Pilot Feasibility Trial of a Peer Support Program for Trauma Survivors
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSunnybrook Health Sciences Centre
About this trial
Traumatic injuries from events like car crashes, falls, or fires are a leading cause of disability. Survivors often face not only physical challenges but also long-lasting pain, mental health challenges and difficulty returning to work and family life. Although medical care focuses on physical recovery, survivors frequently report that their emotional and social needs are overlooked and unmet.
Peer support-guidance from people who have lived through similar injuries-can reduce distress and improve coping. However, no programs in Canada currently provide peer support to trauma survivors across their recovery journey, from hospital to rehabilitation to community living.
The investigators worked with trauma survivors, caregivers, and healthcare providers to co-design a Peer Support Program (PSP) that offers support throughout these stages. This pilot study will test whether the program is feasible and acceptable, and explore its early impact on recovery. Results will guide a future larger trial to expand peer support in trauma care.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
adult patients (18 years+) who have experienced an unintentional traumatic injury resulting in hospitalization at Sunnybrook and who will be discharged to inpatient rehabilitation at St. John's Rehab after acute care.
must be able to communicate in English
Disqualifiers
patients who experienced: a) an intentional self-harm injury (because self-harm suggests a history of mental health issues prior to the trauma requiring specific psychiatric supports)
patients who experienced: an injury caused by an intimate partner (because these injuries are typically underpinned by chronic exposure to domestic violence which requires interventions that promote patient safety and interrupt the pattern of violence)
patients who experienced: a violently-acquired injury (as this patient population already receives specific clinical and social support through Sunnybrook's BReAking the Cycle of Violence with Empathy (BRAVE) program).
patients with substantial cognitive impairment and a history of substance misuse if their HCPs indicate that either condition will impede the their ability to provide informed consent and/or participate safely in the trial
Trial design
Design model
Single group
Treatments tested in this trial
Cross-continuum Peer Support Program
BehavioralTrained trauma-survivor peer supporters (n=4), supported by a research team member; peers complete a 5-session training covering trauma-informed communication, boundaries, crisis de-escalation, self-care, and secondary trauma. Trauma survivors will be recruited in acute care and have the option to meeting once with a trained peer supporter prior to discharge to inpatient rehabilitation. In in-patient rehab they will attend 1 hour peer support group sessions facilitated by the trained peer supporters twice a week for a total of 3 weeks. Once discharged the community, they will attend 1 hour peer support group sessions facilitated by the trained peer supporters once a week for a total of 12 weeks.
Treatment groups
49 Participants
are divided into 1 treatment groupGroup A: Single-arm pilot feasibility studyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Feasibility of implementing the Peer Support Program
To determine the feasibility of implementing the Peer Support Program (PSP) for trauma survivors. We will measure the criteria below to establish feasibility. These feasibility goals were established with reference to another study our group conducted aimed at assessing the feasibility of a novel psychosocial group intervention for amputees. * RECRUITMENT (proportion of eligible participants approached who consent-GOAL: ≥50%), * WITHDRAWAL (proportion of study participants who withdraw from the study before the end of Phase II (Inpatient Rehabilitation)-GOAL: ≤ 25%) * ADHERENCE (proportion of PSP sessions attended by participants-GOAL: ≥60%), * RETENTION (proportion of participants who complete the program-GOAL: ≥60%); * BASELINE SURVEYS (proportion of surveys completed-GOAL: ≥70%). * POST-INTERVENTION SURVEY (proportion of surveys completed-GOAL: ≥60%): * SURVEY AT 3 MONTH FOLLOW UP (proportion of surveys completed-GOAL: ≥50%):
Time frame
From recruitment to 3 months post interventionSecondary outcomes
1
Community Reintegration - Normal Living Index (RNL) Index
The 11-item Reintegration to Normal Living Index (RNL) Index covers areas such as involvement in recreational and social activities, perceived ability to move within the community, and the degree of comfort people have with their relationships. It is a valid and reliable tool for assessing participation in various populations. Scores range from 0 to 110, with a higher score indicating a higher level of community reintegration.
Time frame
Baseline, up to 2 weeks post intervention, and 3-months post intervention2
Coping Self-Efficacy (CSE) - 20-item CSE Scale
The 20-item CSE Scale66 is a coping self-efficacy scale that has a robust factor structure across different types of post-traumatic events, making it especially suitable for use in various trauma populations. For each item, respondents rate their perceived efficacy on dealing with different consequences of trauma on a 7-point scale (e.g. 'resuming normal life'; 'being optimistic since the event'). Scores range from 20 (low self-efficacy) to 140 (high self-efficacy). The internal consistency of the scale has been found to be excellent across three panel waves of data in persons who had experienced a traumatic event in the previous two years
Time frame
Baseline, up to 2 weeks post intervention, and 3-months post intervention3
Health-Related Quality of Life - The Short-Form 36 (SF-36)
The Short-Form 36 (SF-36) is the most widely used generic health-related QoL instrument, including Neuro-musculoskeletal injuries, which measures 8 multi-item dimensions of health: physical functioning, social functioning, role limitations due to physical and emotional problems, mental health, energy/vitality, pain, and general health perception. Scores range from 0 to 100 on each domain, with lower scores indicating poorer function. These eight dimensions are summarized into a physical and mental health summary score. The SF-36 is sensitive to changes in functioning over time, and has demonstrated clinically meaningful, albeit modest, change in trauma patients.
Time frame
Baseline, up to 2 weeks post intervention, and 3-months post intervention4
Post-Traumatic Stress Disorder (PTSD) - The PTSD Checklist-Civilian Version (PCL-C)
The PTSD Checklist-Civilian Version (PCL-C) is a standardized 17-item self-report rating scale for PTSD that is well-validated across different populations. Respondents indicate how much they have been bothered by a symptom over the past month using a 5-point scale, with higher scores indicating more severe levels of PTSD.
Time frame
Baseline, up to 2 weeks post intervention, and 3-months post interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Sunnybrook Health Sciences Centre
Lead sponsor
Canadian Institutes of Health Research (CIHR)
Collaborator
Source ClinicalTrials.gov
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