Project LEaH: Learning to Eat at Home

NCT03992118 | Completed

• 1 other identifier: 18-786
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Autism Spectrum Disorder; Feeding Behavior

Outcome Measures

Primary Outcomes (3)

• 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.

  12 weeks

• 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).

  12 weeks

• 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.

  12 weeks

Secondary Outcomes (2)

• Change in number of foods eaten from baseline to week 12 (or end of intervention whichever comes first)

  12 weeks

• Change from baseline in performance scores on the COPM scale at 12 weeks

  12 weeks

Study Arms (1)

Feeding Challenges

EXPERIMENTAL

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

Interventions

Parent coaching BEHAVIORAL

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

Feeding Challenges

Eligibility Criteria

• Age: 2 Years - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Holland Bloorview Kids Rehabilitation Hospital: lead

Study Sites (1)

Holland Bloorview Kids Rehabilitation Hospital

Toronto, Ontario, M4G 1R8, Canada

Location

MeSH Terms

Conditions

Autism Spectrum Disorder; Feeding Behavior

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Behavior, Animal; Behavior

Study Officials

• Sharon C Smile, MBBS,DM,MSc

  Holland Bloorview Kids Rehabilitation Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Developmental Paediatrician

Model Details: 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.

Study Record Dates

• First Submitted: June 11, 2019
• First Posted: June 20, 2019
• Study Start: August 7, 2018
• Primary Completion: April 23, 2020
• Study Completion: July 23, 2020
• Last Updated: November 20, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)