Feeding and Eating Disorders of ChildhoodNCT02119910
Technology-supported Behavioral Feeding Intervention
A study testing Technology Supported Manual in people with Feeding and Eating Disorders of Childhood, run by Emory University at 1 site in United States.
Trial summary
This investigation proposes to examine the effectiveness of a technology supported treatment manual for pediatric feeding disorders. Children with pediatric feeding disorders display intense avoidance behaviors (e.g., crying, tantrums, and disruptions) that prevent appropriate nutritional intake during meals and lead… Read more about this study
- Who is it for?
- Ages 12 months to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Feeding and Eating Disorders of Childhood
- What is being tested?
- Technology Supported Manual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Mar 2015
- 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 12 months to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Participants must demonstrate failure to meet appropriate nutritional and/or energy needs based on DSM-V criteria (American Psychiatric Association, 2013) for Avoidant/Restrictive Food Intake Disorder, focusing exclusively on children with dependence on enteral feeding or oral supplementation with a nutritionally complete formula. Specifically, participants must have a history of food refusal as evidenced by tube, formula, or bottle dependence, receiving at least 50% of their nutritional needs from this method of intake. In order to be considered eligible, participants will need to meet the following inclusion criteria: 1) Present with partial food refusal as evidenced by greater than 50% of caloric needs met by bottle, formula, or tube feedings; 2) Have a medical history significant for an organic factor (e.g., gastrointestinal issues) which precipitated or played a role in the development of feeding concern; 3) Fall between the ages of 12 months and 6 years, which will ensure a sample of children appropriate for the introduction of solid food; and 4) Patients must be English literate.
Who cannot join
- The following will be considered ineligible to participate in the study: 1) Patients with active medical diagnoses requiring hospitalization or significant oversight from a physician; and 2) Patients with active medical, structural, or functional limitations preventing safe oral intake of pureed foods (e.g., aspiration, upper airway obstruction).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development of a Manual-based, Technology-supported, Behavioral Feeding Intervention
This investigation proposes to examine the effectiveness of a technology supported treatment manual for pediatric feeding disorders. Children with pediatric feeding disorders display intense avoidance behaviors (e.g., crying, tantrums, and disruptions) that prevent appropriate nutritional intake during meals and lead to a number of negative and potentially life threatening medical outcomes, including chronic malnutrition, growth retardation, and placement of a feeding tube. To date, behavioral intervention involving extinction-based procedures represents the only treatment for pediatric feeding disorders supported by research to improve mealtime behaviors. Due to the chronic and extreme nature of food refusal, treatment typically requires intensive, daily intervention conducted at highly specialized clinics to improve feeding behaviors. The cost and duration of intervention can total as much as $60,000 per child requiring up to 6 to 8 weeks, respectively. The potential for serious consequences associated with chronic food refusal, combined with the high cost of treatment, intensifies the need to identify means to disseminate effective treatment approaches to the broader community of healthcare providers.
The proposed study represents the first attempt to systematically investigate the use of a treatment manual to address chronic food aversion through a randomized, waitlist control trial in children treated at the Marcus Autism Center's Pediatrics Feeding Disorders Program. This study will involve a total of 20 participants randomly assigned to experimental conditions: technology supported treatment manual or waitlist control group (10 in each group). Children assigned to the waitlist control group will receive the technology supported treatment manual after the specified time on the waitlist. All participants will receive the same behavioral protocol involving three treatment sessions per day (45 minutes in length), for a total of 15 sessions across five consecutive days. Data will be collected on feeding behaviors during each treatment session and at follow-up using trained observers to collect data on mealtime behaviors, including acceptance, swallowing, disruption, expulsion, and grams consumed. This type of data collection and treatment is standard practice in the feeding disorders program; however, the use of a touch screen application for data capture with integrated manual is novel to this project.
