Autism Spectrum DisorderNCT03992118
Project LEaH: Learning to Eat at Home
A study testing Parent coaching in people with Autism Spectrum Disorder and Feeding Behavior, run by Holland Bloorview Kids Rehabilitation Hospital at 1 site in Canada.
Trial summary
The investigators are trying to determine if delivery a feeding intervention program using videoconferencing technology is feasible. Read more about this study
- Who is it for?
- Ages 2 to 5 years
- Conditions the study is for
- Autism Spectrum Disorder, Feeding Behavior
- What is being tested?
- Parent coaching
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- 7 Aug 2018to 23 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Show all 10Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Holland Bloorview Kids Rehabilitation Hospital
Toronto, Ontario, M4G 1R8
About this study
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
The investigators are trying to determine if delivery a feeding intervention program using videoconferencing technology is feasible.
Read the 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.
- Conditions
- Autism Spectrum Disorder, Feeding Behavior
- Being tested
- Parent coaching
- Medical subject headings
- Autism Spectrum Disorder, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parent coachingBehavioural
Parents will be coached to implement behavioural strategies to address factors which are contributing to difficult mealtime behaviours and feeding challenges.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Parent coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: 12 weeks
Secondary outcomes (2)
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
Measured: 12 weeks
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)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2019
- Study start7 Aug 2018
- Primary completion23 Apr 2020
- Study completion23 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Holland Bloorview Kids Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sharon Smile, Holland Bloorview Kids Rehabilitation Hospital
- Investigators
- Sharon C Smile, MBBS,DM,MSc, Principal investigator, Holland Bloorview Kids Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03992118
- Sponsor's protocol ID
- 18-786
- Status last verified
- Nov 2020
- First submitted
- 11 Jun 2019
- Last updated
- 20 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03992118
- Acronym / sponsor ID
- 18-786
- Conditions
- Autism Spectrum Disorder, Feeding Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Holland Bloorview Kids Rehabilitation HospitalUniversity, hospital or other
- Study start
- 7 Aug 2018 (actual)
- Primary completion
- 23 Apr 2020 (actual)
- Study completion
- 23 Jul 2020 (actual)
- First posted
- 20 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Feeding Challenges | Experimental | Behavioral: Parent coachingParents 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. |
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (8 listed)
- Age: > 6 year of age (rationale being most children will be enrolled in school during the week thus not available for intervention services).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parent coachingParents will be coached to implement behavioural strategies to address factors which are contributing to difficult mealtime behaviours and feeding challenges. | Behavioural | Feeding Challenges |
Primary outcome
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.
2 secondary outcomes
Change in number of foods eaten from baseline to week 12 (or end of intervention whichever comes first)
Time frame: 12 weeks
Change from baseline in performance scores on the COPM scale at 12 weeks
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sharon C Smile, MBBS,DM,MSc principal investigator
Holland Bloorview Kids Rehabilitation Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parent coaching in people with Autism Spectrum Disorder and Feeding Behavior, run by Holland Bloorview Kids Rehabilitation Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parent Treatment Adherence Scale (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2020.