Consent and enrollment
First the study coordinator will complete a detailed informed consent process obtaining
written consent via REDCap e-consent over Zoom video conferencing with the parent,
detailing the intervention and documenting the parent's consent to participate and the
parent's permission for the child to participate.
Consent will be obtained to review prior feeding evaluations including clinical and
fluoroscopic swallow studies, view early intervention evaluations if available, contact
the primary physician or subspecialty physicians for clarification of medical issues, and
to collaborate with existing therapists as needed. During the initial video conferencing
call the Principal Investigator (PI) will conduct a medical and feeding history with the
parent to determine appropriateness for the intervention and create context for the team
to prepare for the child's in-home enrollment visit.
There are some patients that will be enrolled but determined not appropriate to proceed
with the feeding intervention. At the end of the video session, the PI will determine or
the team may briefly discuss if the child is appropriate for increasing oral experiences
and feeding. The investigators expect that a minority of children will not have safe gag
reflexes for starting to feed by mouth. For these children, the investigators will defer
their enrollment in the study until a potential later date and plan to re-assess after a
period of time.
In addition, the investigators will request access to prior feeding evaluations including
clinical and fluoroscopic swallow studies. It is important that the investigators are
entering as a care team as informed as possible about the child's medical issues which
may impede safe advancement of feeding. Identifiable information (Name/Date of Birth)
will be used in gaining access to the swallow studies. If a parent wishes not share these
prior records, they will not be enrolled in the study. The investigators will also ask
for any early intervention evaluations that are available.
After their conversation with the PI, if they are determined to be appropriate for the
intervention, parents will complete a demographic survey via REDCap. The survey will
contain items related to characteristics about themselves and their family.
Initial Assessment
The interdisciplinary study intervention team (Developmental and Behavioral Pediatrician,
Speech Therapist, Occupational Therapist, Registered Dietitian, and Study Coordinator)
will participate in-person in the home enrollment visit. In some cases a team member may
join remotely, however the majority of the interdisciplinary team will be in-home and
in-person.
The Speech Therapist and Occupational Therapist will complete a comprehensive feeding
assessment, which will include a combination of validated surveys, structured interviews,
and physical exams. Examples of standardized measures include: The Feeding and Swallowing
Impact Survey, which measures caregiver issues related to feeding (e.g. "I worry that my
child will never eat or drink like other children.") and the Pediatric Eating Assessment
Toll (PediEAT) survey which includes questions related to feeding difficulties. The
registered dietitian will take a detailed dietary history to obtain a total daily calorie
count and determine what percent is currently oral versus tube-fed. The Speech Therapist
or Occupational Therapist will complete the Children's Eating and Drinking Activity Scale
(CEDAS), which describes children's dependence on tube feeding and ability to take food
orally on a scale of 1-6. If the child is already oral feeding, the team will observe an
oral feeding session between the parent and child. After the feeding session, or if one
does not occur, the speech and occupational therapist will assess the child's readiness
for oral feeding and aspiration risk, and determine the degree of sensory and/or oral
aversion. The registered dietitian will be complete an assessment over Zoom conferencing
with the study team. Additional data to be collected includes: height and weight, and mid
arm circumference. Internet connectivity and access to a device (computer/iPad/smart
phone) for future virtual visits will be checked and as needed, an iPad with internet
service provided for the family during the study.
Each family will then be randomized into either (1) a control group who participates in a
weekly group virtual mealtime feeding session only, and (2) a treatment group who
participates in a weekly group virtual mealtime feeding session and also individual
interdisciplinary virtual feeding therapies which will occur at least biweekly.
Intervention
Intervention Group: All participants in the intervention group will be invited to weekly
virtual group therapy mealtime sessions with the Speech-Language Pathologist and other
participants in the intervention group. Additionally, families will engage in virtual
therapy sessions at least biweekly focused on individualized goals informed by the
expertise of the study team and published expert programs. Therapies intervention group
participants are already receiving or who begin to receive during the study period will
not be stopped during this intervention and the investigators will coordinate therapeutic
programs with existing therapists. Based upon the investigators' prior work with this
population, the investigators anticipate that all intervention subjects will benefit from
sessions with the speech language pathologist/feeding therapist and about half will have
sensory issues related to feeding and will benefit from joint sessions with the
occupational therapist; each therapist will be utilized as needed. They will consult with
the registered dietitian and Developmental and Behavioral Pediatrician as needed. The
feeding therapist will track the child's acceptability of food presentations over time.
