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Eating Disorders in AdolescenceTransitionED 3NCT07518641

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

A study testing TransitionED Healthcare Transition Framework in people with Eating Disorders in Adolescence and Transition of Care, run by McMaster University at 2 sites in Canada.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 16 years and older
What is being tested?
TransitionED Healthcare Transition Framework
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
2 sitesCanada
Study dates
May 2026to 31 Mar 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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
Show all 15Show fewer
  • 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).

Who cannot join

  • 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).
Show all 13Show fewer
  • 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.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Jennifer Couturier, MD, MSc contact

905-521-2100 ext. 76035

coutur@mcmaster.ca

Canada2 sites

  • University of Calgary

    Calgary, Alberta, T2N 1N4

    Gina Dimitropoulos, MSW, PhD, RSW, (403) 220-5110, gdimit@ucalgary.ca

  • McMaster University

    Hamilton, Ontario, L8N3Z5

    Jennifer Couturier, MD, MSc, 905-521-2100 ext. 76035, coutur@mcmaster.ca

Other trials in Canada

About this study

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.

Read more

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.

Read the 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.

Being tested
TransitionED Healthcare Transition Framework
Keywords
eating disorders, healthcare transitions, Transition to Adult Care, Adolescent health, Young adults, Paediatric to adult care, Continuity of care, Mental Health Services, Implementation science, Feasibility study, Mixed Methods, Clinical Practice guidelines, Transition readiness, TRAQ, Peer support, Eating disorder treatment, Knowledge translation
Medical subject headings
Feeding and Eating Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TransitionED Healthcare Transition FrameworkBehavioural

    Also called Transition Intervention, Transition Framework, Transition Materials

    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.

Study groups in NCT07518641
Study groupRoleWhat they receive
TransitionED FrameworkExperimentalParticipants 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.
Receives: Behavioral: TransitionED Healthcare Transition Framework

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Acceptability

    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.

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

  2. Implementation Fidelity of the TransitionED Healthcare Transition Framework

    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.

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

  3. Practicality and Integration of the TransitionED Healthcare Transition Framework

    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.

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

Secondary outcomes (5)

  1. Transition Readiness (TRAQ)

    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.

    Measured: Baseline (at enrollment), approximately 8 weeks post-enrollment, and 6 months post-enrollment.

  2. Eating Disorder Symptoms

    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.

    Measured: Baseline (at enrollment), approximately 8 weeks post-enrollment, and 6 months post-enrollment.

  3. Anxiety

    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.

    Measured: Baseline (at enrollment), approximately 8 weeks post-enrollment, and 6 months post-enrollment.

  4. Depression

    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.

    Measured: Baseline (at enrollment), approximately 8 weeks post-enrollment, and 6 months post-enrollment.

  5. Transition Outcomes

    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.

    Measured: Assessed at 6 months post-enrollment and following transfer to adult-oriented care (where applicable).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Apr 2026
  2. Study startMay 2026 (estimated)
  3. Primary completionMar 2028 (estimated)
  4. Study completion31 Mar 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Model description
This is a single-arm feasibility study in which all enrolled youth and young adult (YYA) + caregiver dyads receive the TransitionED framework. There is no randomization and no comparison group. The study uses a repeated measures design, with quantitative data collected at baseline, approximately 8 weeks post-enrollment, and 6 months later. Qualitative interviews and focus groups are conducted following framework delivery to assess acceptability, implementation, practicality, and integration. The primary aim is to evaluate feasibility of implementation within routine clinical care settings.
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07518641
Sponsor's protocol ID
19859
Acronym
TransitionED 3
Status last verified
Apr 2026
First submitted
2 Mar 2026
Last updated
8 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Individual participant data (IPD) collected in this study include questionnaire responses, implementation tracking data, and qualitative interview data from youth and young adults with eating disorders, caregivers, clinicians, and implementation team members. Due to the sensitive nature of the population and the inclusion of qualitative interview data, there is a potential risk of participant re-identification even after de-identification, particularly given the small sample size and site-specific implementation context. For this reason, qualitative interview data and identifiable information will not be shared outside the research team. De-identified quantitative data derived from standardized questionnaires may be considered for sharing in the future, subject to investigator review and in accordance with institutional policies, research ethics board requirements, and participant consent provisions, with appropriate safeguards to protect participant confidentiality.

