Clinical trials

This project involves developing and piloting a peer-led intervention focused on posttraumatic stress symptoms for the family members and significant others of people with borderline personality disorder. The project involves collaborating with The Sashbear Foundation who will be delivering the trauma response program (TRP) that was developed by the investigative team to its network. In phase 1 of this project, the investigators will evaluate the first delivery of the TRP at The Sashbear Foundation and solicit feedback from peer-facilitators and recipients who consent to research participation. In phase 2 of this project, the investigators will evaluate the efficacy, acceptability, and safety of the delivery of the next two to four TRPs delivered at The Sashbear Foundation consisting of up to approximately 10 group members (maximum number of TRP recipient research participants in phase 2 is 40).

To address the current limitations related to infant pain assessment in the NICU, our international team of knowledge users and health/natural science/engineering/social science researchers have come together to build a machine learning algorithm that will learn how to discriminate invasive and non-invasive distress. Furthermore, to improve the use of current pain management practices, our team seeks to better understand the developmental mechanisms underlying skin-to-skin contact over time and factors that may influence its efficacy in mitigating pain responses in preterm infants. This is an ongoing naturalistic observational study.

Millions have developed Long COVID (LC), and recent findings show an association between taurine deficiency (an amino acid) and symptoms in LC. Cost-effective and accessible interventions are needed to improve welfare and reduce healthcare costs. We will investigate the efficacy of 12-weeks of taurine supplementation (self-administered), on vascular function and the cardio/cerebrovascular responses to upright posture. We will measure resting vascular function with an EndoPAT device, resting heart rate variability, and the blood pressure, heart rate, and brain blood flow responses to 5 minutes of head-up tilt before and after weeks of taurine supplementation in LC. We hypothesize that the 12 weeks of supplementation will improve both resting vascular function and the responses to upright tilt. In turn, we hypothesize that symptoms will also improve (as measured by questionnaires).

The purpose of this study is to determine whether 12 weeks of exercise training combined with dairy consumption influences inflammation and immune responses in adults with overweight, compared to exercise training alone.

Borderline personality disorder (BPD) is a life-threatening, costly public health crisis affecting \~1-3% of North Americans, with 10% dying by suicide and annual healthcare costs of \~$63k (Canadian Dollars)/patient. Further, people with BPD's intimate relationships are highly disrupted, and their partners report elevated mental health problems but little access to treatment. Existing BPD treatments are resource-heavy, inaccessible, and 47% of people with BPD do not respond to them. These treatments also neglect relationship problems and intimate partner's mental health concerns, even though they are thought to play a key role in BPD maintenance. BPD interventions may produce stronger, quicker, and more durable outcomes if they incorporated partners to target both the emotional and relationship core of BPD. Moreover, incorporating partners into interventions may improve relationship outcomes and partner mental health without added resource investments. Accordingly, members of our team developed Sage. Named after a plant that thrives in relationship with its ecosystem, Sage is a brief, 12-session conjoint intervention for people with BPD and their intimate partners that targets BPD, relationship conflict, and partner mental health. Our recent uncontrolled trial provides preliminary support for its efficacy. As a next step in testing Sage, it is critical to utilize a Randomized Controlled Trial (RCT) design to identify if Sage is more efficacious than standard care that these couples typically receive; supportive individual psychotherapy (SIP) for people with BPD and their partners. The investigators propose to conduct the first RCT of Sage for couples wherein one member has BPD. The study will examine if Sage is more efficacious than SIP in improving BPD symptoms (primary outcome), as well as relationship conflict and partner mental health (secondary outcomes), as well as a range of other outcomes, from pre- to post-intervention, and post-intervention to follow-up. It will also investigate factors that influence treatment response, BPD severity, and related problems. Up to 152 couples wherein one member has BPD will be randomized to receive Sage or SIP. Gold-standard measures of primary, secondary, and exploratory outcomes will be administered at baseline, mid-intervention, post-intervention, and a one-month, three- month, and six-month follow-up.

