Clinical trial NCT04678843: Adapting and Adopting Highly Specialized Pediatric Eating Disorder Treatment to Virtual Care: Implementation Research for the COVID-19 Context and Beyond
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
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Anorexia Nervosa
Keywords: anorexia nervosa
youth
adolescents
eating disorders
family-based treatment
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2020-12-22
Enrollment: 36
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: We study a blended implementation approach for Family-Based Treatment delivered via videoconferencing (FBT-V)
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Key components of FBT
timeFrame: Completed after session 4 of treatment, approximately 4 months
measure: Fidelity
timeFrame: Completed after the session 4 of treatment, approximately 4 months
Secondary outcomes:
measure: Qualitative experience of participants
timeFrame: Completed after session 4 of treatment, approximately 4 months
measure: Change in Weight
timeFrame: At baseline before treatment, and at 1 week, 2 weeks, 3 weeks, and 4 weeks.
measure: Change in Number of Binge/Purge Episodes
timeFrame: At baseline before treatment, and at 1 week, 2 weeks, 3 weeks, and 4 weeks.
measure: Therapists' Change in Readiness
timeFrame: At baseline, after training (approx. 1 month), and after 4 sessions of treatment (approx. 4 months)
measure: Therapists' Change in Attitudes about Evidence Based Practice
timeFrame: At baseline, after training (approx. 1 month), and after 4 sessions of treatment (approx. 4 months)
measure: Therapists' Change in Confidence related to the Intervention
timeFrame: At baseline, after training (approx. 1 month), and after 4 sessions of treatment (approx. 4 months)
Other outcomes:
Locations:
city: Newmarket
country: Canada
facility: Southlake Regional Health Centre
state: Ontario
city: Thunder Bay
country: Canada
facility: St. Joseph's Care Group
state: Ontario
city: Toronto
country: Canada
facility: North York General Hospital
state: Ontario
city: Waterloo
country: Canada
facility: CMHA Waterloo Wellington
state: Ontario
Study officials:
affiliation: McMaster University
name: Jennifer Couturier, MD MSc
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.