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Not yet recruiting NCT07518641

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

No phase Interventional Eating Disorders in Adolescence Transition of Care

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: TransitionED Healthcare Transition Framework.
Who it may be relevant to
Registry conditions: Eating Disorders in Adolescence, Transition of Care. Basic parameters: from 16 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Detailed description

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:

1. Acceptability: Whether the framework is perceived as appropriate and helpful by youth, caregivers, clinicians, and program leadership. 2. Implementation and Fidelity: Whether the framework can be delivered as intended within routine clinical care. 3. Practicality: Whether the framework can be carried out using existing resources and workflows. 4. Integration: Whether the framework fits within existing clinical systems and can be sustained over time. 5. Preliminary Efficacy: Whether participation is associated with changes in transition readiness, eating disorder symptoms, anxiety, depression, and early transition outcomes.

The TransitionED framework is a multi-component, guideline-informed approach designed to support continuity of care. Core components include:

1. Transition Planning Packages for youth and caregivers to guide reflection, preparation, and role clarification. 2. Structured Transition Meetings led by a clinician to support collaborative planning and coordination with adult providers. 3. A Personal Transition Profile authored by the youth to facilitate information sharing and reduce repetition during transfer of care. 4. Peer Support Sessions (youth-to-youth and caregiver-to-caregiver) to provide lived-experience-based guidance and reassurance. 5. A Communication and Collaboration Guide to support coordination between pediatric and adult services at the program level.

The framework is intentionally flexible to allow for site-specific adaptation while maintaining core components. Any adaptations made during implementation will be documented as part of the feasibility evaluation.

The study uses a convergent mixed methods design. Quantitative data will be collected at baseline, approximately eight weeks after enrollment, and six months later to assess transition readiness and clinical outcomes. Qualitative interviews and focus groups will explore participant experiences, perceived impact, and implementation processes. Findings from both data strands will be integrated to provide a comprehensive assessment of feasibility.

The results of this study will inform refinement of the TransitionED framework and provide essential data to support future larger-scale implementation and effectiveness studies. Ultimately, this work aims to improve continuity of care and transition experiences for youth and young adults with eating disorders.

Interventions

  • Behavioral TransitionED Healthcare Transition Framework
    The TransitionED Healthcare Transition Framework is a structured, guideline-informed, multi-component intervention designed to support youth and young adults with eating disorders transitioning from pediatric to adult care. Unlike standard transition practices, this framework integrates youth and caregiver transition planning packages, clinician-led structured transition meetings, a youth-authored Personal Transition Profile to support information transfer, optional peer support sessions, and a

Primary outcome measures

  • Acceptability [Time frame: Post-intervention (approximately 8 weeks after enrollment) and at 6-month follow-up.]
  • Implementation Fidelity of the TransitionED Healthcare Transition Framework [Time frame: From enrollment through framework completion (approximately 8 weeks post-enrollment) and throughout the implementation period at each site.]
  • Practicality and Integration of the TransitionED Healthcare Transition Framework [Time frame: From enrollment through framework completion (approximately 8 weeks post-enrollment) and during the active implementation period at each site.]
Secondary outcome measures (5)
  • Transition Readiness (TRAQ) [Time frame: Baseline (at enrollment), approximately 8 weeks post-enrollment, and 6 months post-enrollment.]
  • Eating Disorder Symptoms [Time frame: Baseline (at enrollment), approximately 8 weeks post-enrollment, and 6 months post-enrollment.]
  • Anxiety [Time frame: Baseline (at enrollment), approximately 8 weeks post-enrollment, and 6 months post-enrollment.]
  • Depression [Time frame: Baseline (at enrollment), approximately 8 weeks post-enrollment, and 6 months post-enrollment.]
  • Transition Outcomes [Time frame: Assessed at 6 months post-enrollment and following transfer to adult-oriented care (where applicable).]

Eligibility criteria

Inclusion criteria

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).

Exclusion criteria

YYA:

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Health services research

Study locations

Canada · 2 centers
  • University of Calgary — Calgary
  • McMaster University — Hamilton

Publications

  • Guetterman TC, Fàbregues S, Sakakibara R. Visuals in joint displays to represent integration in mixed methods research: A methodological review. Methods in Psychology. 2021;5:100080.
  • Fetters MD, Tajima C. Joint displays of integrated data collection in mixed methods research. International Journal of Qualitative Methods. 2022;21:16094069221104564.
  • Fetters MD, Curry LA, Creswell JW. Achieving integration in mixed methods designs-principles and practices. Health Serv Res. 2013 Dec;48(6 Pt 2):2134-56. doi: 10.1111/1475-6773.12117. Epub 2013 Oct 23. PMID 24279835
  • Hsieh HF, Shannon SE. Three approaches to qualitative content analysis. Qual Health Res. 2005 Nov;15(9):1277-88. doi: 10.1177/1049732305276687. PMID 16204405
  • Bradshaw C, Atkinson S, Doody O. Employing a Qualitative Description Approach in Health Care Research. Glob Qual Nurs Res. 2017 Nov 24;4:2333393617742282. doi: 10.1177/2333393617742282. eCollection 2017 Jan-Dec. PMID 29204457
  • Sandelowski M. What's in a name? Qualitative description revisited. Res Nurs Health. 2010 Feb;33(1):77-84. doi: 10.1002/nur.20362. PMID 20014004
  • Sandelowski M. Whatever happened to qualitative description? Res Nurs Health. 2000 Aug;23(4):334-40. doi: 10.1002/1098-240x(200008)23:43.0.co;2-g. PMID 10940958
  • Creswell JW, Clark VLP. Designing and conducting mixed methods research. Sage publications; 2017.

Identifiers

NCT: NCT07518641 · 19859

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