- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07518641
Feasibility of the TransitionED Framework for Youth and Young Adults With Eating Disorders (TransitionED 3)
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:
- A transition planning package for youth
- A separate planning package for caregivers
- At least two guided transition meetings with a clinician
- A short "Personal Transition Profile" written by the youth to help new adult providers understand them better
- Optional virtual peer support sessions for youth and for caregivers
- 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.
Study Overview
Status
Intervention / Treatment
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:
- Acceptability: Whether the framework is perceived as appropriate and helpful by youth, caregivers, clinicians, and program leadership.
- Implementation and Fidelity: Whether the framework can be delivered as intended within routine clinical care.
- Practicality: Whether the framework can be carried out using existing resources and workflows.
- Integration: Whether the framework fits within existing clinical systems and can be sustained over time.
- 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:
- Transition Planning Packages for youth and caregivers to guide reflection, preparation, and role clarification.
- Structured Transition Meetings led by a clinician to support collaborative planning and coordination with adult providers.
- A Personal Transition Profile authored by the youth to facilitate information sharing and reduce repetition during transfer of care.
- Peer Support Sessions (youth-to-youth and caregiver-to-caregiver) to provide lived-experience-based guidance and reassurance.
- 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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jennifer Couturier, MD, MSc
- Phone Number: 76035 905-521-2100
- Email: coutur@mcmaster.ca
Study Locations
-
-
Alberta
-
Calgary, Alberta, Canada, T2N 1N4
- University of Calgary
-
Contact:
- Gina Dimitropoulos, MSW, PhD, RSW
- Phone Number: (403) 220-5110
- Email: gdimit@ucalgary.ca
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-
Ontario
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Hamilton, Ontario, Canada, L8N3Z5
- McMaster University
-
Contact:
- Jennifer Couturier, MD, MSc
- Phone Number: 76035 905-521-2100
- Email: coutur@mcmaster.ca
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: TransitionED Framework
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.
|
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 program-level communication and collaboration guide.
The framework is embedded within routine clinical care and focuses on system-level coordination, readiness building, and continuity across pediatric and adult services.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Acceptability
Time Frame: 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.
|
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.
|
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.
|
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.
|
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.
|
From enrollment through framework completion (approximately 8 weeks post-enrollment) and during the active implementation period at each site.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Transition Readiness (TRAQ)
Time Frame: Baseline (at enrollment), approximately 8 weeks post-enrollment, and 6 months post-enrollment.
|
Transition readiness will be measured using the Transition Readiness Assessment Questionnaire (TRAQ), a validated self-report instrument assessing youths' skills and confidence in managing their health care and navigating adult-oriented services. TRAQ items are scored on a 5-point Likert scale ranging from 1 to 5, with higher scores indicating greater transition readiness. The instrument generates both domain scores and a total score. Change in TRAQ scores over time will be examined. |
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.
|
Eating disorder symptom severity will be measured using the Eating Disorder Examination Questionnaire (EDE-Q 6.0), a validated self-report instrument widely used in eating disorder research and clinical care. The EDE-Q generates a global score and four subscale scores (restraint, eating concern, weight concern, and shape concern). Items are rated on a 7-point scale ranging from 0 to 6, with higher scores indicating greater eating disorder symptom severity. Change in EDE-Q scores over time will be examined. |
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.
|
Anxiety symptom severity will be measured using the Generalized Anxiety Disorder 7-item scale (GAD-7). The GAD-7 produces a total score ranging from 0 to 21, with higher scores indicating greater anxiety symptom severity. Change in GAD-7 scores over time will be examined. |
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.
|
Depressive symptom severity will be measured using the Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 produces a total score ranging from 0 to 27, with higher scores indicating greater depressive symptom burden. Change in PHQ-9 scores over time will be examined. |
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).
|
Early transition outcomes will be assessed using participant report and clinical documentation to examine continuity of care following transfer from pediatric to adult services.
Outcomes may include attendance at the first scheduled adult care appointment, time from pediatric discharge to adult intake, engagement in adult services within 3 months of transfer, and participant-reported satisfaction with the transition process.
|
Assessed at 6 months post-enrollment and following transfer to adult-oriented care (where applicable).
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jennifer Couturier, MD, MSc, McMaster University
- Principal Investigator: Georgina Dimitropoulos, MSW, PhD, RSW, University of Calgary
Publications and helpful links
General Publications
- Bowen DJ, Kreuter M, Spring B, Cofta-Woerpel L, Linnan L, Weiner D, Bakken S, Kaplan CP, Squiers L, Fabrizio C, Fernandez M. How we design feasibility studies. Am J Prev Med. 2009 May;36(5):452-7. doi: 10.1016/j.amepre.2009.02.002.
- Hsieh HF, Shannon SE. Three approaches to qualitative content analysis. Qual Health Res. 2005 Nov;15(9):1277-88. doi: 10.1177/1049732305276687.
- Creswell JW, Clark VLP. Designing and conducting mixed methods research. Sage publications; 2017.
- 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 services research. 2013;48(6pt2):2134-2156.
- Bradshaw C, Atkinson S, Doody O. Employing a qualitative description approach in health care research. Global qualitative nursing research. 2017;4:2333393617742282.
- Sandelowski M. What's in a name? Qualitative description revisited. Research in nursing & health. 2010;33(1):77-84.
- Sandelowski M. Whatever happened to qualitative description? Research in nursing & health. 2000;23(4):334-340.
- Dimitropoulos G, Nicula M, Krishnapillai A, et al. Transitions for youth and young adults with eating disorders and/or other mental health conditions: a Canadian guideline. Journal of Eating Disorders. 2025;13(1):158.
- Dimitropoulos G, Singh M, Mushquash C, et al. TransitionED: A protocol for Co-designing and implementing Canadian practice guidelines for transitions for youth with eating disorders. European Eating Disorders Review. 2025;33(6):1175-1189.
- Nadarajah A, Dimitropoulos G, Grant C, Webb C, Couturier J. Impending transition from pediatric to adult health services: a qualitative study of the experiences of adolescents with eating disorders and their caregivers. Frontiers in psychiatry. 2021;12:624942.
- Dimitropoulos G, Toulany A, Herschman J, et al. A qualitative study on the experiences of young adults with eating disorders transferring from pediatric to adult care. Eating disorders. 2015;23(2):144-162.
- Dimitropoulos G, Tran AF, Agarwal P, Sheffield B, Woodside B. Navigating the transition from pediatric to adult eating disorder programs: perspectives of service providers. International Journal of Eating Disorders. 2012;45(6):759-767.
- Treasure J, Schmidt U, Hugo P. Mind the gap: service transition and interface problems for patients with eating disorders. The British Journal of Psychiatry. 2005;187(5):398-400.
- Singh SP, Paul M, Ford T, et al. Process, outcome and experience of transition from child to adult mental healthcare: multiperspective study. The British Journal of Psychiatry. 2010;197(4):305-312.
- Cleverley K, Rowland E, Bennett K, Jeffs L, Gore D. Identifying core components and indicators of successful transitions from child to adult mental health services: a scoping review. European Child & Adolescent Psychiatry. 2020;29(2):107-121.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- Mental Health Services
- Mixed Methods
- Young adults
- Feasibility study
- Knowledge translation
- eating disorders
- Implementation science
- Continuity of care
- Peer support
- Transition readiness
- Transition to Adult Care
- Adolescent health
- Eating disorder treatment
- healthcare transitions
- Paediatric to adult care
- Clinical Practice guidelines
- TRAQ
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19859
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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