Project LEaH: Learning to Eat at Home

Not Applicable

Completed

• Conditions: Feeding Behavior; Autism Spectrum Disorder
• Interventions: Behavioral: Parent coaching

• Registration Number: NCT03992118
• Lead Sponsor: Holland Bloorview Kids Rehabilitation Hospital

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 Timeline

• Study Start: 2018-08-07
• Study First Submitted: 2019-06-11
• Study First Submitted QC: 2019-06-18
• Study First Posted: 2019-06-20
• Primary Completion: 2020-04-23
• Study Completion: 2020-07-23
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-18
• Last Update Posted: 2020-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Feeding Challenges	Parent coaching	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.

Primary Outcome Measures

Name	Time	Method
Parent Satisfaction Scale	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	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.
Parent Treatment Adherence Scale	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.

Secondary Outcome Measures

Name	Time	Method
Change in number of foods eaten from baseline to week 12 (or end of intervention whichever comes first)	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	12 weeks	Change in participants performance on a single tasks from baseline to 12 weeks (or end of intervention whichever comes first)

Trial Locations

Locations (1)

Holland Bloorview Kids Rehabilitation Hospital; 🇨🇦 Toronto, Ontario, Canada