Clinical trial NCT03739047: Desensitization to Reduce Oral Hypersensitivity and Improve Intake for Children With Feeding Disorders
Official title: The Impact of Desensitization as a Modality to Reduce Oral Hypersensitivity and Improve Intake in Children With Pediatric Feeding Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Feeding Disorder
Keywords: Children with feeding disorders
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2018-11-13
Enrollment: 7
Sex: ALL
Minimum age (years): 10
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Children with complex medical histories may have limited, delayed, or no early oral feeding experiences, which decreases the likelihood of independently developing appropriate oral motor skills required for eating. Children who are introduced to solid foods after 6-7 months of age frequently gag, choke, or vomit due to inefficient oral-motor skills. In typically developing children, gagging weakens as a child learns to chew around 7-months of age. However, children with feeding disorders do not have the same opportunities to weaken the natural gag reflex due to limited experience with oral feedings. As a result, they often become hypersensitive to any tactile stimulation and averse to foods and utensils touching specific parts of the mouth. There is a gap in the behavioral feeding literature addressing oral hypersensitivity and behaviors that interfere with swallowing (i.e., packing, expelling, gagging, vomiting). Some work surrounding desensitization of the oral cavity has already been done within other disciplines (i.e., occupational therapists and speech and language pathologists); however, desensitization has not been well-defined, nor has it been empirically studied.

(1) Specific Aims: The proposed study is designed to assess the following aims:

1. Define an oral-desensitization protocol to improve oral intake and decrease gags and emesis in children with feeding disorders.
2. Evaluate the efficacy of the brief implementation of an oral-desensitization protocol alone and in combination with the antecedent-based procedure, flipped spoon.
3. To explore the relationship between behavioral feeding intervention and child oral and motor proficiency.
4. To explore the relationship between behavioral feeding intervention and parent and child outcomes including parenting stress, mealtime feeding behaviors, and general child behavioral functioning.

(2) Research Hypotheses: The proposed study is designed to test the following hypotheses:

* Effect of flipped spoon versus flipped spoon + desensitization. It is hypothesized that there will be a faster decrease in (1) gags, (2) latency to clean mouth, (3) packs, (4) emesis, and (5) CI's with those participants who receive oral desensitization prior to the flipped spoon intervention. It is also hypothesized that children who receive desensitization prior to flipped spoon will be able to transition back to an upright spoon more quickly when compared to children who did not receive desensitization.
* Effect of behavioral feeding intervention on child oral and motor proficiency. Exploratory analyses will be conducted to examine pre-test and post-test ratings of child oral and motor proficiency. It is anticipated that the oral-motor coordination of the participants will significantly improve.
* The relationship between behavioral feeding intervention and parent/child outcomes. Exploratory analyses will be conducted to examine pre-test and post-test ratings of parenting stress, mealtime feeding behaviors, and general child behavioral and emotional functioning. It is anticipated that parent-reported ratings in these areas will improve from pre-test to post-test.

Treatment:

Participants will be randomly assigned to one of two treatment groups: desensitization + traditional behavioral intervention or traditional behavioral intervention alone. All participants will be treated for a maximum of 40 treatment days, or until treatment goals have been met. A total of 3, 45-minute meals will be held each day for a total of 120 meals throughout treatment. Trained feeding therapists from the Interdisciplinary Pediatric Feeding Program at Mott Children's Hospital will conduct sessions in treatment rooms with one-way mirrors. Caregivers will be given the option to observe through the one-way mirror or stay in the treatment room with the participant. The behavioral intervention will involve a combination of escape extinction and antecedent manipulation of the food (e.g., limiting bite size, using a flipped spoon to deposit the bolus). The behavioral intervention plus desensitization will include the above in addition to desensitization of the oral cavity. Desensitization will occur for the first 3 meals. This involves systematically stimulating different areas of the oral cavity (cheeks, palate, tongue, sides of tongue) to provoke and ultimately decrease the gag response allowing eating to be easier for participants. Data will be collected throughout each meal. All feeding sessions will be recorded to ensure protocol fidelity and for the purposes of collecting reliability data.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

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

Primary outcomes:
measure: Change from baseline frequency of gags at 8 weeks, or when treatment goals are met
timeFrame: Baseline, up to eight weeks after first treatment visit
measure: Change from baseline latency to clean mouth at 8 weeks, or when treatment goals are met
timeFrame: Baseline, up to eight weeks after first treatment visit
measure: Change from baseline frequency of packs at 8 weeks,or when treatment goals are met
timeFrame: Baseline, up to eight weeks after first treatment visit
measure: Change from baseline frequency of emesis at 8 weeks, or when treatment goals are met
timeFrame: Baseline, up to eight weeks after first treatment visit
measure: Change from baseline frequency of combined inappropriate behaviors (CI's) at 8 weeks, or when treatment goals are met
timeFrame: Baseline, up to eight weeks after first treatment visit
Secondary outcomes:
measure: Pediatric Eating Assessment Tool (PediEAT)
timeFrame: Baseline (pre-treatment), up to eight weeks (post-treatment)
measure: Family Management Measure of Feeding Questionnaire (FaMM Feed)
timeFrame: Baseline (pre-treatment), up to eight weeks (post-treatment)
measure: Parenting Stress Index-Short Form, 4th Edition (PSI4-SF)
timeFrame: Baseline (pre-treatment), up to eight weeks (post-treatment)
measure: Child Oral and Motor Proficiency Scale (ChOMPS)
timeFrame: Baseline (pre-treatment), up to eight weeks (post-treatment)
measure: Child Behavior Checklist (CBCL) for ages 1 1/2 to 5 years old
timeFrame: Baseline (pre-treatment), up to eight weeks (post-treatment)
measure: Child Behavior Checklist (CBCL) for ages 6-10 years old
timeFrame: Baseline (pre-treatment), up to eight weeks (post-treatment)
measure: Change in Body Weight
timeFrame: Baseline (pre-treatment), up to eight weeks (post-treatment)
measure: Change in Height
timeFrame: Baseline (pre-treatment), up to eight weeks (post-treatment)
measure: Change in Mid-upper arm circumference
timeFrame: Baseline (pre-treatment), up to eight weeks (post-treatment)
measure: Change in Hand Grip Strength
timeFrame: Baseline (pre-treatment), up to eight weeks (post-treatment)
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Natalie Morris, MS
role: PRINCIPAL_INVESTIGATOR
References: