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Completed

NCT Number: NCT03992118

Project LEaH: Learning to Eat at Home

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

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Key information

Conditions

Autism Spectrum Disorder Behavior Behavior, Animal Child Development Disorders, Pervasive Feeding Behavior Mental Disorders Neurodevelopmental Disorders

Age range

2 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Holland Bloorview Kids Rehabilitation Hospital

Toronto, Ontario, M4G 1R8, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Parent coaching

Behavioral

Parents will be coached to implement behavioural strategies to address factors which are contributing to difficult mealtime behaviours and feeding challenges.

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Holland Bloorview Kids Rehabilitation Hospital

Other

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jun 20, 2019
Registry last updated
Nov 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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