Eating Disorders Clinical Trial
Official title:
Examining the Impact of Peer Mentors on Individuals Transitioning to Adult Eating Disorder Treatment: A Feasibility Study
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 |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Canada | Abbie J Lane Memorial Building - QEII | Halifax | Nova Scotia |
Lead Sponsor | Collaborator |
---|---|
Nova Scotia Health Authority |
Canada,
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* Note: There are 42 references in all — Click here to view all references
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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