Eating DisordersWICFASNCT04812899
Implementation of a Waitlist Intervention and Clinical Care Pathway for Families Awaiting at Eating Disorders Program
A study testing Parental guided self-help version of FBT-pre-recorded videos and readings from the book in people with Eating Disorders, run by McMaster University at 1 site in Canada.
Trial summary
The COVID-19 pandemic has resulted in several challenges in service delivery for the eating disorders program at McMaster Children's Hospital. Long waiting lists prior to the pandemic (6-9 month wait time) have been made worse by an interruption in service during the initial stages of the pandemic. Read more about this study
- Who is it for?
- Ages 7 to 100 years
- Conditions the study is for
- Eating Disorders
- What is being tested?
- Parental guided self-help version of FBT-pre-recorded videos and readings from the book
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 30 Jul 2021to 4 Feb 2022
- 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 7 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Parents of a child or adolescent (6-17 years) with an Eating Disorder.
- Have an access to the internet/computer.
- Have an access to a weigh scale in their home environment
- Have the capacity to write, speak and understand English
Who cannot join
- don't have the capacity to write, speak and understand English
- don't have access to the internet/computer
- don't have a child or adolescent with an eating disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Implementation of a Waitlist Intervention and Clinical Care Pathway for Families Awaiting Services at McMaster Children's Hospital Eating Disorders Program: A Feasibility Study
The COVID-19 pandemic has resulted in several challenges in service delivery for the eating disorders program at McMaster Children's Hospital. Long waiting lists prior to the pandemic (6-9 month wait time) have been made worse by an interruption in service during the initial stages of the pandemic. New routine assessments were placed on hold for many months, while only the most urgently ill children were seen. This, in combination with a dramatic increase in new referrals has resulted in a long waitlist. Now families are waiting 12-18 months for service. The resulting waitlist is now unmanageable and unsafe. Investigators wish to study the implementation of a waitlist intervention which will educate parents on how to start to renourish their children and interrupt eating disordered behaviors. The intervention will consist of a series of educational videos and a book on how to help their children. It is hoped that this intervention can lessen the need for hospitalization and can change the trajectory of symptoms while waiting for service. A clinical care pathway will also be developed to ensure those waiting receive the most appropriate treatment.
Read the detailed description
Investigators would like to study the implementation of an adapted FBT model in which there is no therapist involvement and the intervention is delivered to families on the waitlist of Eating Disorder program at McMaster Children's Hospital. The intervention would involve a series of prerecorded videos and reading material. This, in combination with the development of a clinical care pathway, would help to manage the extraordinary volumes of referrals recently been received. The need to social distance brought on by the pandemic presents the opportunity to consider the value of this waitlist intervention as a structured program for parents who have a child waiting for service. A model such as this could dramatically improve parental abilities to begin to re-feed their children, thereby reducing acuity and time spent in treatment. Similarly, some parents on the waitlist may decide that the proposed treatment model is not suitable after they have received the proposed waitlist intervention, and may wish to seek treatment elsewhere. Alternatively, parents may be able to shift the pattern of weight loss and/or binge purge behavior in children so that the severity of illness is decreased by the time of assessment. If successful, this intervention and clinical care pathway for waitlisted patients and their families could be disseminated to other tertiary care centers, thereby reducing mounting pressures on these centers.
- Conditions
- Eating Disorders
- Being tested
- Parental guided self-help version of FBT-pre-recorded videos and readings from the book
- Keywords
- eating disorders, waitlist intervention, pandemic, children, clinical care pathway
- Medical subject headings
- Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parental guided self-help version of FBT-pre-recorded videos and readings from the bookBehavioural
Each participant will receive a series of pre-recorded videos of parental guided self help version FBT. There will be10 videos of about 10 minutes each. The videos will include content on empowering parents to renourish their child and interrupt binge/purge behaviors. Readings will be assigned to each participant from the book "Help Your Teenager Beat and Eating Disorder". There will be psychoeducational content on the dangers and medical complications of eating disorders. The readings will also contain content on coping skills for young people including relaxation, mindfulness strategies, and distress tolerance skills.
| Study group | Role | What they receive |
|---|---|---|
| Parents who have a child/adolescent with an eating disorder on waitlist | Experimental | Each participant will receive a series of pre-recorded videos and book -(10 videos of about 10 minutes each, along with the book "Help Your Teenager Beat an Eating Disorder"). This will include content on empowering parents to renourish their child and interrupt binge/purge behaviors. Receives: Behavioral: Parental guided self-help version of FBT-pre-recorded videos and readings from the book |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight trajectory
Change in weight trajectory will be measured over the time period of 14 weeks, starting from the Baseline till the end of the study at 14 weeks
Measured: Weight will be collected weekly (in kgs) for 14 weeks. (6 weeks pre intervention, 2 weeks during intervention and 6 weeks post intervention)
Binge/purge episodes trajectory
Change in trajectory of symptoms (number of binge/purge episodes) will be measured pre and post intervention.