- Being tested
- Technology Supported Manual
- Keywords
- pediatric feeding disorders, behavioral intervention, treatment manual, feeding, food refusal, diet
- Medical subject headings
- Feeding and Eating Disorders of Childhood
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Technology Supported ManualBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Technology Supported Manual | Experimental | Participants in this arm will receive behavioral intervention for a period of 5 consecutive days. A total of 3, 45-minute meals will be held at regularly scheduled times (e.g., 9:00 a.m., 10:30 a.m., and 12:00 p.m.) each day for a total of 15 meals throughout treatment. Receives: Behavioral: Technology Supported Manual |
| Waitlist | No intervention | Participants will serve as the control condition. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mealtime Behaviors
Behavioral ratings will document such variables as acceptance, mouth clean, combined inappropriate behavior, expulsions, and grams consumed. Data on each of these variables will be collected on computers using an event-recording program built into the computerized manual. Acceptance will be scored when a child takes one or more bites independently every 30 seconds or allows the entire bite of food to be deposited in his/her mouth within 5 seconds of the initial presentation. A mouth clean will be scored when the child swallows all the food within 30 seconds. Data will also be collected on combined inappropriate mealtime behaviors, which are defined as head turns and disruptions. Expulsions will be defined as the presence of food greater than the size of a pea visible outside the mouth after the bite enters the child's mouth.
Measured: 1 week
Secondary outcomes (1)
Parenting Stress Index- Short Form
The PSI-SF is a screening instrument designed to provide an indication of the overall level of parenting stress an individual is experiencing through self-report. It is comprised of three subscales of 12 items each: Parental Distress (PD), Parent-Child Dysfunctional Interaction (P-CDI), and Difficult Child (DC). It has been used in pediatric samples and has exhibited high internal reliability.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2014 (estimated)
- Study startJan 2014
- Primary completionDec 2014
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Feeding and Eating Disorders of ChildhoodStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William Sharp, PhD, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02119910
- Sponsor's protocol ID
- IRB00072609
- Status last verified
- Mar 2015
- First submitted
- 24 Mar 2014
- Last updated
- 17 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Manual-based, Technology-supported, Behavioral Feeding Intervention
- ClinicalTrials.gov ID
- NCT02119910
- Acronym / sponsor ID
- IRB00072609
- Keywords
- pediatric feeding disorders, behavioral intervention, treatment manual, feeding, food refusal, diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 22 Apr 2014 (estimated)
- 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.
This investigation proposes to examine the effectiveness of a technology supported treatment manual for pediatric feeding disorders. Children with pediatric feeding disorders display intense avoidance behaviors (e.g., crying, tantrums, and disruptions) that prevent appropriate nutritional intake during meals and lead to a number of negative and potentially life threatening medical outcomes, including chronic malnutrition, growth retardation, and placement of a feeding tube. To date, behavioral intervention involving extinction-based procedures represents the only treatment for pediatric feeding disorders supported by research to improve mealtime behaviors. Due to the chronic and extreme nature of food refusal, treatment typically requires intensive, daily intervention conducted at highly specialized clinics to improve feeding behaviors. The cost and duration of intervention can total as much as $60,000 per child requiring up to 6 to 8 weeks, respectively. The potential for serious consequences associated with chronic food refusal, combined with the high cost of treatment, intensifies the need to identify means to disseminate effective treatment approaches to the broader community of healthcare providers.
