Adapting and Adopting Highly Specialized Pediatric Eating Disorder Treatment to Virtual Care: Implementation Research for the COVID-19 Context and Beyond (vFBT)

September 6, 2022 updated by: Jennifer Couturier
The COVID-19 pandemic has had detrimental effects on mental health. Individuals with eating disorders (EDs) are no exception, exhibiting increased symptoms and exacerbated feelings of isolation and anxiety. Across Canada, in-person outpatient services have been quickly replaced with virtual care, yet practitioners and patients have noted substantial challenges in adapting ED-related care virtually. Given the success of our previous research on Family-Based Treatment (FBT) for EDs, as well as the rapid transition to virtual care during COVID-19, there is an urgent need to adapt FBT to virtual formats and adopt it in the ED network. Using a multi-site case study with a mixed method pre/post design, this study aims to examine the implementation of virtual FBT (vFBT) as well as its impact within six ED programs in Ontario, building on the investigator's previous work, and further developing capacity in the system. The investigator will develop implementation teams at each site and provide a virtual training workshop on vFBT, with ongoing consultation during initial implementation. The investigator proposes to examine implementation success by studying fidelity to vFBT, as well as team and patient/family experience with virtual care, and patient outcomes. These findings for virtual care will not only be important in the COVID-19 context but are also vital in the North, where access to specialized services is extremely limited.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Newmarket, Ontario, Canada, L3Y 2P9
        • Southlake Regional Health Centre
      • Thunder Bay, Ontario, Canada, P7B 5G7
        • St. Joseph's Care Group
      • Toronto, Ontario, Canada, M2J 0B1
        • North York General Hospital
      • Waterloo, Ontario, Canada, N2J 4M1
        • CMHA Waterloo Wellington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

10 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Youth must be under 18 years of age in order to participate
  • Youth must have a diagnosis of Anorexia Nervosa in order to participate
  • Must have the capacity to write, speak, and understand English
  • Must have access to a computer and the internet.

Exclusion Criteria:

  • Individuals 18 years of age and older are unable to participate
  • Youth without a diagnosis of Anorexia Nervosa are unable to participate
  • Individuals who cannot write, speak and understand English are unable to participate
  • Individuals who do not have access to a computer and the internet are unable to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Virtual Family-Based Treatment
Family-based treatment is the gold standard treatment for youth and adolescents with anorexia nervosa. A therapist works with the family to help parents take charge of the process of re-feeding their child, and with progress this control is gradually given back to the youth/adolescent. Other developmental issues are discussed in order to help the youth/adolescent get back to normal development.
Behavioral: Virtual Family-Based Treatment
Treatment involving the youth/adolescent who has been diagnosed with anorexia nervosa and their family, delivered virtually via videoconferencing.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Key components of FBT
Time Frame: Completed after session 4 of treatment, approximately 4 months
Measured by a self-report questionnaire entitled Key Measure of Therapist Behaviours and Self-Efficacy in FBT (an indicator of therapist adherence to the key components of standard FBT within the vFBT model)
Completed after session 4 of treatment, approximately 4 months
Fidelity
Time Frame: Completed after the session 4 of treatment, approximately 4 months
Fidelity to vFBT, measured by FBT fidelity ratings of the first four sessions of vFBT using the FBT Fidelity and Adherence Check (experts in FBT fidelity rating will rate the recordings).
Completed after the session 4 of treatment, approximately 4 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Qualitative experience of participants
Time Frame: Completed after session 4 of treatment, approximately 4 months
Experiences of the therapists, medical practitioners, administrators, and families in vFBT, qualitatively measured during semi-structured focus groups
Completed after session 4 of treatment, approximately 4 months
Change in Weight
Time Frame: At baseline before treatment, and at 1 week, 2 weeks, 3 weeks, and 4 weeks.
Weight will be measured in kilograms.
At baseline before treatment, and at 1 week, 2 weeks, 3 weeks, and 4 weeks.
Change in Number of Binge/Purge Episodes
Time Frame: At baseline before treatment, and at 1 week, 2 weeks, 3 weeks, and 4 weeks.
The number of binge/purge episodes each week will be recorded by patients/their families.
At baseline before treatment, and at 1 week, 2 weeks, 3 weeks, and 4 weeks.
Therapists' Change in Readiness
Time Frame: At baseline, after training (approx. 1 month), and after 4 sessions of treatment (approx. 4 months)
The Brief Individual Readiness to Change Scale will indicate how ready therapists feel they are to change. Higher scores indicate greater readiness to use research-based direct service techniques. Minimum score is 0, maximum score is 20.
At baseline, after training (approx. 1 month), and after 4 sessions of treatment (approx. 4 months)
Therapists' Change in Attitudes about Evidence Based Practice
Time Frame: At baseline, after training (approx. 1 month), and after 4 sessions of treatment (approx. 4 months)
Their attitudes about evidence-based practice will be assessed using the Evidence Based Practice Attitudes Scale (EBPAS). The subscales include requirements, appeal, openness and divergence. The score for each subscale is created by computing a mean score for the items that load on a given subscale. Minimum score for each subscale is 0, maximum score for each subscale is 4.
At baseline, after training (approx. 1 month), and after 4 sessions of treatment (approx. 4 months)
Therapists' Change in Confidence related to the Intervention
Time Frame: At baseline, after training (approx. 1 month), and after 4 sessions of treatment (approx. 4 months)
Their confidence related to the intervention will be assessed by administering an adapted version of the Perceived Attributes of the Principles of Effectiveness Scale (MPAS). Higher scores are indicative of more favorable perception for FBT content. The minimum score is 18, the maximum score is 90.
At baseline, after training (approx. 1 month), and after 4 sessions of treatment (approx. 4 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jennifer Couturier

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jennifer Couturier, MD MSc, McMaster University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 9, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 17, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 18, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 22, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 10, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 6, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 12722

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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