Feeding DisorderNCT03739047
Desensitization to Reduce Oral Hypersensitivity and Improve Intake for Children With Feeding Disorders
A study testing Desensitization with flipped spoon and flipped spoon in people with Feeding Disorder, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 months to 10 years
- Conditions the study is for
- Feeding Disorder
- What is being tested?
- Desensitization with flipped spoon and flipped spoon
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Dec 2018to 31 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 months to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- Children who had anatomical/active medical problems that prohibit safe oral intake will be excluded
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Desensitization as a Modality to Reduce Oral Hypersensitivity and Improve Intake in Children With Pediatric Feeding Disorders
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.
Read the 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:
- Define an oral-desensitization protocol to improve oral intake and decrease gags and emesis in children with feeding disorders.
- Evaluate the efficacy of the brief implementation of an oral-desensitization protocol alone and in combination with the antecedent-based procedure, flipped spoon.
- To explore the relationship between behavioral feeding intervention and child oral and motor proficiency.
- 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.
- Conditions
- Feeding Disorder
- Being tested
- Desensitization with flipped spoon, flipped spoon
- Keywords
- Children with feeding disorders
- Medical subject headings
- Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Desensitization with flipped spoonBehavioural
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.
flipped spoonBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Desensitization with flipped spoon | Experimental | Children in this study will receive behavioral feeding treatment. This arm will include desensitization. Receives: Behavioral: Desensitization with flipped spoon |
| flipped spoon | Placebo comparator | Children in this study will receive behavioral feeding treatment. Receives: Behavioral: flipped spoon |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline, up to eight weeks after first treatment visit
Secondary outcomes (10)
Pediatric Eating Assessment Tool (PediEAT)
This is a parent-report instrument that is comprised of 78 questions that assess feeding difficulties across 4 subscales including: physiologic symptoms, problematic mealtime behaviors, selective/restrictive eating, and oral processing. Caregivers are asked to "think about what is typical for your child at this time" and to select from a scale of 6 response options including (0) Never, (1) Almost Never, (2) Sometimes, (3) Often, (4) Almost Always, and (5) Always. Higher scores indicate more symptoms of problematic feeding.
Measured: Baseline (pre-treatment), up to eight weeks (post-treatment)
Family Management Measure of Feeding Questionnaire (FaMM Feed)
This is a 49 question survey that the parent/caregiver completes to evaluate mealtime feeding behaviors. Responses include: strongly disagree, disagree, neutral, agree, and strongly agree with each response score given is from 1-5 (1 = strongly disagree to strongly agree = 5). Lower scores indicating lower family management, or less feelings of being able to manage in the context of daily family life.
Measured: Baseline (pre-treatment), up to eight weeks (post-treatment)
Parenting Stress Index-Short Form, 4th Edition (PSI4-SF)
This is a 36-item self-report questionnaire that assesses the level of stress in a parent-child relationship for parents of children 0-12 years of age. Each item is rated on a five-point Likert scale (1 = Strongly Agree, 2 = Agree, 3 = Not Sure, 4 = Disagree, and 5 = Strongly Disagree). It yields three subscales: Parental Distress (PD), Parent-Child Dysfunctional Interaction (P-CDI), and Difficult Child (DC). Items are scored and added together to establish a total score as well as three subscale scores. The PSI-SF produces subscale raw scores ranging from 12 to 60 and an overall Parenting Stress (PSI-PS) total score that ranges from 36 to 180. Higher scores are indicative of a greater level of stress. A PSI-SF score above 85 indicates clinically significant parenting stress. The PSI-SF also includes a Defensive Responding (DR) scale to identify parents who might be attempting to minimize or deny problems.
Measured: Baseline (pre-treatment), up to eight weeks (post-treatment)
Child Oral and Motor Proficiency Scale (ChOMPS)
This is a parent-report assessment of eating and drinking in children 6 months to 7 years. Consisting of 63-items, caregivers are asked to indicate the child's ability to perform a skill by choosing 'yes' (established skill; score = 2), 'sometimes' (emerging skill; score = 1), and 'not yet' (not yet emerging skill; score = 0). Total scores range from 0-126 with higher scores indicating greater skills. This measure yields 4 subscales including: basic movement patterns, fundamental oral-motor skills, oral-motor coordination, and complex movement patterns.
Measured: Baseline (pre-treatment), up to eight weeks (post-treatment)
Child Behavior Checklist (CBCL) for ages 1 1/2 to 5 years old
The Checklist is a parent measure of emotional, behavioral and social problems in children ages 1.5-5 years. This 100-item measure yields broad-band scores of Internalizing Behavior Problems, Externalizing Behavior Problems, and Total Behavior Problems. It also yields eight additional problem scales: Anxious/Depressed, Withdrawn/Depressed, Somatic Complaints, Social Problems, Thought Problems, Attention Problems, Rule-Breaking Behavior, and Aggressive Behavior. Caregivers rate each behavior or symptom on a three-point scale: not true (0), somewhat or sometimes true (1), or very true or often true (2). A computer program will be used to calculate the T-scores for each scale. Raw scores are converted to gender and age standardized scores (T-scores having a mean of 50 and SD of 10). Internal consistency Chronbach's alphas for each subscale are moderately high, ranging from .63 to .79. Alphas range from .78 to .97 for broad-band problem scales.
