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ClinicalTrials.gov ID

NCT07518641

Lead Sponsor

McMaster UniversityOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

60Estimated

Last Update Posted

Apr 8, 2026Actual

Start Date

May 2026Estimated

Primary Completion Date

Mar 2028Estimated

Completion Date

Mar 31, 2028Estimated

Official Title

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

Brief 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. 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.

• Eating Disorders in Adolescence
• Transition of Care

• TransitionED Healthcare Transition Framework

Ages Eligible for Study

Child (0-17)Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

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.

Primary Purpose

Health Services Research

Allocation

N/A

Interventional Model

Single Group Assignment

Masking

None (Open Label)

Lead Sponsor

McMaster UniversityOTHER

Collaborators

University of CalgaryOTHER

Canadian Institutes of Health Research (CIHR)OTHER_GOV

McMaster Children's HospitalOTHER

coutur@mcmaster.ca905-521-2100 ext. 76035