The proposed study represents the first attempt to systematically investigate the use of a treatment manual to address chronic food aversion through a randomized, waitlist control trial in children treated at the Marcus Autism Center's Pediatrics Feeding Disorders Program. This study will involve a total of 20 participants randomly assigned to experimental conditions: technology supported treatment manual or waitlist control group (10 in each group). Children assigned to the waitlist control group will receive the technology supported treatment manual after the specified time on the waitlist. All participants will receive the same behavioral protocol involving three treatment sessions per day (45 minutes in length), for a total of 15 sessions across five consecutive days. Data will be collected on feeding behaviors during each treatment session and at follow-up using trained observers to collect data on mealtime behaviors, including acceptance, swallowing, disruption, expulsion, and grams consumed. This type of data collection and treatment is standard practice in the feeding disorders program; however, the use of a touch screen application for data capture with integrated manual is novel to this project.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Technology Supported Manual | Experimental | Behavioral: Technology Supported ManualParticipants in this arm will receive behavioral intervention for a period of 5 consecutive days. A total of 3, 45-minute meals will be held at regularly scheduled times (e.g., 9:00 a.m., 10:30 a.m., and 12:00 p.m.) each day for a total of 15 meals throughout treatment. |
| Waitlist | No intervention | –Participants will serve as the control condition. |
Who may qualify
- Ages
- 12 months to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Participants must demonstrate failure to meet appropriate nutritional and/or energy needs based on DSM-V criteria (American Psychiatric Association, 2013) for Avoidant/Restrictive Food Intake Disorder, focusing exclusively on children with dependence on enteral feeding or oral supplementation with a nutritionally complete formula. Specifically, participants must have a history of food refusal as evidenced by tube, formula, or bottle dependence, receiving at least 50% of their nutritional needs from this method of intake. In order to be considered eligible, participants will need to meet the following inclusion criteria: 1) Present with partial food refusal as evidenced by greater than 50% of caloric needs met by bottle, formula, or tube feedings; 2) Have a medical history significant for an organic factor (e.g., gastrointestinal issues) which precipitated or played a role in the development of feeding concern; 3) Fall between the ages of 12 months and 6 years, which will ensure a sample of children appropriate for the introduction of solid food; and 4) Patients must be English literate.
Key exclusion criteria (1 listed)
- The following will be considered ineligible to participate in the study: 1) Patients with active medical diagnoses requiring hospitalization or significant oversight from a physician; and 2) Patients with active medical, structural, or functional limitations preventing safe oral intake of pureed foods (e.g., aspiration, upper airway obstruction).
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 |
|---|---|---|
| Technology Supported Manual | Behavioural | Technology Supported Manual |
Primary outcome
Mealtime Behaviors
Time frame: 1 week
Behavioral ratings will document such variables as acceptance, mouth clean, combined inappropriate behavior, expulsions, and grams consumed. Data on each of these variables will be collected on computers using an event-recording program built into the computerized manual. Acceptance will be scored when a child takes one or more bites independently every 30 seconds or allows the entire bite of food to be deposited in his/her mouth within 5 seconds of the initial presentation. A mouth clean will be scored when the child swallows all the food within 30 seconds. Data will also be collected on combined inappropriate mealtime behaviors, which are defined as head turns and disruptions. Expulsions will be defined as the presence of food greater than the size of a pea visible outside the mouth after the bite enters the child's mouth.
1 secondary outcome
Parenting Stress Index- Short Form
Time frame: 1 month
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 17 Mar 2015.
Related trials for Feeding and Eating Disorders of Childhood
RecruitingObservational study
Gut Microbiota Changes in Children Receiving Exclusive Enteral Nutrition With Compleat® Paediatric
Feeding and Eating Disorders of Childhood, Enteral Nutrition Dependence
Not yet recruitingObservational study
Exploring Lived Experiences of Families of Children With Spinal Muscular Atrophy(SMA) Type 1 Regarding Feeding and Communication
Spinal Muscular Atrophy 1
Enrolling by invitationObservational study
CHAMP App Feeding Difficulties Repository
Feeding and Eating Disorders of Childhood, Gastrostomy
Active, not recruiting
Childhood Obesity - Prevention of Diabetes Through Changed Eating Patterns
Childhood Obesity, Overweight and Obesity
Not yet recruiting
Effectiveness of a 10-week Multicomponent Intervention Combined With Parent Education on Binge Eating Behavior in Children and Adolescents
Binge Eating Disorder, Binge Eating
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Technology Supported Manual in people with Feeding and Eating Disorders of Childhood, run by Emory University 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 1 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 17 Mar 2015. 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. 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?
Mealtime Behaviors (time frame: 1 week). 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 17 Mar 2015.