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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05543044
Other study ID # 1028566
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 28, 2023
Est. completion date March 1, 2026

Study information

Verified date February 2024
Source Nova Scotia Health Authority
Contact Aaron K Keshen, MD,FRCPC
Phone (902)473-6288
Email Aaron.Keshen@nshealth.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

This feasibility study will incorporate quantitative and qualitative methods and utilizes an uncontrolled pretest-posttest quasi-experimental design to examine the effectiveness and acceptability of a peer mentor delivered intervention that aims to improve transitions to adult-oriented care for patients with eating disorders (EDs) aged 16-24. Youth will be recruited from community-based clinics, hospital programs, and private practices where youth- or adult-oriented ED treatment is delivered across Nova Scotia, New Brunswick, and Prince Edward Island. Clinicians in these settings will be asked to identify potentially eligible youth who will be transitioning to adult-oriented ED care. Potential participants who are interested in participating and provide written consent will meet with a research team member for a screening meeting to determine their eligibility status. Screening will involve the Structured Clinical Interview for DSM-5 Research Version (SCID-5-RV) and the Columbia Suicide Severity Rating Scale (C-SSRS). All screening information will be reviewed by the PI (Dr. Keshen). Participants who are not interested in the study or who fail to meet the eligibility criteria will be given standard options available to treatment age youth. Youth participants who are found eligible will be connected with a trained peer mentor for a 3-6 month transition intervention. Youth and their peer mentor will meet weekly, bi-weekly, or monthly depending on the phase of the intervention and the needs of the youth. The intervention is divided into 3 phases: phase 1 includes building a sense of trust, rapport, and motivation, as well as the identification of goals, strengths, challenges and barriers related to transition; phase 2 focuses on self-reflection, problem-solving, and transition planning; and phase 3 involves the gradual tapering off and conclusion of the peer mentor relationship. Youth 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 will also be asked to participate in one-on-one interviews with a research team member at these same time-points. Some youth participants will be asked if they would like to involve a carer in the study, as well. Carers will be invited to participate in a one-on-one interview with a research team member 12 months after the youth they are caring for began the intervention. Peer mentors will be invited to participate in one-on-one interviews at the end of the study. The aim of the interviews is to understand experiences with eating disorder treatment, transitions in care, and the peer mentor intervention.


Recruitment information / eligibility

Status Recruiting
Enrollment 49
Est. completion date March 1, 2026
Est. primary completion date March 1, 2026
Accepts healthy volunteers No
Gender All
Age group 16 Years to 24 Years
Eligibility TAY Inclusion Criteria: - 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 TAY Exclusion Criteria: - 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) Carer Inclusion Criteria: - Identified by a TAY participant as a carer - Aged 18 or older - Virtually signed informed consent form Carer Exclusion Criteria: • Insufficient knowledge of English PM Inclusion Criteria: - Certified PM with EDNS - Providing PM support to TAY study participants - Virtually signed informed consent form PM Exclusion Criteria: • Insufficient knowledge of English

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Canada Abbie J Lane Memorial Building - QEII Halifax Nova Scotia

Sponsors (1)

Lead Sponsor Collaborator
Nova Scotia Health Authority

Country where clinical trial is conducted

Canada, 

References & Publications (42)

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Dimitropoulos G, Tran AF, Agarwal P, Sheffield B, Woodside B. Challenges in making the transition between pediatric and adult eating disorder programs: a qualitative study from the perspective of service providers. Eat Disord. 2013;21(1):1-15. doi: 10.1080/10640266.2013.741964. — View Citation

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Griffiths S, Mond JM, Murray SB, Touyz S. The prevalence and adverse associations of stigmatization in people with eating disorders. Int J Eat Disord. 2015 Sep;48(6):767-74. doi: 10.1002/eat.22353. Epub 2014 Sep 5. — View Citation

