Let's E.A.T.! (Eating With Assistive Technology): An Intervention to Support Children With Feeding Tubes and Tracheostomies

Summary

The overall objective of this proposal is to test an interdisciplinary intervention to support the transition to oral feeding for children with feeding tubes and tracheostomies. The investigators' model which combines in-home clinical assessments with virtual therapies may maximize the impact of expert interventionists. The investigators' central hypothesis is that children with feeding tubes and tracheostomies will have greater success than a control group when enrolled in a hybrid in-person/virtual intervention including: (1) a coordinated feeding team with an occupational therapist, speech/language pathologist, and registered dietitian; (2) family liaison study coordinators who are poised to support the family through personal experience; (3) a project leader who is a Developmental Behavioral Pediatrician with expertise in children with tracheostomies. The overall objective of this proposal is to test this intervention to increase oral feeding in children with feeding tubes and tracheostomies. To pursue this objective, the investigators propose the following aims:

Specific Aim 1: Children enrolled in the intervention group will have improved caregiver self-efficacy and reduced worry related to feeding as determined by The Feeding and Swallowing Impact Survey at the end of a 1-year intervention.

Specific Aim 2: Children enrolled in the intervention group will have increased oral vs. tube-fed calories and reduced dependence on feeding tubes as determined by detailed dietary histories and The Children's Eating and Drinking Activity Scale (CEDAS) at the end of a 1-year intervention.

The investigators' intervention will determine if a tertiary center of expertise can use a combination of home assessments and virtual interventions to address critical feeding needs for children with tracheostomies. Future clinicians could refer patients to the investigators' center instead of relying on community therapists, who rarely exist.

The weekly feeding group sessions as well as the administration of the therapies in a virtual format are research-related. While the therapy techniques implemented during the study are standard of care and within the practice parameters of the practitioners involved, the use of them in a virtual format are novel and should be considered research-related.

Conditions

• Feeding Tube
• Children With Medical Complexity
• Tracheostomy
• Feeding Disorder, Infancy or Early Childhood

Interventions

OTHER

Tube weaning therapy intervention

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 individual 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. The Speech Therapist and Occupational Therapist will be utilized as needed for the child's individualized care plan. They will consult with the registered dietitian and Developmental and Behavioral Pediatrician as needed.

OTHER

Feeding 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 Pediatric Eating Assessment Toll.

Sponsors & Collaborators

• The Gerber Foundation

  collaborator OTHER

• University of Chicago

  lead OTHER

Principal Investigators

• Sarah Sobotka, MD, MSCP · University of Chicago

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Max Age

3 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-07-08

Primary Completion

2027-07-07

Completion

2027-07-07

Countries

• United States

Study Locations