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出境医 / 临床实验 / Project LEaH: Learning to Eat at Home

Project LEaH: Learning to Eat at Home

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

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Feeding Behavior Behavioral: Parent coaching Not Applicable

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.
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
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.
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : August 7, 2018
Actual Primary Completion Date : April 23, 2020
Actual Study Completion Date : July 23, 2020
Arms and Interventions
Arm Intervention/treatment
Experimental: Feeding Challenges
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.
 Behavioral: Parent coaching
Parents will be coached to implement behavioural strategies to address factors which are contributing to difficult mealtime behaviours and feeding challenges.
Outcome Measures
Primary Outcome Measures :
  1. Parent Treatment Adherence Scale [ Time Frame: 12 weeks ]
    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.

  2. Parent Satisfaction Scale [ Time Frame: 12 weeks ]
    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).

  3. Treatment Fidelity Scale [ Time Frame: 12 weeks ]
    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 :
  1. Change in number of foods eaten from baseline to week 12 (or end of intervention whichever comes first) [ Time Frame: 12 weeks ]
    Number of foods eaten will be captured by a 1 day food diary at baseline and week 12

  2. Change from baseline in performance scores on the COPM scale at 12 weeks [ Time Frame: 12 weeks ]
    Change in participants performance on a single tasks from baseline to 12 weeks (or end of intervention whichever comes first)


Eligibility Criteria
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Ages Eligible for Study:   2 Years to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Locations
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Canada, Ontario
Holland Bloorview Kids Rehabilitation Hospital
Toronto, Ontario, Canada, M4G 1R8
Sponsors and Collaborators
Holland Bloorview Kids Rehabilitation Hospital
Investigators
Layout table for investigator information
Principal Investigator: Sharon C Smile, MBBS,DM,MSc Holland Bloorview Kids Rehabilitation Hospital
Tracking Information
First Submitted Date  ICMJE June 11, 2019
First Posted Date  ICMJE June 20, 2019
Last Update Posted Date November 20, 2020
Actual Study Start Date  ICMJE August 7, 2018
Actual Primary Completion Date April 23, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 18, 2019)
  • Parent Treatment Adherence Scale [ Time Frame: 12 weeks ]
    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 [ Time Frame: 12 weeks ]
    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 [ Time Frame: 12 weeks ]
    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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 18, 2019)
  • Change in number of foods eaten from baseline to week 12 (or end of intervention whichever comes first) [ Time Frame: 12 weeks ]
    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 [ Time Frame: 12 weeks ]
    Change in participants performance on a single tasks from baseline to 12 weeks (or end of intervention whichever comes first)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Project LEaH: Learning to Eat at Home
Official Title  ICMJE Delivering Specialty Care Access Through Use of an Innovative Telehealth-home Based Intervention Feeding Program (Telefeeding) to Address Food Selectivity in Autism Spectrum Disorder
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
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.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Autism Spectrum Disorder
  • Feeding Behavior
Intervention  ICMJE Behavioral: Parent coaching
Parents will be coached to implement behavioural strategies to address factors which are contributing to difficult mealtime behaviours and feeding challenges.
Study Arms  ICMJE Experimental: Feeding Challenges
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: Behavioral: Parent coaching
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 18, 2020) 		15
Original Estimated Enrollment  ICMJE
 (submitted: June 18, 2019) 		10
Actual Study Completion Date  ICMJE July 23, 2020
Actual Primary Completion Date April 23, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 5 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03992118
Other Study ID Numbers  ICMJE 18-786
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Sharon Smile, Holland Bloorview Kids Rehabilitation Hospital
Study Sponsor  ICMJE Holland Bloorview Kids Rehabilitation Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sharon C Smile, MBBS,DM,MSc Holland Bloorview Kids Rehabilitation Hospital
PRS Account Holland Bloorview Kids Rehabilitation Hospital
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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