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Hanly F, Torrens-Witherow B, Warren N, Castle D, Phillipou A, Beveridge J, Jenkins Z, Newton R, Brennan L. Peer mentoring for individuals with an eating disorder: a qualitative evaluation of a pilot program. J Eat Disord. 2020 Jul 1;8:29. doi: 10.1186/s40337-020-00301-8. eCollection 2020. — View Citation

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Jones BA, Haycraft E, Bouman WP, Brewin N, Claes L, Arcelus J. Risk Factors for Eating Disorder Psychopathology within the Treatment Seeking Transgender Population: The Role of Cross-Sex Hormone Treatment. Eur Eat Disord Rev. 2018 Mar;26(2):120-128. doi: 10.1002/erv.2576. Epub 2018 Jan 10. — View Citation

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McClelland J, Hodsoll J, Brown A, Lang K, Boysen E, Flynn M, Mountford VA, Glennon D, Schmidt U. A pilot evaluation of a novel First Episode and Rapid Early Intervention service for Eating Disorders (FREED). Eur Eat Disord Rev. 2018 Mar;26(2):129-140. doi: 10.1002/erv.2579. — View Citation

McClelland J, Simic M, Schmidt U, Koskina A, Stewart C. Defining and predicting service utilisation in young adulthood following childhood treatment of an eating disorder. BJPsych Open. 2020 Apr 6;6(3):e37. doi: 10.1192/bjo.2020.13. — View Citation

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* Note: There are 42 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Other Change in eating disorder symptomatology This will be measured at Baseline, Post-Intervention, and 12-Month Follow-Up, using the Eating Disorder Examination Questionnaire (EDE-Q; Fairburn & Beglin, 1994), a validated and reliable 28-item self-report questionnaire. Baseline, 3-6 months, 12 months
Other Change in clinical impairment This will be measured at Baseline, Post-Intervention, and 12-Month Follow-Up, using the Clinical Impairment Assessment (CIA; Bohn & Fairburn, 2008), which is a reliable and validated 16-item self-report questionnaire that measures functional impairment over the last 28 days. Higher scores on the CIA indicate more impairment. Baseline, 3-6 months, 12 months
Other Change in feelings of competence about participating in eating disorder treatment This will be measured at Baseline, Post-Intervention, and 12-Month Follow-Up using the Perceived Competence Scale (PCS; Williams et al., 1995), a companion scale in a questionnaire package that includes the TSRQ. The PCS is a valid and reliable tool that evaluates feelings of competence about participating in a health behaviour or treatment. The PCS is a 4-item self-report questionnaire with scores ranging from 1 ("not at all true") to 7 ("very true"). Baseline, 3-6 months, 12 months
Primary 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 Completed Transitions Engagement in adult-oriented service could include: a) one session (or more) of individual psychotherapy aimed at treating the ED (as determined by the PI); b) an admission into AEDP (i.e., group-based Day Program or Inpatient); and c) the youth is on the wait-list to start adult treatment. Initiation of adult services can be through referral from any clinician or self-referral. Although our measurement of a completed transition is a dichotomous variable, we will also collect exploratory data to examine the degree of service uptake in the adult-oriented treatment (low, medium, and high use as defined by McClelland et al., 2020). This will allow us to explore not only whether the youth transitioned or not, but also to what degree they engaged in an adult service after the transition. 12 months
Secondary Patient acceptability This will be measured at Baseline, Post-Intervention, and 12-Month Follow-Up, using the Health Care Climate Questionnaire (HCCQ; Williams, et al., 1996) at Baseline, Post-Intervention, and 12-Month Follow-Up. The HCCQ measures the extent to which patients feel that providers take full account of their perspective, offer choice and information, encourage self-initiation, provide rationale, and accept patient decisions. The HCCQ is a companion scale to the TSRQ, and has been positively associated with autonomous motivation and treatment adherence (Williams et al., 2006; Chan et al., 2009). The HCCQ is a valid and reliable 6-item self-report questionnaire with scores ranging from 1 ("strongly disagree") to 7 ("strongly agree"). Throughout study completion, 12 months
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