跳至主要内容
临床试验/NCT04678843
NCT04678843已完成早期 1 期

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

Jennifer Couturier8 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2021年2月9日最近更新:
适应症

试验速览

阶段
早期 1 期
状态
已完成
发起方
入组人数
36
试验地点
8
主要终点
Fidelity

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
10 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

结局指标

主要结局

Fidelity

时间窗: 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).

Key components of FBT

时间窗: 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)

次要结局

  • Qualitative experience of participants(Completed after session 4 of treatment, approximately 4 months)
  • Therapists' Change in Confidence related to the Intervention(At baseline, after training (approx. 1 month), and after 4 sessions of treatment (approx. 4 months))
  • Change in Weight(At baseline before treatment, and at 1 week, 2 weeks, 3 weeks, and 4 weeks.)
  • Therapists' Change in Attitudes about Evidence Based Practice(At baseline, after training (approx. 1 month), and after 4 sessions of treatment (approx. 4 months))
  • Therapists' Change in Readiness(At baseline, after training (approx. 1 month), and after 4 sessions of treatment (approx. 4 months))
  • Change in Number of Binge/Purge Episodes(At baseline before treatment, and at 1 week, 2 weeks, 3 weeks, and 4 weeks.)

研究者

发起方
Jennifer Couturier
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Jennifer Couturier

Principal Investigator

McMaster University

研究点 (8)

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