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.
Tutkimuksen yleiskatsaus
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Ilmoittautuminen (Todellinen)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskelupaikat
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Georgia
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Atlanta, Georgia, Yhdysvallat, 30322
- Children's Healthcare of Atlanta
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
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
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Ei käytössä
- Inventiomalli: Yksittäinen ryhmätehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
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Kokeellinen: 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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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Change in Percent Oral Intake
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Change in Parenting Stress Index (PSI) Score
Aikaikkuna: 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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Yhteistyökumppanit ja tutkijat
Sponsori
Tutkijat
- Päätutkija: Lindsey Burrell, MD, Emory University
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Todellinen)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- IRB00099562
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
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