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

NCT03739047 | Completed

• 1 other identifier: HUM00143299
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Children with feeding disorders

Outcome Measures

Primary Outcomes (5)

• Change from baseline frequency of gags at 8 weeks, or when treatment goals are met

  Participants will be observed for gags to evaluate the effectiveness of Desensitization

  Baseline, up to eight weeks after first treatment visit

• Change from baseline latency to clean mouth at 8 weeks, or when treatment goals are met

  Participants will be observed for latency to clean mouth to evaluate the effectiveness of Desensitization

  Baseline, up to eight weeks after first treatment visit

• Change from baseline frequency of packs at 8 weeks,or when treatment goals are met

  Participants will be observed for number of packs to evaluate the effectiveness of Desensitization

  Baseline, up to eight weeks after first treatment visit

• Change from baseline frequency of emesis at 8 weeks, or when treatment goals are met

  Participants will be observed for emesis to evaluate the effectiveness of Desensitization

  Baseline, up to eight weeks after first treatment visit

• Change from baseline frequency of combined inappropriate behaviors (CI's) at 8 weeks, or when treatment goals are met

  Participants will be observed for CI's to evaluate the effectiveness of Desensitization

  Baseline, up to eight weeks after first treatment visit

Secondary Outcomes (10)

• Pediatric Eating Assessment Tool (PediEAT)

  Baseline (pre-treatment), up to eight weeks (post-treatment)

• Family Management Measure of Feeding Questionnaire (FaMM Feed)

  Baseline (pre-treatment), up to eight weeks (post-treatment)

• Parenting Stress Index-Short Form, 4th Edition (PSI4-SF)

  Baseline (pre-treatment), up to eight weeks (post-treatment)

• Child Oral and Motor Proficiency Scale (ChOMPS)

  Baseline (pre-treatment), up to eight weeks (post-treatment)

• Child Behavior Checklist (CBCL) for ages 1 1/2 to 5 years old

  Baseline (pre-treatment), up to eight weeks (post-treatment)

Study Arms (2)

Desensitization with flipped spoon

EXPERIMENTAL

Children in this study will receive behavioral feeding treatment. This arm will include desensitization.

Behavioral: Desensitization with flipped spoon

flipped spoon

PLACEBO COMPARATOR

Children in this study will receive behavioral feeding treatment.

Behavioral: flipped spoon

Interventions

Desensitization with flipped spoon BEHAVIORAL

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.

Desensitization with flipped spoon

flipped spoon BEHAVIORAL

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.

flipped spoon

Eligibility Criteria

• Age: 10 Months - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Behavior problems (i.e., spitting, crying, head turning, gagging, physical aggression) are interfering with feeding
• Medical causes of feeding disorder have been treated or are well-controlled without resolution of the feeding problem
• Normal feeding milestones have not been met or regression has occurred
• Enteral feeding dependence as defined by the participant relying on Nasal Gastric or gastrostomy-tube feedings in order to receive appropriate nutrition and gain weight
• Accepts a limited number of foods and limited volume of foods by mouth (i.e., not enough variety or volume to maintain growth and/or good nutritional status)

You may not qualify if:

• Children who had anatomical/active medical problems that prohibit safe oral intake will be excluded

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Feeding and Eating Disorders

Interventions

Desensitization, Psychologic

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Natalie Morris, MS

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 29, 2018
• First Posted: November 13, 2018
• Study Start: December 10, 2018
• Primary Completion: May 31, 2019
• Study Completion: May 31, 2019
• Last Updated: December 12, 2019

Record last verified: 2019-12

Locations

US (1)