iEAT 2.0 Open Trial
Evaluation of the Feasibility and Preliminary Efficacy of the Parent-Mediated Integrated Eating Aversion Treatment (iEAT) Manual
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.
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Georgia
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Atlanta, Georgia, 미국, 30322
- Children's Healthcare of Atlanta
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: iEAT
Children with food refusal will participate in the iEAT program.
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in Percent Oral Intake
기간: Baseline, Post-Intervention (Week 20)
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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.
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Baseline, Post-Intervention (Week 20)
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Change in Total Oral Grams Consumed During Meal
기간: Baseline, Post-Intervention (Week 20)
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Total oral grams consumed during a meal will be rated by trained observers captured by the meal observation form and collected during study visits.
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Baseline, Post-Intervention (Week 20)
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Change in Percent Needs Met by Formula or Feeding Tube
기간: Baseline, Post-Intervention (Week 20)
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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.
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Baseline, Post-Intervention (Week 20)
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Clinical Global Impression Scale - Improvement (CGI-I) Score
기간: Post-Intervention (Week 20)
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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.
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Post-Intervention (Week 20)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in Parenting Stress Index (PSI) Score
기간: Baseline, Post-Intervention (Week 20)
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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.
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Baseline, Post-Intervention (Week 20)
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공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Lindsey Burrell, MD, Emory University
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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