NCT05543044

Brief Summary

Participants will be males and females aged 16-24 with an eating disorder (ED) diagnosis who are transitioning to adult-oriented ED treatment in Nova Scotia, New Brunswick, or Prince Edward Island. Youth participants will be recruited from community-based clinics, hospital programs, and private practices where ED treatment is delivered. Youth who are interested in participating and provide written consent will be invited to take part in a screening meeting to determine eligibility to participate. Eligible participants will be paired with a peer mentor for a 3-6 month intervention to guide them through the transition to adult-oriented ED treatment. Participants will be asked to complete questionnaire packages before beginning the intervention, after completing the intervention, and 12 months after beginning the intervention. Some youth participants, as well as some of their carers and the peer mentors, will be asked to participate in one-on-one interviews about their experiences with transitions in ED care and the peer mentor intervention. The investigators are conducting this study to determine whether the use of peer mentors is an effective and acceptable means of transition support for youth with EDs. The investigators are also interested in better understanding the experiences of carers and peer mentors who are supporting youth with EDs during their transition in care.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
10mo left

Started Mar 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress80%
Mar 2023Mar 2027

First Submitted

Initial submission to the registry

September 9, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 16, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

March 28, 2023

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 5, 2027

Expected
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

March 19, 2026

Status Verified

June 1, 2025

Enrollment Period

3.9 years

First QC Date

September 9, 2022

Last Update Submit

March 17, 2026

Conditions

Keywords

Eating DisordersPeer MentorsYouthFeasibility

Outcome Measures

Primary Outcomes (1)

  • Change in Autonomous Motivation

    This will be measured at Baseline, Post-Intervention, and 12-Month Follow-Up, using The Treatment Self-Regulation Questionnaire (TSRQ; Levesque et al., 2007). The TSRQ is a reliable and valid self-report questionnaire that assesses the type of motivation patients use (autonomous or external/controlled) when engaging in a health behaviour or treatment. The TSRQ consists of 12 questions with scores ranging from 1 ("strongly disagree") to 7 ("strongly agree"). The TSRQ can be modified to measure specific health care outcomes (e.g., ED related). Further, the TSRQ has previously been used to detect changes in autonomous motivation before and after health-related interventions, including over six-month timeframes (e.g., Stamp et al., 2016; Knittle et al., 2015). A recent scoping review determined that there are no validated quantitative measures for specifically evaluating mental health related transition interventions for TAY (Cleverly et al., 2018).

    Baseline, 3-6 months, 12 months

Secondary Outcomes (2)

  • Completed Transitions

    12 months

  • Patient acceptability

    Throughout study completion, 12 months

Other Outcomes (3)

  • Change in eating disorder symptomatology

    Baseline, 3-6 months, 12 months

  • Change in clinical impairment

    Baseline, 3-6 months, 12 months

  • Change in feelings of competence about participating in eating disorder treatment

    Baseline, 3-6 months, 12 months

Study Arms (1)

TAY receiving peer mentor intervention

EXPERIMENTAL

Transition age youth with EDs (n=50) will receive a peer mentor delivered transition intervention

Behavioral: Peer mentor intervention

Interventions

Peer mentor delivered intervention for transitions to adult-oriented treatment for eating disorders

TAY receiving peer mentor intervention

Eligibility Criteria

Age16 Years - 24 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Meets one of the following criteria:
  • 'Aging out' of youth-oriented ED treatment at 19 years-old and unlikely to achieve remission prior to leaving the program (as determined by their clinician\[s\])
  • Have been deemed incompatible with traditional youth-oriented ED treatment (based on established youth-oriented ED treatment criteria, and determined by their clinician\[s\])
  • Have requested and/or had a carer request a transition to adult-oriented ED treatment
  • Have been self-referred or referred to adult ED treatment by a clinician (even if they have not been involved in youth-oriented ED treatment)
  • Aged 16-24 years old
  • Meets criteria for DSM-5 diagnosis of an ED, as confirmed by the Structured Clinical Interview for DSM-5 Research Version (SCID-5-RV)
  • Virtually signed informed consent form

You may not qualify if:

  • Insufficient knowledge of English
  • Moderate to high suicide risk rating at screening as assessed by the Columbia Suicide Severity Rating Scale (CSSRS; at the discretion of the PI)
  • Identified by a TAY participant as a carer
  • Aged 18 or older
  • Virtually signed informed consent form
  • Insufficient knowledge of English
  • Certified PM with EDNS
  • Providing PM support to TAY study participants
  • Virtually signed informed consent form
  • Insufficient knowledge of English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Abbie J Lane Memorial Building - QEII

Halifax, Nova Scotia, B3H 2E2, Canada

Location

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MeSH Terms

Conditions

Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Aaron K Keshen

    Nova Scotia Health Authority

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Aaron Keshen, MD, FRCPC

Study Record Dates

First Submitted

September 9, 2022

First Posted

September 16, 2022

Study Start

March 28, 2023

Primary Completion (Estimated)

February 5, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

March 19, 2026

Record last verified: 2025-06

Locations