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Project LEaH: Learning to Eat at Home

Primary Purpose

Autism Spectrum Disorder, Feeding Behavior

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Parent coaching
Sponsored by
Holland Bloorview Kids Rehabilitation Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder

Eligibility Criteria

2 Years - 5 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Holland Bloorview Kids Rehabilitation Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Feeding Challenges

Arm Description

Parents will be coached to implement strategies to address factors contributing to feeding challenges based on a multidisciplinary assessment using the medico-oral-behaviour-sensory-environment (MOBSE) approach.

Outcomes

Primary Outcome Measures

Parent Treatment Adherence Scale
Parent Treatment Adherence scale will be used to rate parent engagement and understanding of in session materials. The scale will be completed by the therapists at the end of each intervention session to rate parent engagement and understanding of instructions and assignment on a three point likert scale.
Parent Satisfaction Scale
A questionnaire was developed for the study to obtain parent feedback at week 12 on the quality of the block of intervention. Questions rated the length of the sessions, number of sessions, the usefulness of teaching tools (for e.g. homework), and participants confidence in handling future feeding challenges. Scores range from 0(strongly disagree) to 4 (strongly agree).
Treatment Fidelity Scale
A treatment fidelity checklist was developed for this study. Treatment fidelity will be measured using a questionnaire to rate if the intervention session goals were met during the session. This will be done using a 3 point likert scale. After completion of each session the therapists will rate themselves as: 0= Goal was not achieved; 1- Goal was partially achieved; 2= Goal was fully achieved for each treatment goal for that session.

Secondary Outcome Measures

Change in number of foods eaten from baseline to week 12 (or end of intervention whichever comes first)
Number of foods eaten will be captured by a 1 day food diary at baseline and week 12
Change from baseline in performance scores on the COPM scale at 12 weeks
Change in participants performance on a single tasks from baseline to 12 weeks (or end of intervention whichever comes first)

Full Information

First Posted
June 11, 2019
Last Updated
November 18, 2020
Sponsor
Holland Bloorview Kids Rehabilitation Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03992118
Brief Title
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

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
August 7, 2018 (Actual)
Primary Completion Date
April 23, 2020 (Actual)
Study Completion Date
July 23, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Holland Bloorview Kids Rehabilitation Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder, Feeding Behavior

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Feeding Challenges
Arm Type
Experimental
Arm Description
Parents will be coached to implement strategies to address factors contributing to feeding challenges based on a multidisciplinary assessment using the medico-oral-behaviour-sensory-environment (MOBSE) approach.
Intervention Type
Behavioral
Intervention Name(s)
Parent coaching
Intervention Description
Parents will be coached to implement behavioural strategies to address factors which are contributing to difficult mealtime behaviours and feeding challenges.
Primary Outcome Measure Information:
Title
Parent Treatment Adherence Scale
Description
Parent Treatment Adherence scale will be used to rate parent engagement and understanding of in session materials. The scale will be completed by the therapists at the end of each intervention session to rate parent engagement and understanding of instructions and assignment on a three point likert scale.
Time Frame
12 weeks
Title
Parent Satisfaction Scale
Description
A questionnaire was developed for the study to obtain parent feedback at week 12 on the quality of the block of intervention. Questions rated the length of the sessions, number of sessions, the usefulness of teaching tools (for e.g. homework), and participants confidence in handling future feeding challenges. Scores range from 0(strongly disagree) to 4 (strongly agree).
Time Frame
12 weeks
Title
Treatment Fidelity Scale
Description
A treatment fidelity checklist was developed for this study. Treatment fidelity will be measured using a questionnaire to rate if the intervention session goals were met during the session. This will be done using a 3 point likert scale. After completion of each session the therapists will rate themselves as: 0= Goal was not achieved; 1- Goal was partially achieved; 2= Goal was fully achieved for each treatment goal for that session.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change in number of foods eaten from baseline to week 12 (or end of intervention whichever comes first)
Description
Number of foods eaten will be captured by a 1 day food diary at baseline and week 12
Time Frame
12 weeks
Title
Change from baseline in performance scores on the COPM scale at 12 weeks
Description
Change in participants performance on a single tasks from baseline to 12 weeks (or end of intervention whichever comes first)
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sharon C Smile, MBBS,DM,MSc
Organizational Affiliation
Holland Bloorview Kids Rehabilitation Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Holland Bloorview Kids Rehabilitation Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4G 1R8
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Project LEaH: Learning to Eat at Home

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