Clinical Research Directory

Online Learning Module to Advance Research Related to People With Disabilities

This study will measure the effects of a brief one-time eLearning intervention on researcher Knowledge, Attitudes, and Perceptions (KAP) of including people with disabilities (PWDs) in biomedical \& behavioral research. Researchers will be recruited from across the Einstein/Montefiore network, and other medical centers with a focus on CTSAs.

Health Engagement & Access Through Learning, Training, and Health-coaching With People With Intellectual and/or Developmental Disabilities

The purpose of this study is to see if a combination of an educational curriculum and health coaching embedded within Special Olympics improves health outcomes and healthcare access compared to regular Special Olympics sport and health programming for adults with intellectual and/or developmental disabilities.

Behavioral Parent Training to Address Early Childhood Disruptive Behavior Using the Helping Our Toddlers, Developing Our Children's Skills (HOT DOCS) Program and the Developing Our Children's Skills Kindergarten-5th Grade (DOCS K-5) Program

HOT DOCS and DOCS K-5 are group-delivered behavioral parent training interventions for caregivers of children ages 0-12 years.

Comparing the Impact of Peer Support vs. Staff-Delivered Transportation Interventions for Young Adults With Intellectual and Developmental Disabilities.

This clinical trial will look at whether young adults with intellectual and developmental disabilities (YA-IDD) have better outcomes when a travel training intervention called Ready to Ride (R2R) is taught by a specially trained Peer Supporter (PS) who shares the lived experience of having an IDD than YA-IDD who are taught Ready to Ride by staff at their community services organization. The aspects of life being looked at are loneliness, satisfaction with social activities, travel skills, service use and access, employment, and health related quality of life. The researchers think the following things will happen. 1. YA-IDD who learn from a Peer Supporter will report significantly higher satisfaction with social activities, increased social connectedness and significantly less loneliness compared to YA who are taught organization staff. 2. Both groups will learn the same amount of travel skills. 3. YA-IDD who learn from a Peer Supporter will show larger increases in access to community-based services, transportation use, employment and health related services after 4 months than the YA taught by organizational staff.

Metformin for Antipsychotic-induced Weight Gain in Adults With Intellectual Disability

People with IDD (intellectual and developmental disability) have very high rates of obesity and die prematurely from cardiometabolic disease. While antipsychotics contribute to this problem, their use is necessary and appropriate in a significant subgroup of individuals with IDD. Exercise and diet interventions have limitations and may not be sufficient, requiring effective adjunctive pharmacological approaches to target obesity and related comorbidities in IDD. However, persons with IDD treated with antipsychotics are systematically excluded from clinical trials hindering development of evidence to help guide safe and effective treatment of these comorbidities. Moreover, evidence from other disorders cannot be extrapolated to IDD given inherent biological differences between disorders. This trial will address the identified gaps, which extend beyond cardiovascular morbidity and negatively impact psychosocial outcomes, in a hugely underserviced population.This is the the first RCT (randomized control trial) to examine the efficacy of metformin in overweight or obese adults with IDD who have experienced antipsychotic-induced weight gain. By generating efficacy data for a very accessible and scalable intervention, allows for guideline and implementation strategies to address a recalcitrant health problem.

Evaluation of the Transitional and Lifelong Care Program

The population cared for in the Transitional and Lifelong Care (TLC) clinic is youth and adults with childhood-onset disability, of which the large majority are adults with brain-based, neurodevelopmental conditions such as cerebral palsy, spina bifida and developmental disability. The TLC program was created to address the health inequities that have long existed for this population because of the gaps in care they experience once they transition from pediatric healthcare services to the adult healthcare sector. The TLC program offers coordinated and comprehensive management of co-occurring mental, social and physical health conditions for this group of adults with neurodiverse conditions. The proposed study will provide much needed evaluation of the TLC model as an intervention to provide transitional and lifelong care that reduces the barriers experienced because of the undefined clinic path - potentially more appropriately referred to as a "cliff" by a Freeman et al., (2015) - for these individuals. With appropriate evidence of effectiveness, scaling of the TLC program to other Ontario Health regions and more widely across Canada would improve access healthcare providers who are knowledgeable and competent in the management of physical and mental health conditions for adults with neurodiverse conditions as well as service integration and coordination between social and health sectors. The TLC clinic was co-designed with adults with neurodiverse conditions and health care providers in 2014 and represents a significant and sustainable change in the way healthcare has been delivered for this population in the Ontario Health West region over the last 7 years. More than 750 people have accessed coordinated and comprehensive care from Physiatrists, a Nurse Practitioner, Social Worker, Physiotherapist, Occupational Therapist, Speech Language Pathologist, Registered Dietitian and Rehabilitation Therapist in the TLC program since it began, documenting the effectiveness of this care has the power to re-shape care received for adults with neurodiverse conditions that onset in childhood in Canada.

Evaluating the Impacts of a Single Session of Robot Assisted Gait Training With a Trexo

Early use of robotic gait trainers have shown many benefits, however why these benefits occur and how to maximize them is unknown. There are a few options for how a robotic gait trainer can be used, however, there is not much understanding of how these options impact rehabilitation and compensate for impairments. The investigators aim to evaluate the impacts of as single session of Trexo robotic gait training and the impact of different modes of the Trexo robotic gait trainer. The investigators will evaluate how the different settings impact things like physical activity, walking, brain activity, spasticity, and fatigue. Investigators will arrange for a familiarity and fitting session to start, so that study team members can fit the participant to the Trexo and so that participants can become familiar with the feeling of using the Trexo robotic gait trainer. After the initial fitting sessions, follow up sessions will be completed to evaluate different settings on the Trexo, for example in "endurance" mode (where the robot completes the movements for the participant) and in "strength" mode (where the robot requires some assistance from the participant). Investigators may also test different fitting settings, for example with and without the supportive seat in the Trexo. Only three visits are required (one fitting/familiarity session and two testing sessions), however participants and/or their families may choose to complete more testing sessions if they want to assess other aspects of the training. For example, if the first two testing sessions assessed physical activity, participants and their families may choose to return for further sessions to assess brain activity. The aim of the study is to determine how robot assisted gait training impacts rehabilitation and compensates for impairments, as well as to provide suggestions on how the robotic gait trainer might be improved or modified. This study is exploratory to find out more about how these robotic gait trainers, specifically the Trexo, impacts various aspects of rehabilitation.

Problem Behavior Assessment and Intervention in IDEA Part C Services

The purpose of this study is to evaluate the effect of function-based assessment and intervention to reduce problem behavior in children with developmental disability or delay in the context of IDEA Part C services. The investigators will conduct a single-case study to evaluate the efficacy of the intervention.

Wearable Sensors and Video Recordings to Monitor Motor Development

The objective of this study is to develop an automated, precise, quantitative assay for detecting atypical motor behavior and development in infants using data from wearable sensors and video recordings.

Neurobehavioral Development in Toddlers and Preschoolers in Relation to Prenatal Exposure of Mild Analgesics (NeuroToP - a COPANA Follow up)

Fundamental aspects of both neurological and reproductive function are established in fetal life, and there is a present increased awareness of the potential effects of fetal exposures on neurodevelopmental and reproductive health of offspring. Experimental and epidemiological research studies strongly suggest that paracetamol and NSAID are endocrine disruptive in the fetus, which could increase the risks of some neurodevelopmental, reproductive, and urogenital disorders. In recent years, there has been an increasing rate of neurodevelopmental disorders such as ADHD and autism. The original cohort, the Copenhagen Analgesic Study (COPANA), is the first prospective human study designed primarily to assess the effect of fetal exposure to mild analgesics on male and female reproductive function. If the same children are examined with relevant neurobehavioral testing during mid-childhood, the study design allows the investigators to assess the effect of mild analgesics as well as other EDCs on neurodevelopmental health.

Implementing Powered Mobility in Early Childhood Settings for Children With Cerebral Palsy

The goal of this clinical trial is to learn if a therapist training program can help providers in Part C Early Childhood Settings use powered mobility (PM) with young children who have cerebral palsy (Gross Motor Function Classification System Levels IV-V). The study will also look at whether this training is practical and useful for therapists, families, and children. The main questions it aims to answer are: 1. Can therapists successfully use the training to provide powered mobility interventions in home and early childhood settings? 2. Do families and children find the intervention acceptable and helpful? 3. What benefits do children show in mobility, participation, and engagement after using powered mobility? In this study, therapists and families will: 1. Take part in a training program about how to use powered mobility with young children 2. Use powered mobility devices (Permobil Explorer Mini) with children during everyday routines 3. Complete surveys, interviews, and observations about their experiences

A Center Based Early Intervention Program For Preschoolers With Developmental Disorders

The purpose of this study is to examine the effectiveness of a 12-week early intervention program that will include 12 weekly hours in an intensive center-based preschool environment or in the home to treat social communication deficits in children with developmental disorders. The study will include children with developmental disorders, such as Autism Spectrum Disorder, neurogenetic disorders, or intellectual disability.

Diné Parents Taking Action Trial

The goal of this clinical trial is to learn if a family support program helps Navajo parents and guardians of children with autism spectrum disorder (ASD) or other developmental concerns. The main questions it aims to answer are: * Is the program something families find useful and easy to take part in? * Does the program raise parents' knowledge and confidence in using strategies that support their child's development? * Does the program help children improve in areas such as social communication? Researchers will compare two groups: * One group of parents will join the program right away. * The other group will join the program after waiting. Participants will: * Be randomly placed into the "immediate" or "waitlist control" group using simple randomization. * Take part in sessions led by trained Navajo Family Advisors, who are parents of children with ASD. * Learn and practice strategies they can use at home to support their child * Answer surveys about their experience, knowledge, and their child's progress

Interventions in Mathematics and Cognitive Skills

The purpose of this study is to investigate neurocognitive mechanisms underlying response to intervention aimed at enhancing, and remediating weaknesses in, numerical skills in children, including those with mathematical learning disabilities (MLD).

Developing and Examine the Efficacy of the Family-Centered Multi-Sensory Environment Intervention on Parent's Empowerment and Children's Engagement (MSE-PEACE) in Children With Developmental Disabilities and Their Parents: A Mixed Methods Study

The goal of this clinical trial is to learn whether a family-centered multi-sensory environment (MSE-PEACE) can help children with developmental disabilities and support their parents. The main questions it aims to answer are: Can the MSE-PEACE program improve children's participation and emotional self-regulation? Does it help parents feel more confident and empowered in their caregiving role? Participants will include children ages 3 to 12 years and their parents. All children have been diagnosed with a developmental disability such as autism, ADHD, or cerebral palsy. Participants will: Join 10 multi-sensory sessions, held every 2 weeks, each lasting about 60 minutes Complete questionnaires and interviews before and after the sessions Receive support and suggestions for using sensory-based activities at home This study will collect both survey and interview data to understand how the program affects children's daily functioning and how it supports parents' confidence and well-being.

PGx Medication Safety Reviews of Persons With IDD

The purpose of this study is to assess the feasibility of a comprehensive medication review and PGx initiative as part of the care process for individuals in the care of CP Unlimited. This initiative may help improve management of medications and overall health and well-being for participating individuals. Please note that in the context of the research being conducted, all information will remain confidential and deidentified for analyses. Under the proposed study protocol, CP Unlimited, in partnership with pharmacists at GalenusRx, will implement and assess a comprehensive medication safety and PGx initiative. Almost three quarters of all clinical trials have eligibility criteria resulting in the exclusion of adults with IDD. This study will help address ongoing health practice disparity. As indicated above, the investigators are requesting the authorization of the guardian or representative, on behalf of the participant under their supervision, to enroll this individual in the proposed study because she/he is currently prescribed medications or may eventually receive prescribed or over-the-counter medications. Hereinafter, the denomination "he/she, him/her, his/her or them/their" will be used to refer to the individual with IDD. The response to medication can be affected by variations in our genes and by other medications and various disease conditions. Information contained in our genes can vary from one patient to another patient and this can explain why we all can respond differently to medications. Genetic testing and a review of his/her medications can help to determine if the medication will work for him/her. PGx is how his/her genes affect the way he/she responds to specific drugs. PGx can tell if he/she is more or less likely to feel bad reactions to a drug, or if a drug is likely to benefit him/her and be safe for him/her to take. Knowing his/her genetic information and all medicines that he/she is taking can help his/her pharmacist and his/her doctor find the combination of medicines that will work the best for him/her, now and in the future.

Using a Smart Inhaler to Support Asthma Management in Adolescents With Intellectual and Developmental Disabilities

Correct use of daily medications containing inhaled corticosteroids is key for asthma control, yet children with intellectual and developmental disabilities (IDD) face additional barriers to proper inhaler use. Smart inhalers, a novel technology that provides guidance and immediate feedback on inhaler use techniques, have been shown to enhance correct medication administration in the typically developing pediatric population, but their effectiveness has not been evaluated on the pediatric IDD population. This study aims to investigate whether daily application of smart inhalers (1) is feasible and acceptable in the IDD population, (2) improves the rate of correct medication administration, and (3) results in improvement in lung function. This effort aims to promote better asthma management in the IDD population.

Association Between Motor Skills and Sensory Profiles in Children With Typical and Atypical Development Aged 4 to 11 Years

Background and Justification Childhood developmental disorders, such as Autism Spectrum Disorder (ASD), Attention Deficit Hyperactivity Disorder (ADHD), and Developmental Coordination Disorder (DCD), pose significant challenges for children and their families. These disorders impact children's growth and learning, leading to difficulties in key areas such as language, communication, behavior, social interaction, and motor skills. Research in this area is limited, particularly regarding fine and gross motor skills in relation to sensory processing in children with these diagnoses. Hypothesis and Objectives There is an association between motor skills and sensory processing in children aged 4 to 11 years, depending on whether they have typical or atypical neurodevelopment, such as ASD, ADHD, and DCD. Main Objective: To evaluate the association between motor skills and sensory processing in children aged 4 to 11 years with either typical or atypical neurodevelopment (e.g., ASD, ADHD, and DCD). Secondary Objectives: To describe and compare motor skills among children aged 4 to 11 years with typical or atypical neurodevelopment, such as ASD, ADHD, and DCD. To describe and compare sensory processing among children aged 4 to 11 years with typical or atypical neurodevelopment, such as ASD, ADHD, and DCD. Methodology The study is a cross-sectional observational case-control study. Participants are users of the Child Development and Early Intervention Center (CDIAP) Tris Tras, Neuro Xics, or Criv in Vic. The sample will include 30 children as controls (typical neurodevelopment) and 10 children as cases (atypical neurodevelopment: ASD, ADHD, DCD). Children will be assessed using the Infant Motor Profile (IMP) to measure motor development and the Short Sensory Profile-2 (SSP-2) to evaluate sensory processing. Statistical Analysis Quantitative variables will be described using means and standard deviations, while categorical variables will be presented as frequencies and percentages. Statistical tests such as the Student's t-test will be used to compare means between two groups, ANOVA for comparisons among more than two groups, and the Chi-square test to analyze associations between categorical variables. Expected Results The study is expected to provide essential insights into the differences in motor development between children with typical and atypical neurodevelopment, as well as the relationship between biological and external factors and these differences. These findings could help improve clinical and educational interventions for these children by tailoring them to their specific needs, thereby enhancing their overall well-being and development. Ethical Considerations The study protocol will be submitted to the Research Ethics Committee (CER) of UVic-UCC, adhering to good clinical practice guidelines in accordance with the Declaration of Helsinki. Participants will be assigned a code to ensure data pseudonymization, with data securely stored on the Microsoft 365 server of UVic-UCC. Participants will have the right to withdraw from the study at any time, and personal data will be deleted once the study is completed. Researchers will ensure confidentiality as dictated by Organic Law 3/2018 of December 5 on the Protection of Personal Data and Guarantee of Digital Rights, Regulation (EU) 2016/679 of April 27, 2016, on data protection, and complementary regulations, as well as Organic Law 1/1982 of May 5 on the right to honor, personal and family privacy, and self-image.

PRT for Adolescents With High Functioning Autism

The purpose of this study is to identify improvement in behavioral and social function and changes in the brain following Pivotal Response Treatment (PRT) for Adolescents in highly verbal adolescents with autism spectrum disorder (ASD).

Neuropsychological and Brain Medical Imaging Study in Patients With Brain Damage 2

Two groups of subjects will be constitute: (i) patients with circumscribed brain injury (including stroke, vascular malformations, tumor or circumscribed infectious lesions) or degenerative/developmental disorders and selective cognitive disorders; (ii) healthy control subjects. The objective of this project is to evaluate specific neuropsychological deficits and apply current brain imaging techniques (anatomical, diffusion, functional, magnetic stimulation) to patients suffering from these cognitive deficits due to brain damage, in order to elucidate the brain mechanisms underlying these deficits.

Evaluation of Telehealth Services on Mental Health Outcomes for People With Intellectual and Developmental Disabilities

Roughly 40% of those with intellectual and developmental disabilities (IDD) have mental health needs, which is twice the national average. Nevertheless, there is dearth of evidenced-based mental health treatment for youth and young adults with IDD. The disparity in access to mental health care places those with IDD at greater risk of crisis service use. While telemental health studies demonstrate potential to enhance access to care, little of this research includes those with IDD, or crisis prevention and intervention. This project will refine and evaluate telemental health services for youth and young adults with IDD delivered within START (Systemic, Therapeutic, Assessment, Resources, and Treatment), a national, evidence-based model of crisis prevention and intervention for people with IDD. The study will begin with stakeholder feedback (service recipients, families, and providers) regarding telemental health services (Aim 1). Results will be used to refine the intervention. Our team will then compare telemental health versus in-person START services in a randomized control trial (Aim 2). To our knowledge, this will be the first trial of a telemental health crisis program for the IDD population. The final goal is to understand if outcomes vary across subpopulations (Aim 3) and to identify potential disparities. If found, the investigators will work with service users, families and providers to develop a strategy to address identified disparities in outcomes. The study will be executed by an interdisciplinary team of experts engaged with stakeholder partners. Understanding the benefits of specific telemental health methods has important implications to the design of interventions, within and outside of START. This telemental health study offers promise to address disparities in access to mental health care for people with IDD.