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iEAT 2.0 Open Trial

19. juni 2019 opdateret af: Lindsey Burrell, Emory University

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

15

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30322
        • Children's Healthcare of Atlanta

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

1 år til 6 år (Barn)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: iEAT
Children with food refusal will participate in the iEAT program.
Adfærdsmæssigt: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Percent Oral Intake
Tidsramme: 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.
Baseline, Post-Intervention (Week 20)
Change in Total Oral Grams Consumed During Meal
Tidsramme: 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.
Baseline, Post-Intervention (Week 20)
Change in Percent Needs Met by Formula or Feeding Tube
Tidsramme: 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.
Baseline, Post-Intervention (Week 20)
Clinical Global Impression Scale - Improvement (CGI-I) Score
Tidsramme: 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.
Post-Intervention (Week 20)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Parenting Stress Index (PSI) Score
Tidsramme: Baseline, Post-Intervention (Week 20)
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)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Emory University

Efterforskere

  • Ledende efterforsker: Lindsey Burrell, MD, Emory University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

29. november 2017

Primær færdiggørelse (Faktiske)

25. april 2019

Studieafslutning (Faktiske)

25. april 2019

Datoer for studieregistrering

Først indsendt

18. december 2017

Først indsendt, der opfyldte QC-kriterier

21. december 2017

Først opslået (Faktiske)

26. december 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

21. juni 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. juni 2019

Sidst verificeret

1. juni 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • IRB00099562

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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Kliniske forsøg med iEAT Program

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Sponsorer og samarbejdspartnere

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Betingelser

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Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner