Adapting and Adopting Highly Specialized Pediatric Eating Disorder Treatment to Virtual Care: Implementation Research for the COVID-19 Context and Beyond (vFBT)
Primary Purpose
Anorexia Nervosa
Status
Completed
Phase
Early Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Virtual Family-Based Treatment
Sponsored by
About this trial
This is an interventional treatment trial for Anorexia Nervosa focused on measuring anorexia nervosa, youth, adolescents, eating disorders, family-based treatment
Eligibility Criteria
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
Sites / Locations
- Southlake Regional Health Centre
- St. Joseph's Care Group
- North York General Hospital
- CMHA Waterloo Wellington
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Virtual Family-Based Treatment
Arm Description
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.
Outcomes
Primary Outcome Measures
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)
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).
Secondary Outcome Measures
Qualitative experience of participants
Experiences of the therapists, medical practitioners, administrators, and families in vFBT, qualitatively measured during semi-structured focus groups
Change in Weight
Weight will be measured in kilograms.
Change in Number of Binge/Purge Episodes
The number of binge/purge episodes each week will be recorded by patients/their families.
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.
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.
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.
Full Information
NCT ID
NCT04678843
First Posted
December 17, 2020
Last Updated
September 6, 2022
Sponsor
Jennifer Couturier
1. Study Identification
Unique Protocol Identification Number
NCT04678843
Brief Title
Adapting and Adopting Highly Specialized Pediatric Eating Disorder Treatment to Virtual Care: Implementation Research for the COVID-19 Context and Beyond
Acronym
vFBT
Official Title
Adapting and Adopting Highly Specialized Pediatric Eating Disorder Treatment to Virtual Care: Implementation Research for the COVID-19 Context and Beyond
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
February 9, 2021 (Actual)
Primary Completion Date
July 31, 2021 (Actual)
Study Completion Date
August 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jennifer Couturier
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anorexia Nervosa
Keywords
anorexia nervosa, youth, adolescents, eating disorders, family-based treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Model Description
We study a blended implementation approach for Family-Based Treatment delivered via videoconferencing (FBT-V)
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Virtual Family-Based Treatment
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Virtual Family-Based Treatment
Intervention Description
Treatment involving the youth/adolescent who has been diagnosed with anorexia nervosa and their family, delivered virtually via videoconferencing.
Primary Outcome Measure Information:
Title
Key components of FBT
Description
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)
Time Frame
Completed after session 4 of treatment, approximately 4 months
Title
Fidelity
Description
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).
Time Frame
Completed after the session 4 of treatment, approximately 4 months
Secondary Outcome Measure Information:
Title
Qualitative experience of participants
Description
Experiences of the therapists, medical practitioners, administrators, and families in vFBT, qualitatively measured during semi-structured focus groups
Time Frame
Completed after session 4 of treatment, approximately 4 months
Title
Change in Weight
Description
Weight will be measured in kilograms.
Time Frame
At baseline before treatment, and at 1 week, 2 weeks, 3 weeks, and 4 weeks.
Title
Change in Number of Binge/Purge Episodes
Description
The number of binge/purge episodes each week will be recorded by patients/their families.
Time Frame
At baseline before treatment, and at 1 week, 2 weeks, 3 weeks, and 4 weeks.
Title
Therapists' Change in Readiness
Description
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.
Time Frame
At baseline, after training (approx. 1 month), and after 4 sessions of treatment (approx. 4 months)
Title
Therapists' Change in Attitudes about Evidence Based Practice
Description
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.
Time Frame
At baseline, after training (approx. 1 month), and after 4 sessions of treatment (approx. 4 months)
Title
Therapists' Change in Confidence related to the Intervention
Description
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.
Time Frame
At baseline, after training (approx. 1 month), and after 4 sessions of treatment (approx. 4 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Couturier, MD MSc
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Southlake Regional Health Centre
City
Newmarket
State/Province
Ontario
ZIP/Postal Code
L3Y 2P9
Country
Canada
Facility Name
St. Joseph's Care Group
City
Thunder Bay
State/Province
Ontario
ZIP/Postal Code
P7B 5G7
Country
Canada
Facility Name
North York General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M2J 0B1
Country
Canada
Facility Name
CMHA Waterloo Wellington
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2J 4M1
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35883167
Citation
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.
Results Reference
derived
PubMed Identifier
33832543
Citation
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.
Results Reference
derived
Learn more about this trial
Adapting and Adopting Highly Specialized Pediatric Eating Disorder Treatment to Virtual Care: Implementation Research for the COVID-19 Context and Beyond
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