Measured: Number of binge/purge episodes will be collected weekly for 14 weeks. (6 weeks pre intervention, 2 weeks during intervention and 6 weeks post intervention)
Length of wait time
Average length of wait time pre and post implementation will be determined by examining wait time in the month prior to implementation for new referrals, compared to the average wait time for new referrals in the month following the completion of the study period
Measured: At 14 weeks
Change in number of parents who accepted to participate in the study
In terms of recruitment, the investigators will examine the number of parents agree to participate versus the number of families invited to the study.
Measured: Baseline and at 14 weeks
Change in number of parents who remain in the study
In terms of retention, the investigators will compare the number of parents completed the study to the number of parents enrolled.
Measured: Baseline and at 14 weeks
Secondary outcomes (5)
Change in Eating Disorder Questionnaire -parent version
Eating Disorder Examination Questionnaire -parent version (EDE-Q) will measures the severity of the characteristic psychopathology of eating disorders. The EDE-Q yields four subscale scores (Restraint, Eating Concern, Weight Concern, and Shape Concern) and a global score measuring the overall severity of eating disorder psychopathology.
Measured: Baseline and at 14 weeks
Change in Parent Versus Eating Disorder Scale
Parent Versus Eating Disorder Scale (PvEDs) is a self-efficacy tool, specifically focused on parental self-efficacy related to re-feeding their child with an Eating Disorder.
Measured: Baseline and at 14 weeks
Change in Nine Item Avoidant/Restrictive Food Intake disorder screen
Nine Item Avoidant/Restrictive Food Intake disorder screen (NIAS) -Parental version is a 9-item, Likert scale questionnaire that inquires about picky eating, interest in food, and eating habits driven by a fear of negative consequences. Minimum score is 0 and maximum is 45. A score of ≥ 24 is considered a positive ARFID screen.
Measured: Baseline and at 14 weeks
Change in Pediatric Symptom Checklist-17
Pediatric Symptom Checklist-17 (PSC-17) is a 17-item general mental health screening tool that can help to assess the likelihood of finding any mental health disorder. Minimum score is 0 and maximum is 35. A total score of 15 or more points may indicate the need for a referral to a qualified medical or mental health professional.
Measured: Baseline and at 14 weeks
Change in Carers Needs Assessment Measure
Carers Needs Assessment Measure (CaNAM): This 47 item questionnaire is designed to assess the needs of a carer of someone with an eating disorder. The minimum score is 0, the maximum score is 64. A higher score indicates that the carer has received sufficient information and support for themselves and their child.
Measured: Baseline and at 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2021
- Study start30 Jul 2021
- Primary completion4 Feb 2022
- Study completion4 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eating DisordersStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Couturier, McMaster University
- Investigators
- Jennifer Couturier, MD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04812899
- Sponsor's protocol ID
- 13223
- Acronym
- WICFAS
- Status last verified
- Mar 2022
- First submitted
- 18 Mar 2021
- Last updated
- 29 Mar 2022
- 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 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of a Waitlist Intervention and Clinical Care Pathway for Families Awaiting Services at McMaster Children's Hospital Eating Disorders Program: A Feasibility Study
- ClinicalTrials.gov ID
- NCT04812899
- Acronym / sponsor ID
- WICFAS / 13223
- Conditions
- Eating Disorders
- Keywords
- eating disorders, waitlist intervention, pandemic, children, clinical care pathway
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- 30 Jul 2021 (actual)
- Primary completion
- 4 Feb 2022 (actual)
- Study completion
- 4 Feb 2022 (actual)
- First posted
- 24 Mar 2021 (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 COVID-19 pandemic has resulted in several challenges in service delivery for the eating disorders program at McMaster Children's Hospital. Long waiting lists prior to the pandemic (6-9 month wait time) have been made worse by an interruption in service during the initial stages of the pandemic. New routine assessments were placed on hold for many months, while only the most urgently ill children were seen. This, in combination with a dramatic increase in new referrals has resulted in a long waitlist. Now families are waiting 12-18 months for service. The resulting waitlist is now unmanageable and unsafe. Investigators wish to study the implementation of a waitlist intervention which will educate parents on how to start to renourish their children and interrupt eating disordered behaviors. The intervention will consist of a series of educational videos and a book on how to help their children. It is hoped that this intervention can lessen the need for hospitalization and can change the trajectory of symptoms while waiting for service. A clinical care pathway will also be developed to ensure those waiting receive the most appropriate treatment.
