跳至主要内容
临床试验/NCT07518641
NCT07518641尚未招募不适用

Feasibility of the TransitionED Framework for Youth and Young Adults With Eating Disorders

McMaster University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
试验地点
2
主要终点
Acceptability

研究概览

简要总结

Moving from pediatric (children's) health care to adult health care can be challenging for youth and young adults with eating disorders. Many young people and families report feeling unprepared, unsure of what to expect, and worried about losing support during this time. Gaps in care during this transition can increase stress and make recovery more difficult.

This study is testing a structured transition support program called the TransitionED framework. The goal is to see whether this program can be successfully used in real hospital settings and whether youth, caregivers, and clinicians find it helpful.

The TransitionED framework is designed to help youth and families prepare for the move to adult care. It includes:

  1. A transition planning package for youth
  2. A separate planning package for caregivers
  3. At least two guided transition meetings with a clinician
  4. A short "Personal Transition Profile" written by the youth to help new adult providers understand them better
  5. Optional virtual peer support sessions for youth and for caregivers
  6. Tools to help pediatric and adult providers communicate more clearly

Youth who are 16 years or older and currently receiving care in a participating pediatric eating disorder program may be invited to join, along with one caregiver. Clinicians and program leaders will also take part to help deliver and evaluate the program.

Participants will complete surveys at the beginning of the study, about two months later, and six months after finishing the program. Some participants will also take part in interviews to share their experiences.

This study is focused on feasibility. That means the main goal is to learn whether this transition program is practical, acceptable, and workable in everyday clinical care. What we learn will help improve transition support for youth and young adults with eating disorders in the future.

详细描述

Youth and young adults (YYA) with eating disorders (EDs) face well-documented challenges when transitioning from pediatric to adult-oriented health care systems. Poorly planned transitions are associated with disruptions in continuity of care, reduced engagement with services, and increased clinical risk. In ED populations, these risks may be heightened due to illness severity, developmental vulnerability, differences between pediatric and adult care models, and the high level of caregiver involvement in pediatric treatment.

Despite national and international recommendations supporting structured transition planning, many programs lack consistent, system-level approaches to guide the transition process. As a result, youth and families often report feeling unprepared, excluded from decision-making, and uncertain about what to expect when moving to adult services.

The TransitionED program of research was developed to address these gaps. In Phase 1, Canadian clinical practice guidelines for transitions in eating disorder care were developed. In Phase 2, youth with lived experience, caregivers, clinicians, and system partners participated in a national co-design process to translate these guidelines into a structured healthcare transition framework suitable for real-world implementation.

The current study represents Phase 3 of the TransitionED program and focuses on evaluating the feasibility of implementing the TransitionED framework in two Canadian pediatric eating disorder programs. This is an implementation-focused feasibility study rather than a clinical efficacy trial.

The primary objective is to assess feasibility across multiple domains, guided by Bowen et al.'s feasibility framework. These domains include:

研究设计

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

盲法说明

No parties are masked in this study. This is an open-label feasibility study. Participants, care providers, investigators, and outcome assessors are aware of framework delivery.

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Youth and Young Adults (YYA):
  • Currently receiving paediatric eating disorder care at a participating study site.
  • Age 16 years or or older (approaching age-based transition to adult-care)
  • Expressed interest in transitioning to adult eating disorder care or other appropriate adult mental health services
  • Identified by the clinical team as appropriate to begin formal transition planning (e.g., sufficient transition readiness and interest in ongoing care)
  • Able and willing to provide informed consent/assent (as applicable at the site) and participate in study procedures
  • Caregivers:
  • One caregiver (e.g., parent/legal guardian) of a participating YYA
  • Able and willing to provide informed consent and participate in study procedures (including questionnaires and interviews)
  • Clinicians (intervention deliverers):
  • Patient facing clinician at a participating site who provides transition support for participating YYA/caregivers and is responsible for delivering intervention components (e.g., joint meeting(s), communication/coordination related to the transition).
  • Able and willing to provide informed consent and participate in study procedures (e.g., focus groups)
  • Implementation Team Members:
  • Program leadership/managers/senior clinicians at a participating site involved in implementation of the intervention at that site.
  • Able and willing to provide informed consent and participate in study procedures (e.g., focus group).