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.

    PubMed 24279835

  • Hsieh HF, Shannon SE. Three approaches to qualitative content analysis. Qual Health Res. 2005 Nov;15(9):1277-88. doi: 10.1177/1049732305276687.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 10940958

  • Creswell JW, Clark VLP. Designing and conducting mixed methods research. Sage publications; 2017.

  • 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.

    PubMed 19362699

  • Dimitropoulos G, Nicula M, Krishnapillai A, Austin A, Singh M, Lee J, Webb C, Scott S, de Almeida ACV, Bergmann C, Vander Steen H, Kimber M, Mushquash C, Norman L, Sauerwein J, Keshen A, Boachie A, Toulany A, Levinson A, Federici A, Allemang B, Ford C, Katzman DK, Tam E, McVey G, Steiger H, Scarborough J, Coelho JS, Thannhauser J, Geller J, Darnay K, Henderson J, Bright K, Soper K, Isserlin L, Booij L, Brouwers M, Laliberte M, Jericho M, Obeid N, Smith S, Grewal S, MacEachern S, Findlay S, Preskow W, Spettigue W, Maharaj A, Wozney L, Iyer S, Norris M, Vallianatos H, Jones S, Lacroix E, Ferrari M, Steinegger C, Loewen T, Gusella J, LeClerc A, Johnson N, Phillips S, Patton M, Punjwani Z, Greer K, Bhatnagar N, Couturier J. Transitions for youth and young adults with eating disorders and/or other mental health conditions: a Canadian guideline. J Eat Disord. 2025 Jul 28;13(1):158. doi: 10.1186/s40337-025-01343-6.

    PubMed 40722124

  • Dimitropoulos G, Singh M, Mushquash C, Kimber M, Hutt-MacLeod D, Moore EK, Perri A, Webb C, Norman L, Sauerwein J, Nicula M, Couturier J. TransitionED: A protocol for Co-designing and implementing Canadian practice guidelines for transitions for youth with eating disorders. Eur Eat Disord Rev. 2025 Nov;33(6):1175-1189. doi: 10.1002/erv.3026. Epub 2023 Sep 10.

    PubMed 37690096

  • 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. Front Psychiatry. 2021 May 26;12:624942. doi: 10.3389/fpsyt.2021.624942. eCollection 2021.

    PubMed 34122164

  • Dimitropoulos G, Toulany A, Herschman J, Kovacs A, Steinegger C, Bardsley J, Sandhu S, Gregory C, Colton P, Anderson J, Kaufman M. A qualitative study on the experiences of young adults with eating disorders transferring from pediatric to adult care. Eat Disord. 2015;23(2):144-62. doi: 10.1080/10640266.2014.976106. Epub 2014 Nov 17.

    PubMed 25402167

  • Dimitropoulos G, Tran AF, Agarwal P, Sheffield B, Woodside B. Navigating the transition from pediatric to adult eating disorder programs: perspectives of service providers. Int J Eat Disord. 2012 Sep;45(6):759-67. doi: 10.1002/eat.22017. Epub 2012 Mar 19.

    PubMed 22431280

  • Treasure J, Schmidt U, Hugo P. Mind the gap: service transition and interface problems for patients with eating disorders. Br J Psychiatry. 2005 Nov;187:398-400. doi: 10.1192/bjp.187.5.398.

    PubMed 16260812

Questions about this trial

What is this clinical trial studying?

A study testing TransitionED Healthcare Transition Framework in people with Eating Disorders in Adolescence and Transition of Care, run by McMaster University at 2 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jennifer Couturier, MD, MSc (905-521-2100 ext. 76035, coutur@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Acceptability (time frame: Post-intervention (approximately 8 weeks after enrollment) and at 6-month follow-up.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07518641, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.

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