Detailed description
Investigators would like to study the implementation of an adapted FBT model in which there is no therapist involvement and the intervention is delivered to families on the waitlist of Eating Disorder program at McMaster Children's Hospital. The intervention would involve a series of prerecorded videos and reading material. This, in combination with the development of a clinical care pathway, would help to manage the extraordinary volumes of referrals recently been received. The need to social distance brought on by the pandemic presents the opportunity to consider the value of this waitlist intervention as a structured program for parents who have a child waiting for service. A model such as this could dramatically improve parental abilities to begin to re-feed their children, thereby reducing acuity and time spent in treatment. Similarly, some parents on the waitlist may decide that the proposed treatment model is not suitable after they have received the proposed waitlist intervention, and may wish to seek treatment elsewhere. Alternatively, parents may be able to shift the pattern of weight loss and/or binge purge behavior in children so that the severity of illness is decreased by the time of assessment. If successful, this intervention and clinical care pathway for waitlisted patients and their families could be disseminated to other tertiary care centers, thereby reducing mounting pressures on these centers.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parents who have a child/adolescent with an eating disorder on waitlist | Experimental | Behavioral: Parental guided self-help version of FBT-pre-recorded videos and readings from the bookEach participant will receive a series of pre-recorded videos and book -(10 videos of about 10 minutes each, along with the book "Help Your Teenager Beat an Eating Disorder"). This will include content on empowering parents to renourish their child and interrupt binge/purge behaviors. |
Who may qualify
- Ages
- 7 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Parents of a child or adolescent (6-17 years) with an Eating Disorder.
- Have an access to the internet/computer.
- Have an access to a weigh scale in their home environment
- Have the capacity to write, speak and understand English
Key exclusion criteria (3 listed)
- don't have the capacity to write, speak and understand English
- don't have access to the internet/computer
- don't have a child or adolescent with an eating disorder
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 |
|---|---|---|
| Parental guided self-help version of FBT-pre-recorded videos and readings from the bookEach participant will receive a series of pre-recorded videos of parental guided self help version FBT. There will be10 videos of about 10 minutes each. The videos will include content on empowering parents to renourish their child and interrupt binge/purge behaviors. Readings will be assigned to each participant from the book "Help Your Teenager Beat and Eating Disorder". There will be psychoeducational content on the dangers and medical complications of eating disorders. The readings will also contain content on coping skills for young people including relaxation, mindfulness strategies, and distress tolerance skills. | Behavioural | Parents who have a child/adolescent with an eating disorder on waitlist |
Primary outcome
Weight trajectory
Time frame: Weight will be collected weekly (in kgs) for 14 weeks. (6 weeks pre intervention, 2 weeks during intervention and 6 weeks post intervention)
Change in weight trajectory will be measured over the time period of 14 weeks, starting from the Baseline till the end of the study at 14 weeks
Binge/purge episodes trajectory
Time frame: Number of binge/purge episodes will be collected weekly for 14 weeks. (6 weeks pre intervention, 2 weeks during intervention and 6 weeks post intervention)
Change in trajectory of symptoms (number of binge/purge episodes) will be measured pre and post intervention.
Length of wait time
Time frame: At 14 weeks
Average length of wait time pre and post implementation will be determined by examining wait time in the month prior to implementation for new referrals, compared to the average wait time for new referrals in the month following the completion of the study period
Change in number of parents who accepted to participate in the study
Time frame: Baseline and at 14 weeks
In terms of recruitment, the investigators will examine the number of parents agree to participate versus the number of families invited to the study.
Change in number of parents who remain in the study
Time frame: Baseline and at 14 weeks
In terms of retention, the investigators will compare the number of parents completed the study to the number of parents enrolled.
5 secondary outcomes
Change in Eating Disorder Questionnaire -parent version
Time frame: Baseline and at 14 weeks
Change in Parent Versus Eating Disorder Scale
Time frame: Baseline and at 14 weeks
Change in Nine Item Avoidant/Restrictive Food Intake disorder screen
Time frame: Baseline and at 14 weeks
Change in Pediatric Symptom Checklist-17
Time frame: Baseline and at 14 weeks
Change in Carers Needs Assessment Measure
Time frame: Baseline and at 14 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 29 Mar 2022.
- 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.
Jennifer Couturier, MD principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parental guided self-help version of FBT-pre-recorded videos and readings from the book in people with Eating Disorders, run by McMaster University 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 4 inclusion and 3 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 29 Mar 2022. 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?
Weight trajectory (time frame: Weight will be collected weekly (in kgs) for 14 weeks. (6 weeks pre intervention, 2 weeks during intervention and 6 weeks post intervention)). The study lists 5 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 29 Mar 2022.