排除标准

  • Not receiving pediatric eating disorder care at a participating site.
  • Under age 16 years
  • Does not express interest in transitioning to adult eating disorder care or other appropriate adult mental health services.
  • Not identified by the clinical team as ready/appropriate to engage in formal transition planning during the study period (e.g., insufficient transition readiness or not currently at the transition-planning stage).
  • Unable to provide informed consent/assent or unable to participate in study procedures (e.g., due to significant cognitive/communication barriers as determined by the clinical/research team).
  • Caregivers:
  • Not the caregiver of an enrolled YYA (only one caregiver per YYA is enrolled).
  • Unable to provide informed consent or participate in study procedures.
  • Clinicians and Implementation Team Members:
  • Not affiliated with a participating site or not in an eligible role as defined above.
  • Peripheral providers who may be involved in care but are not enrolled as participants (e.g., family physicians or adult providers who might attend a joint meeting).
  • Unable to provide informed consent or participate in study procedures.

研究组 & 干预措施

TransitionED Framework

Experimental

Participants receive the TransitionED framework, a structured, guideline-informed healthcare transition approach for youth and young adults with eating disorders. The framework includes youth and caregiver transition planning packages, at least two clinician-led transition meetings (including coordination with adult providers), a youth-authored Personal Transition Profile to support information transfer, optional peer support sessions for youth and caregivers, and a communication guide to promote collaboration between paediatric and adult services. Framework delivery occurs approximately two months within routine clinical care.

干预措施: TransitionED Healthcare Transition Framework (Behavioral)

结局指标

主要结局

Acceptability

时间窗: Post-intervention (approximately 8 weeks after enrollment) and at 6-month follow-up.

Acceptability refers to the extent to which youth and young adults (YYA), caregivers, clinicians, and implementation team members perceive the TransitionED Healthcare Transition Framework as appropriate, satisfactory, and useful. Acceptability will be assessed using qualitative interviews and focus groups conducted with participants following implementation of the framework. Interviews will explore participants' experiences with the framework, perceived usefulness, ease of use, perceived burden, and overall satisfaction with the transition support process.

Implementation Fidelity of the TransitionED Healthcare Transition Framework

时间窗: From enrollment through framework completion (approximately 8 weeks post-enrollment) and throughout the implementation period at each site.

Implementation fidelity refers to the extent to which the TransitionED framework is delivered as intended. Fidelity will be measured as the proportion of core intervention components delivered as planned, including completion of the Transition Planning Package, completion of the Personal Transition Profile, and delivery of clinician-facilitated transition meetings. Fidelity data will be collected using structured implementation tracking logs completed by clinicians and research staff.

Practicality and Integration of the TransitionED Healthcare Transition Framework

时间窗: From enrollment through framework completion (approximately 8 weeks post-enrollment) and during the active implementation period at each site.

Practicality and integration refer to the extent to which the TransitionED framework can be implemented within routine clinical workflows using existing clinical resources. This outcome will be assessed through clinician surveys and qualitative interviews examining feasibility of delivering the framework, perceived fit within existing clinical workflows, time required to deliver framework components, and barriers or facilitators to implementation.

次要结局

  • Transition Readiness (TRAQ)(Baseline (at enrollment), approximately 8 weeks post-enrollment, and 6 months post-enrollment.)
  • Eating Disorder Symptoms(Baseline (at enrollment), approximately 8 weeks post-enrollment, and 6 months post-enrollment.)
  • Anxiety(Baseline (at enrollment), approximately 8 weeks post-enrollment, and 6 months post-enrollment.)
  • Depression(Baseline (at enrollment), approximately 8 weeks post-enrollment, and 6 months post-enrollment.)
  • Transition Outcomes(Assessed at 6 months post-enrollment and following transfer to adult-oriented care (where applicable).)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jennifer Couturier

Professor

McMaster University

研究点 (2)

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