Gastrointestinal Disorders Clinical Trial
Official title:
Evaluation of the Feasibility and Preliminary Efficacy of the Parent-Mediated Integrated Eating Aversion Treatment (iEAT) Manual
Verified date | June 2019 |
Source | Emory University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 15 |
Est. completion date | April 25, 2019 |
Est. primary completion date | April 25, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Months to 6 Years |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Children's Healthcare of Atlanta | Atlanta | Georgia |
Lead Sponsor | Collaborator |
---|---|
Emory University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Baseline, Post-Intervention (Week 20) | |
Primary | 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. | Baseline, Post-Intervention (Week 20) | |
Primary | 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. | Baseline, Post-Intervention (Week 20) | |
Primary | 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. | Post-Intervention (Week 20) | |
Secondary | 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. | Baseline, Post-Intervention (Week 20) |
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