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Desensitization to Reduce Oral Hypersensitivity and Improve Intake for Children With Feeding Disorders

NCT03739047 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2019-12-12

No results posted yet for this study

Summary

Many children with feeding disorders frequently gag, vomit, spit out their food, and/or hold food in their cheeks. These behaviors make it difficult for children to eat enough food to grow. The purpose of this study is to evaluate if a specific behavioral feeding intervention called desensitization is an effective intervention to improve oral intake in children with feeding disorders by decreasing gagging, vomiting, spitting, and holding food in the cheeks. The study will enroll eligible children (6) and their caretakers (6) in the study and they will receive behavioral feeding treatment. All treatment sessions will be videotaped and the study will last a maximum 8 weeks after the first treatment visit, or until treatment goals have been met.

Conditions

  • Feeding Disorder

Interventions

BEHAVIORAL

Desensitization with flipped spoon

Both groups will begin with a baseline phase: escape extinction (non-removal of an upright small maroon spoon) plus continuous access to reinforcement. The baseline phase will take place for 3, 5-bite sessions or until the data become stable. The baseline phase will be followed by desensitization. Desensitization will be conducted for 3, 45-minute treatment meals. Puree will be presented on a flipped EZ spoon after the desensitization sessions are completed. Bite size will be gradually increased. Acceptance of an upright EZ spoon and eventually an upright maroon spoon will be probed based on stability of the data.

BEHAVIORAL

flipped spoon

Both groups will begin with a baseline phase: escape extinction (non-removal of an upright small maroon spoon) plus continuous access to reinforcement. The baseline phase will take place for 3, 5-bite sessions or until the data become stable. The baseline phase will be followed by puree being presented from a flipped EZ spoon. Bite size will be gradually increased. Acceptance of an upright EZ spoon and eventually an upright maroon spoon will be probed based on stability of the data.

Sponsors & Collaborators

Principal Investigators

  • Natalie Morris, MS · University of Michigan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
10 Months
Max Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-10
Primary Completion
2019-05-31
Completion
2019-05-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03739047 on ClinicalTrials.gov