Scales for weight monitoring will be shared with these families for tracking the child's
weight accurately during the intervention. Collaboration with the child's
gastroenterologist, pediatrician, and/or community dietitian or feeding therapist will be
arranged as needed to coordinate care outside of the regular meetings with the family.
An expert team (speech therapist, occupational therapist, developmental and behavioral
pediatrician, and registered dietitian) will complete all assessments and together create
individualized therapy plans. This study will examine three main outcomes through
standardized assessments at enrollment, 3-month, 6-month, 9-month, and 12-month
intervals. (1) Children's Eating and Drinking Activity Scale (CEDAS); (2) The Feeding and
Swallowing Impact Survey (FS-IS); (3) Percentage of oral intake; and (4) PediEAT. An
updated dietary history, and the pace of feeding will also be evaluated at the same time
points listed above. Parent engagement for the control group will be gauged based on
attendance frequency.
For children who are not feeding by mouth at all at the time of enrollment, initial
therapies may include working on the muscle movements of eating by stimulating the oral
cavity. There may also be strategies engaged to reduce aversions to eating, for example
playing with foods and utensils during mealtime (if toddler-age) or tolerating a pacifier
or bottle nipple (if infant). For children who are oral feeding at time of enrollment,
the interdisciplinary team will make a determination of how to advance feeding according
to best standard practice. Strategies they may engage will include hunger provocation,
adjusting tube feed timing/quantity/composition, and others. Intervention group
participants will also be invited to a weekly virtual group therapy mealtime session.
Control Group. All participants in the control group will be invited to a weekly virtual
group therapy mealtime session with other enrolled control group participants and a
speech therapist who is not involved with the intervention. During this informal session,
families will have the opportunity to meet other children with feeding tubes and their
parents. The investigators will assess level of engagement (frequency of participation)
and parental experience at interval assessments. Therapies research participants are
already receiving or who begin to receive during the study period (early intervention
community therapies, center-based therapies) will not be stopped during this
intervention. Data will be collected on the frequency of these standard of care
therapies. The assessments used for the control group will be the same assessments as the
intervention group and will include the Speech Therapy Assessment; Occupational Therapy
Assessment; and PediEAT.
Exit Assessment.
Upon completing the virtual and dietary assessment at 3, 6, and 9 months a final exit
home visit assessment will take place at 1 year. The final exit visit will include a
repeated CEDAS, FS-IS, PediEAT, parent exit survey, Occupational Therapist Assessment,
and Speech Therapy Assessment. During the final in-home assessment after 12 months of
study participation, the PI will refer all children who still require therapies for
additional therapies or subspecialty appointments.
Duration:
Participants will be each involved in the study for 1 year. The investigators anticipate
the full trial to last 3 years.
Parents will participate in the following:
- An enrollment session which will occur over Zoom video conferencing following the
consent process. This will include a medical and feeding history which will be taken
by the PI in order to determine appropriateness for the intervention. This will be
followed by a brief REDCap demographic survey either emailed to the family or
completed over zoom with the study coordinator.
- Introduction and home enrollment visit, which will include height and weight of the
child, as well as the Feeding and Swallowing Impact Survey (FS-IS), the Children's
Eating and Drinking Activity Scale (CEDAS), and the PediEAT. Parents will also
provide the registered dietitian with a detailed dietary history and therapists will
complete the complete the Speech Assessment tool and Occupational Therapist
assessment tool in REDCap. These tools include questions related to the child's
frequency of oral intake, reaction to oral stimulation and feeding and medical
history.
- The program will then include:
- Weekly virtual mealtime group with therapists for both control and intervention
group. After each mealtime group session parents will be asked to complete a
brief survey about what they learned and any topics that they would like
covered in the next session.
- Biweekly virtual therapies with a Speech Therapist and Occupational Therapist
for the intervention group. After each therapy session parents will be asked to
complete a brief survey about what they learned and any topics that they would
like covered in the next session.
- Anticipated intermittent consultation with a Registered Dietitian for the
intervention group
- As needed consultation with Developmental and Behavioral Pediatrician for the
intervention group
- Parents will be asked to complete virtual oral feeding and dietary assessments
including the FS-IS at 3, 6, and 9 months of study enrollment.
- An exit home visit will take place at 1 year with repeated parent survey measures
including the FS-IS, and selected repeated questions from the enrollment survey.
