from a physician
Active medical, structural, or functional limitations preventing safe oral intake of pureed foods

Arm && Interventions

Group	Intervention	Description
iEAT	iEAT Program	Children with food refusal will participate in the iEAT program.

Primary Outcome Measures

Name	Time	Method
Change in Percent Oral Intake	Baseline, Post-Intervention (Week 20)	Oral intake will be assessed through the three-day food diary on which parents will record the child's daily intake. The percent of needs consumed orally will be reported.
Change in Percent Needs Met by Formula or Feeding Tube	Baseline, Post-Intervention (Week 20)	Formula and feeding tube intake will be assessed through the three-day food diary on which parents will record the child's daily intake. The percent of needs consumed via bottle or tube will be reported.
Clinical Global Impression Scale - Improvement (CGI-I) Score	Post-Intervention (Week 20)	The CGI-I is a seven-point scale measure of 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. Total scores range from 1 to 7; where 1 indicates the most improvement and 7 indicates greatest worsening.
Change in Total Oral Grams Consumed During Meal	Baseline, Post-Intervention (Week 20)	Total oral grams consumed during a meal will be rated by trained observers captured by the meal observation form and collected during study visits.

Secondary Outcome Measures

Name	Time	Method
Change in Parenting Stress Index (PSI) Score	Baseline, Post-Intervention (Week 20)	The PSI is a 36-item measure completed by a parent or caregiver designed to screen for stress in the parent-child relationship, identifying dysfunctional parenting and child adjustment problems. Raw scores are converted into percentile scores. A score which falls between the 15th and 80th percentile is considered typical. High scores are those at or above the 85th percentile.

Locations (1): Children's Healthcare of Atlanta
🇺🇸
Atlanta, Georgia, United States