Clinical trial NCT03992118: Project LEaH: Learning to Eat at Home
Official title: Delivering Specialty Care Access Through Use of an Innovative Telehealth-home Based Intervention Feeding Program (Telefeeding) to Address Food Selectivity in Autism Spectrum Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Feeding Behavior
Lead sponsor: Holland Bloorview Kids Rehabilitation Hospital
Sponsor class: OTHER
First posted: 2019-06-20
Enrollment: 15
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Participants will be recruited to participate in a multidisciplinary feeding assessment, after which an intervention plan will be developed to address the participants feeding challenges.
Primary purpose: TREATMENT

Brief summary: The investigators are trying to determine if delivery a feeding intervention program using videoconferencing technology is feasible.

Detailed description: The investigators hope to recruit 10 participants who have a diagnosis of autism spectrum disorder and food selectivity. A Multidisciplinary feeding assessment will be conducted and factors which contribute to the participant's feeding challenges will be identified. Treatment goals will be identified using the Canadian Occupational Performance Measure (COPM). Intervention geared to address the goals identified by parents will be delivered by the clinician(s) via videoconferencing. Participants will participate in up to 12 weekly 1hr visits over the study period.

Eligibility criteria: Inclusion Criteria:

* Age: 2-5 years of age
* Diagnosed with Autism Spectrum Disorder
* History of mild to moderate food selectivity
* Access to internet service
* Access to a Windows based laptop with a web camera
* One Parent is available to participate in a 1 hour intervention program within the home environment once per week over a 12 week period.
* English speaking participants
* Parent consents to use of Ontario Telemedicine Network (OTN) technology within in the home.
* Parent is able to use a laptop
* Access to a telephone in order to trouble shoot problems that may arise in setting up OTN technology.

Exclusion Criteria:

* Age: \> 6 year of age (rationale being most children will be enrolled in school during the week thus not available for intervention services).

  * History of severe food selectivity
  * No access to internet service and/or laptop
  * History of dysphagia or other swallowing difficulties
  * Oro-motor abnormalities such as cleft lip and palate, macroglossia
  * Presently has a G-tube insitu
  * Participants on medications that may significantly alter appetite such as stimulants and antipsychotic medications.
  * Currently enrolled in a feeding intervention program.

Primary outcomes:
measure: Parent Treatment Adherence Scale
timeFrame: 12 weeks
measure: Parent Satisfaction Scale
timeFrame: 12 weeks
measure: Treatment Fidelity Scale
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in number of foods eaten from baseline to week 12 (or end of intervention whichever comes first)
timeFrame: 12 weeks
measure: Change from baseline in performance scores on the COPM scale at 12 weeks
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Holland Bloorview Kids Rehabilitation Hospital
state: Ontario
Study officials:
affiliation: Holland Bloorview Kids Rehabilitation Hospital
name: Sharon C Smile, MBBS,DM,MSc
role: PRINCIPAL_INVESTIGATOR
References: