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

Anorexia Nervosa Clinical Trial

— vFBT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04678843
• Other study ID #: 12722
• Status: Completed
• Phase: Early Phase 1
• Start date: February 9, 2021
• Est. completion date: August 1, 2021

Study information

• Verified date: September 2022
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: August 1, 2021
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa
• Feeding and Eating Disorders

Intervention

Behavioral:
• Virtual Family-Based Treatment
Treatment involving the youth/adolescent who has been diagnosed with anorexia nervosa and their family, delivered virtually via videoconferencing.

Locations

Country	Name	City	State
Canada	Southlake Regional Health Centre	Newmarket	Ontario
Canada	St. Joseph's Care Group	Thunder Bay	Ontario
Canada	North York General Hospital	Toronto	Ontario
Canada	CMHA Waterloo Wellington	Waterloo	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Jennifer Couturier

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	Change in Weight	Weight will be measured in kilograms.	At baseline before treatment, and at 1 week, 2 weeks, 3 weeks, and 4 weeks.
Secondary	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.
Secondary	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)
Secondary	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)
Secondary	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)