An interventional study of iEAT Program in Gastrointestinal Disorders, sponsored by Emory University. Completed at 1 site in United States. Open to participants aged 12 Months to 6 Years. Per ClinicalTrials.gov, last updated 2019-06-21.
Sponsored by Emory University · Not applicable, Interventional, and Treatment
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.
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.
548 studies on the registry are indexed under Gastrointestinal Diseases; 101 are open to participants now.
This study's enrollment of 15 is below the median of 80 across 388 interventional studies indexed under Gastrointestinal Diseases.
Browse Gastrointestinal Diseases studies →Emory University is the lead sponsor of 1,405 studies on the registry; 225 are open to participants now.
Of its 237 completed or terminated interventional studies of FDA-regulated products, 178 (75%) have results posted.
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Exclusion Criteria:
Children with food refusal will participate in the iEAT program.
Behavioral: iEAT Program
The iEAT Program is a six-month long behavioral intervention consisting of 10 biweekly outpatient appointments of about 1 hour in length. The iEAT manual will guide behavioral intervention targeting severe feeding disorders and will involve some combination of escape extinction, reinforcement, and antecedent manipulation of food presentation to lessen the aversive quality of the meal.
Change in Percent Oral Intake
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.
Time frame: Baseline, Post-Intervention (Week 20)
Change in Total Oral Grams Consumed During Meal
Total oral grams consumed during a meal will be rated by trained observers captured by the meal observation form and collected during study visits.
Time frame: Baseline, Post-Intervention (Week 20)
Change in Percent Needs Met by Formula or Feeding Tube
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.
Time frame: Baseline, Post-Intervention (Week 20)
Clinical Global Impression Scale - Improvement (CGI-I) Score
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.
Time frame: Post-Intervention (Week 20)
Change in Parenting Stress Index (PSI) Score
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.
Time frame: Baseline, Post-Intervention (Week 20)
Ran from Nov 2017 to primary completion in Apr 2019, 16 months.
Of 127 non-industry interventional studies with no phase under Gastrointestinal Diseases, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 46. This study's 16 months is below that.
Counting every sponsor, half of 149 studies reached it within 24 months; a quarter within 10 and three quarters within 45.
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This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
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