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Completed

NCT Number: NCT04678843

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

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.

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Key information

Conditions

Anorexia Nervosa Feeding and Eating Disorders Mental Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Southlake Regional Health Centre, Newmarket, Ontario, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Virtual Family-Based Treatment

Behavioral

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

Primary outcomes

  1. Key components of FBT

    Time frame: Completed after session 4 of treatment, approximately 4 months

    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)

  2. Fidelity

    Time frame: Completed after the session 4 of treatment, approximately 4 months

    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 outcomes

  1. Qualitative experience of participants

    Time frame: Completed after session 4 of treatment, approximately 4 months

    Experiences of the therapists, medical practitioners, administrators, and families in vFBT, qualitatively measured during semi-structured focus groups

  2. Change in Weight

    Time frame: At baseline before treatment, and at 1 week, 2 weeks, 3 weeks, and 4 weeks.

    Weight will be measured in kilograms.

  3. Change in Number of Binge/Purge Episodes

    Time frame: At 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.

  4. Therapists' Change in Readiness

    Time frame: At 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.

  5. Therapists' Change in Attitudes about Evidence Based Practice

    Time frame: At 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.

  6. Therapists' Change in Confidence related to the Intervention

    Time frame: At 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.

Sponsors and collaborators

Lead sponsor

Jennifer Couturier

Other

Registry information

Acronym: vFBT

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Dec 22, 2020
Registry last updated
Sep 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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