Background. Emerging adulthood is a period of major change in young people's lives, including increased independence, new responsibilities, and shifting relationships with parents or caregivers. During this time, disagreements between emerging adults and caregivers are common and may become more frequent or emotionally intense. How families manage these disagreements may affect relationship quality and emotional well-being for both emerging adults and caregivers. However, there are few brief, accessible programs designed to support emerging adults and caregivers together during this transition. Grow Together, Thrive Together (G2T2) is a brief, online, writing-based relationship program designed for emerging adults and their caregivers. The program encourages participants to reflect on disagreements using a neutral, outside-observer perspective, with the goal of helping families approach conflict in healthier ways. G2T2 is designed to be low-intensity, self-directed, and accessible, and can be completed remotely using secure online platforms. The purpose of this study is to evaluate the feasibility and acceptability of the G2T2 program and study procedures, rather than to test effectiveness. This feasibility clinical trial will examine whether emerging adult-caregiver dyads can be successfully recruited and retained, whether participants complete the writing sessions as planned, and whether participants find the program acceptable, easy to use, and understandable. The study will also explore whether participants report using the conflict reappraisal strategy outside of the writing sessions and examine changes in relationship and conflict-related outcomes before and after the program to inform future research. Participants will take part as emerging adult-caregiver pairs. Each participant will complete an online baseline survey, three brief online writing sessions completed over approximately nine weeks, and a follow-up survey one week after the final session. Each writing session includes brief questions about recent disagreements, a short instructional video, brief questions to check understanding of the strategy, and guided writing exercises focused on reflecting on disagreements and planning how to use the strategy in future interactions. All activities are completed independently and online. Findings from this study will be used to refine the G2T2 program and study procedures and to inform the design of a future, larger randomized controlled trial.

Background. Understanding emotions, stress, and conflicts within the family context is critical for promoting positive change. However, most support services for families often address child development, parenting, couple relationships separately without considering these as interacting systems that contributes to overall family well-being. This project is to evaluate an existing clinical service in York University Psychology Clinic (YUPC), "Building Blocks for Child and Family Well-being" (BBFW), which provides an integrated understanding of the family context, and equips caregivers with tools to help families connect, problem-solve, cope with stress, and thrive. BBFW is a brief virtual program that promotes experiential learning, provides individually tailored strategies, and builds a community of support for caregivers. The current study aims to examine the feasibility, acceptability, and effectiveness of the BBFW program within the York University Psychology Clinic (YUPC), with four objectives: 1. Evaluating the feasibility of implementing the BBWF program into YUPC clinical services, represented by enrolment rates, sample characteristics, retention (i.e., number of sessions attended, % dropout), adherence (i.e., completing in- and out-of-session activities), as well as the acceptability of the program among participants. 2. Examining sample and clinical characteristics of those attending the BBFW service 3. Exploring the effectiveness of the BBFW program through changes in family functioning and meta-emotion philosophy from pre- to post-intervention, as well as changes at 1- and 3-month follow-ups. 4. Evaluating and refining the program quality using participant quantitative and qualitative feedback. The BBFW program is based on the best evidence from developmental, family, and relationship science. It aims to support family mental health and well-being through a holistic and sustainable approach, viewing the family as a set of multiple, interdependent systems. This program provides a brief, cost-effective, and accessible alternative with the potential to reduce the burden on traditional mental health and support services for Canadian families.

