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

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: Completed
• Conditions: Anorexia Nervosa
• Intervention / Treatment: Behavioral: Virtual Family-Based Treatment

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Early Phase 1

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

Outcome Measure	Measure Description	Time Frame
Key components of FBT	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	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

Outcome Measure	Measure Description	Time Frame
Qualitative experience of participants	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	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	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	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	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	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

• Sponsor: Jennifer Couturier
• Investigators: Principal Investigator: Jennifer Couturier, MD MSc, McMaster University

Publications and helpful links

General Publications

• Couturier J, Pellegrini D, Grennan L, Nicula M, Miller C, Agar P, Webb C, Anderson K, Barwick M, Dimitropoulos G, Findlay S, Kimber M, McVey G, Paularinne R, Nelson A, DeGagne K, Bourret K, Restall S, Rosner J, Hewitt-McVicker K, Pereira J, McLeod M, Shipley C, Miller S, Boachie A, Engelberg M, Martin S, Holmes-Haronitis J, Lock J. A qualitative evaluation of team and family perceptions of family-based treatment delivered by videoconferencing (FBT-V) for adolescent Anorexia Nervosa during the COVID-19 pandemic. J Eat Disord. 2022 Jul 26;10(1):111. doi: 10.1186/s40337-022-00631-9. Erratum In: J Eat Disord. 2022 Dec 8;10(1):191.
• Couturier J, Pellegrini D, Miller C, Agar P, Webb C, Anderson K, Barwick M, Dimitropoulos G, Findlay S, Kimber M, McVey G, Lock J. Adapting and adopting highly specialized pediatric eating disorder treatment to virtual care: a protocol for an implementation study in the COVID-19 context. Implement Sci Commun. 2021 Apr 8;2(1):38. doi: 10.1186/s43058-021-00143-8.

Study record dates

Study Major Dates

• Study Start (Actual): February 9, 2021
• Primary Completion (Actual): July 31, 2021
• Study Completion (Actual): August 1, 2021

Study Registration Dates

• First Submitted: December 17, 2020
• First Submitted That Met QC Criteria: December 18, 2020
• First Posted (Actual): December 22, 2020

Study Record Updates

• Last Update Posted (Actual): September 10, 2022
• Last Update Submitted That Met QC Criteria: September 6, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: adolescents; anorexia nervosa; youth; eating disorders; family-based treatment
• Additional Relevant MeSH Terms: Mental Disorders; Signs and Symptoms, Digestive; Anorexia; Anorexia Nervosa; Feeding and Eating Disorders
• Other Study ID 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