Assistive Technology for Children on Tube Feeding

N/A

Recruiting

Led By Sarah Sobotka, MD, MSCP

Research Sponsored by University of Chicago

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Under 3 years of age

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 3 month, 6 month and exit at 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to test an intervention program for children with feeding tubes and tracheostomies to help them transition to oral feeding. The program combines in-home assessments with virtual therapies led by a team

Who is the study for?

This trial is for children with feeding tubes and tracheostomies who need help transitioning to oral feeding. It's designed for those who could benefit from an interdisciplinary approach involving in-home assessments and virtual therapies by a team of specialists.

What is being tested?

The study tests a hybrid intervention combining in-person and virtual support to improve oral feeding. It includes sessions with occupational therapists, speech/language pathologists, dietitians, family liaisons, and a project leader specialized in pediatric care.

What are the potential side effects?

Since the therapy techniques are standard care within professional practice parameters, significant side effects aren't anticipated. However, as this method involves novel virtual elements being researched, unexpected challenges may arise.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am under 3 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 3 month, 6 month and exit at 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 3 month, 6 month and exit at 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3 month, 6 month and exit at 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in percentage of oral calories

Secondary study objectives

Caregiver self-efficacy

Change in Oral Feeding

Increased frequency of feeding trials

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Intervention groupExperimental Treatment2 Interventions

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. Individualized programs will include virtual sessions with the occupational therapist, speech therapist, or combined therapies. The team will consult with the registered dietitian and Developmental and Behavioral Pediatrician as needed.

Group II: Control groupExperimental Treatment1 Intervention

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.

0 / 1Eligibility criteria met