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

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

Status
Completed
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04678843
Acronym
vFBT
Enrollment
36
Registered
2020-12-22
Start date
2021-02-09
Completion date
2021-08-01
Last updated
2022-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anorexia Nervosa

Keywords

anorexia nervosa, youth, adolescents, eating disorders, family-based 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.

Interventions

BEHAVIORALVirtual Family-Based Treatment

Treatment involving the youth/adolescent who has been diagnosed with anorexia nervosa and their family, delivered virtually via videoconferencing.

Sponsors

Jennifer Couturier
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

We study a blended implementation approach for Family-Based Treatment delivered via videoconferencing (FBT-V)

Eligibility

Sex/Gender
ALL
Age
10 Years to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Key components of FBTCompleted after session 4 of treatment, approximately 4 monthsMeasured 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)
FidelityCompleted after the session 4 of treatment, approximately 4 monthsFidelity 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

MeasureTime frameDescription
Change in Number of Binge/Purge EpisodesAt 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.
Therapists' Change in ReadinessAt 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.
Qualitative experience of participantsCompleted after session 4 of treatment, approximately 4 monthsExperiences of the therapists, medical practitioners, administrators, and families in vFBT, qualitatively measured during semi-structured focus groups
Therapists' Change in Confidence related to the InterventionAt 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.
Therapists' Change in Attitudes about Evidence Based PracticeAt 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.
Change in WeightAt baseline before treatment, and at 1 week, 2 weeks, 3 weeks, and 4 weeks.Weight will be measured in kilograms.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026