Measured: Baseline (pre-treatment), up to eight weeks (post-treatment)
Child Behavior Checklist (CBCL) for ages 6-10 years old
The Checklist is a parent measure of emotional, behavioral and social problems in children ages 6-18 years. This 113-item measure yields broad-band scores of Internalizing Behavior Problems, Externalizing Behavior Problems, and Total Behavior Problems. It also yields eight additional problem scales: Anxious/Depressed, Withdrawn/Depressed, Somatic Complaints, Social Problems, Thought Problems, Attention Problems, Rule-Breaking Behavior, and Aggressive Behavior. Caregivers rate each behavior or symptom on a three-point scale: not true (0), somewhat or sometimes true (1), or very true or often true (2). A computer program will be used to calculate the T-scores for each scale. Raw scores are converted to gender and age standardized scores (T-scores having a mean of 50 and SD of 10). Internal consistency Chronbach's alphas for each subscale are moderately high, ranging from .63 to .79. Alphas range from .78 to .97 for broad-band problem scales.
Measured: Baseline (pre-treatment), up to eight weeks (post-treatment)
Change in Body Weight
Weight change from baseline
Measured: Baseline (pre-treatment), up to eight weeks (post-treatment)
Change in Height
Height change from baseline
Measured: Baseline (pre-treatment), up to eight weeks (post-treatment)
Change in Mid-upper arm circumference
Mid-upper arm circumference change from baseline
Measured: Baseline (pre-treatment), up to eight weeks (post-treatment)
Change in Hand Grip Strength
Change in Hand Grip Strength from baseline will be measured using a JAMAR hydraulic hand dynamometer.
Measured: Baseline (pre-treatment), up to eight weeks (post-treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2018
- Study start10 Dec 2018
- Primary completion31 May 2019
- Study completion31 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Feeding DisorderStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Natalie Morris, University of Michigan
- Investigators
- Natalie Morris, MS, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03739047
- Sponsor's protocol ID
- HUM00143299
- Status last verified
- Dec 2019
- First submitted
- 29 Oct 2018
- Last updated
- 12 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Desensitization as a Modality to Reduce Oral Hypersensitivity and Improve Intake in Children With Pediatric Feeding Disorders
- ClinicalTrials.gov ID
- NCT03739047
- Acronym / sponsor ID
- HUM00143299
- Conditions
- Feeding Disorder
- Keywords
- Children with feeding disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 10 Dec 2018 (actual)
- Primary completion
- 31 May 2019 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 13 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Define an oral-desensitization protocol to improve oral intake and decrease gags and emesis in children with feeding disorders.
- Evaluate the efficacy of the brief implementation of an oral-desensitization protocol alone and in combination with the antecedent-based procedure, flipped spoon.
- To explore the relationship between behavioral feeding intervention and child oral and motor proficiency.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Desensitization with flipped spoon | Experimental | Behavioral: Desensitization with flipped spoonChildren in this study will receive behavioral feeding treatment. This arm will include desensitization. |
| flipped spoon | Placebo comparator | Behavioral: flipped spoonChildren in this study will receive behavioral feeding treatment. |
Who may qualify
- Ages
- 10 months to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (1 listed)
- Children who had anatomical/active medical problems that prohibit safe oral intake will be excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Desensitization with flipped spoonBoth 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. | Behavioural | Desensitization with flipped spoon |
| flipped spoonBoth 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. | Behavioural | flipped spoon |
Primary outcome
Change from baseline frequency of gags at 8 weeks, or when treatment goals are met
Time frame: Baseline, up to eight weeks after first treatment visit
Participants will be observed for gags to evaluate the effectiveness of Desensitization
Change from baseline latency to clean mouth at 8 weeks, or when treatment goals are met
Time frame: Baseline, up to eight weeks after first treatment visit
Participants will be observed for latency to clean mouth to evaluate the effectiveness of Desensitization
Change from baseline frequency of packs at 8 weeks,or when treatment goals are met
Time frame: Baseline, up to eight weeks after first treatment visit
Participants will be observed for number of packs to evaluate the effectiveness of Desensitization
Change from baseline frequency of emesis at 8 weeks, or when treatment goals are met
Time frame: Baseline, up to eight weeks after first treatment visit
Participants will be observed for emesis to evaluate the effectiveness of Desensitization
Change from baseline frequency of combined inappropriate behaviors (CI's) at 8 weeks, or when treatment goals are met
Time frame: Baseline, up to eight weeks after first treatment visit
Participants will be observed for CI's to evaluate the effectiveness of Desensitization
10 secondary outcomes
Pediatric Eating Assessment Tool (PediEAT)
Time frame: Baseline (pre-treatment), up to eight weeks (post-treatment)
Family Management Measure of Feeding Questionnaire (FaMM Feed)
Time frame: Baseline (pre-treatment), up to eight weeks (post-treatment)
Parenting Stress Index-Short Form, 4th Edition (PSI4-SF)
Time frame: Baseline (pre-treatment), up to eight weeks (post-treatment)
Child Oral and Motor Proficiency Scale (ChOMPS)
Time frame: Baseline (pre-treatment), up to eight weeks (post-treatment)
Child Behavior Checklist (CBCL) for ages 1 1/2 to 5 years old
Time frame: Baseline (pre-treatment), up to eight weeks (post-treatment)
Child Behavior Checklist (CBCL) for ages 6-10 years old
Time frame: Baseline (pre-treatment), up to eight weeks (post-treatment)
Change in Body Weight
Time frame: Baseline (pre-treatment), up to eight weeks (post-treatment)
Change in Height
Time frame: Baseline (pre-treatment), up to eight weeks (post-treatment)
Change in Mid-upper arm circumference
Time frame: Baseline (pre-treatment), up to eight weeks (post-treatment)
Change in Hand Grip Strength
Time frame: Baseline (pre-treatment), up to eight weeks (post-treatment)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Natalie Morris, MS principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Desensitization with flipped spoon and flipped spoon in people with Feeding Disorder, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline frequency of gags at 8 weeks, or when treatment goals are met (time frame: Baseline, up to eight weeks after first treatment visit). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2019.