Evaluation of the Feasibility and Preliminary Efficacy of the Parent-Mediated Integrated Eating Aversion Treatment (iEAT) Manual
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Change in Percent Oral Intake
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Months 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Active medical diagnoses requiring hospitalization or significant oversight from a physician
- •Active medical, structural, or functional limitations preventing safe oral intake of pureed foods
结局指标
主要结局
Change in Percent Oral Intake
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Change in Parenting Stress Index (PSI) Score(Baseline, Post-Intervention (Week 20))
研究者
Lindsey Burrell
Assistant Professor
Emory University