Background. Children are vulnerable to mental health challenges during development. Given that youth are reliant on their parents for support, understanding the child's symptoms within the family context is critical for promoting positive change. This proposal focuses on "systemic therapy", or family-based therapy, which seeks to enhance children's mental health by improving the relationships and communication between family members (1). Most family-based therapies for treating child mental health problems are intense in duration and frequency (2), which is a barrier to access for many families. Shorter-term family therapies or what will be referred to hereafter as brief family-based therapies are effective in treating a variety of child symptoms, while also minimizing participant burden and therapy dropout (3). One type of brief family-based therapy model is the Lausanne Family Play - Brief (LFP-B), a three-session service that utilizes a play-based family observational assessment with video feedback to draw attention to and catalyze change in challenging family interactions. The LFP has been widely researched as a clinical assessment tool and has been implemented as a brief family-based therapy program (4). The current project represents the implementation and evaluation of the program in the York University Psychology Clinic (YUPC), which services children, adults, couples, and families in the Greater Toronto Area (and Ontario, broadly). The current study will be the first to evaluate the implementation, acceptability, and effectiveness of the LFP-B as a clinic service. Objectives. The aim of this project is to evaluate the LFP-B as a brief family-based clinical service offered in the YUPC. The first objective is to explore program acceptability for both clients and therapists. The investigators are interested in whether clients and therapists are satisfied with this clinical service and its processes. The second objective is to assess program effectiveness, specifically whether coparenting, family functioning, and child mental health problems improve across the course of the program and in the months following. Importance. Brief therapies with a systemic lens can increase cost-effectiveness, accessibility, and treatment retention. They also have potential to fill an apparent gap in service needs as up to three-quarters of youth with psychological concerns never receive treatment (5). Thus, brief services can provide more timely access to mental health care in Canada which have potential for reducing wait times, preventing further deterioration in mental health, and avoiding more intensive and expensive higher levels of care (e.g., acute inpatient mental health services; (6)). The LFP-B has potential to be widely used as a brief family-based therapy program with Canadian families to support child and family functioning in a timely and non-intensive manner.

This study seeks to understand the effects of adult day programs on older adults, especially those with dementia, and their caregivers. A prospective cohort study will be conducted in the Canadian provinces of Alberta, British Columbia, Manitoba, and Ontario. Participants will be (1) older adults with dementia who attend a day program, and their caregivers, and (2) older adults with dementia in the community who do not attend a day program, and their caregivers. The objectives are to (1) evaluate the effects of day programs on attendee and caregiver outcomes, and (2) compare day program use patterns, attendee and caregiver social identities, day program characteristics, and day program outcomes between the 4 provinces, and (3) to explore what attendee and caregiver social identities and day program characteristics are associated with study outcomes, and with day program attendance/non-attendance.

This study seeks to understand the impact of Canada's adult day program on attendees and non-attendees, especially those with dementia and other co-morbidities. A retrospective cohort study will be conducted, including older adults in the community who do or do not attend adult day programs in Alberta, British Columbia, and Manitoba, Canada. The objectives are to (1) compare patterns of day program use (including non-use) by Canadian province (Alberta, British Columbia, Manitoba), and time, (2) compare characteristics of older adults by day program use pattern (including non-use), province, and time, and (3) to examine whether those who are exposed to day programs, compared to a propensity-score matched comparison group of non-exposed older adults in the community, enter long-term care homes at later times (primary outcome), are less likely to have depressive symptoms, physical and cognitive change, and have lower use of primary, acute, and emergency care (secondary outcomes).

An important question in education is how to help young children who struggle to learn to read despite being well-taught in their regular classrooms. Many of the children with low reading ability also come from disadvantaged backgrounds. There is not a lot of evidence on how to support children with low reading ability become better readers. This is especially true when children still have low reading ability despite experiencing attempts to teach them in both their regular whole class and then in small groups. As a result, in this study we will explore the best ways of training teachers to use programs that we have developed to support reading for these children who have not responded well to earlier teaching (this is one of the tough jobs in our project title). These programs have several new elements. One element is teaching morphology. Morphology means shared word meanings such as the shared meanings between words like sign, design, signal, and signature. Another element is called set-for-variability. This means teaching children to have mental flexibility in using relationships between letters and sounds to read English. We will run our study to see whether including these new elements leads to children with low reading ability improving their reading. By doing this we will help children teachers and families and also contribute to a science of reading. To achieve these goals, we will carry out two phases of study. In phase 1, we will randomly allocate 50 schools to one condition where we will teach morphology and 50 schools to the other condition where we will teach set-for-variability. In all schools we will also encourage teachers to teach children to use the relationships between letters and sounds to read words. This is called phonics. Doing such work and still having impact in a large number of schools is a major challenge. This is the second of the tough jobs referred to in our project title. In each school we will come in and train teachers of grade 1 and 2 children how to use our programs, and focusing on the children who have low reading ability. In the second part of the study, we will work with a smaller set of children in Grade 3 who still have low reading ability despite our earlier work. In this latter case the groups of children may be both smaller in number and the teaching may go on for longer to have an effect.