Clinical Research Directory

Evaluation of Effectiveness of Child-oriented Goal-setting in Paediatric Rehabilitation (the ENGAGE Approach)

Children with disabilities often access rehabilitation services to improve their abilities to participate in everyday activities. Goal-directed therapy is considered an important therapeutic strategy to achieve outcomes that are meaningful to families. Not a lot is known about the effects of goal setting on rehabilitation outcomes. Strategies to help children participate in the goal-setting process are rarely used in clinical practice. The aim of this project is to test the effects of a child-focussed goal setting approach, Enhancing Child Engagement in Goal Setting (ENGAGE), on therapy outcomes. Service use and the cost vs. benefits of the ENGAGE approach compared to usual practice will also be examined. Children with neurodevelopmental disabilities aged 5-12 years old (n=96) who access paediatric rehabilitation services at six rehabilitation sites will participate. Therapists (n=24) at participating sites in Alberta, Canada will be randomized into 1) the ENGAGE intervention group or 2) the usual therapy practice control group. Children will participate in the ENGAGE approach to goal setting or usual practice based on the allocation of their therapist. This study will determine if the ENGAGE approach to goal setting affects child goal performance, satisfaction with goal performance, functional abilities, participation, and parent and child quality of life. The investigators will also evaluate differences in parent and child quality of life in relation to parent costs (e.g., absenteeism, presenteeism, travel costs) and compare amount of therapy time between the two groups to see which approach is more cost-effective and efficient. After the study, children, parents and therapists will be asked to discuss aspects that influenced effective implementation of the ENGAGE approach. This study could provide evidence to improve meaningful child and family outcomes in paediatric rehabilitation and improve efficiency of paediatric rehabilitation services.

Aerobic Exercise for Sleep in Children With ASD

Autism Spectrum Disorder (ASD) is a neurodevelopmental condition characterized by impairments in social interaction and communication. Children with ASD frequently experience co-occurring behavioral problems, among which sleep disturbances are highly prevalent, affecting approximately 40%-80% of children and adolescents with ASD. These sleep problems pose a substantial burden during childhood and adolescence. This study employs a two-phase design to examine the effects of an acute aerobic exercise intervention combined with a parent-mediated cognitive behavioral program on sleep problems in children with autism spectrum disorder (ASD). Phase 1 consists of cross-sectional assessments comparing sleep efficiency, physical fitness, and attentional performance among children with ASD with and without sleep problems and typically developing children. Phase 2 is a randomized controlled intervention trial involving children with ASD and comorbid sleep problems, in which participants are assigned to either an aerobic exercise plus cognitive behavioral intervention group or a control group receiving cognitive behavioral strategy materials only. The intervention lasts two weeks. Outcomes related to autistic symptoms, sleep efficiency, physical activity level, attentional performance , and adaptive behaviors are assessed before and after the intervention to evaluate intervention effects.

Expediting Access to Services for Equity

The goal of this clinical trial is to assess whether telehealth-based Family Navigation (FN) expedites enrollment (e.g., reduces time in days) in community-based autism intervention for Black toddlers under the age of 4 after their initial diagnosis of autism. The main questions it aims to answer are: Does Family Navigation decrease the time to initiation of intervention for Black toddlers with autism? Does Family Navigation improve developmental outcomes at 18 months post-diagnosis of autism? Does Family Navigation improve caregiver well-being? Caregivers in the Family Navigation condition will receive 4 research-based individual sessions with a trained navigator to support them in identifying and enrolling in recommended autism early intervention services. All navigation sessions will be delivered virtually via phone/Zoom. Researchers will compare participants who receive family navigation to participants who receive the standard of care (educational materials) to see if family navigation outperforms the standard of care.

Effectiveness of Caregiver-involved Group-based NDBIs Intervention for Autistic Preschoolers

This is a study that investigate the feasibility, acceptability, and preliminary efficacy of NDBIs for autistic preschoolers delivered in a group-setting. The outcome measures assess the improvements in autistic symptoms, social communication, play skills, group behaviors, adaptation, and parent stress.

Behavior Analytic Support of Needle-related Hospital Visits for Autistic Patients

The purpose of this study is to evaluate the effectiveness of the behavior analytic intervention in reducing the number of challenging behaviors exhibited by patients with Autism Spectrum Disorder (ASD) while increasing compliance with needle-related simulations and procedures. A second purpose is to assess the social validity of this study as evidenced by patient and/or caregiver acceptability. The study wil take place at Boston Medical Center (BMC). A Single Subject Design (SSD) wil be utilized as it allows for detailed, individualized assessment of how interventions affect behavior over time in this type of behavior analytic research. By focusing on each participant as an individual and having each participant act as their own control, it demonstrates clear cause-and-effect relationships, showing how behavior changes with the introduction or withdrawal of an intervention. This method is flexible, enabling ongoing adjustments to treatments based on real-time data, making it particularly useful in personalized interventions and ensuring effectiveness for patients with unique needs such as those who would be eligible to enroll and participate in this study.

Exploring the Gut-Brain-Behavior Axis With Biomarkers, Probiotic Efficacy, and Artificial Intelligence Algorithms

With an increased prevalence of autism spectrum disorder (ASD) worldwide and in Taiwan, ASD demands urgent attention due to its lasting impact, unclear causes, and limited diagnostic and treatment options. Recent studies highlight disruptions in the gut-brain axis, particularly in ASD. Building on PI Gau's prior research on altered gut microbiota in autism spectrum disorder (ASD), this proposed 4-year study aims to develop evidence-based probiotic intervention (GKB7) and treatment biomarkers for behavioral interventions (Naturalistic Developmental Behavioral Interventions, NDBI, and Program for the Education and Enrichment of Relational Skills, PEERS®) through comprehensive assessments. The ultimate goal is to establish probiotic treatments and diagnostic/treatment biomarkers for ASD utilizing a deep-learning multimodal auxiliary platform. Specific Aims: S.I To conduct a randomized, double-blind, placebo-controlled trial to assess the treatment effects of Clostridium butyricum GKB7 on ASD. S.II To investigate the effect of NDBI intervention trials using metagenomics as the outcome measure. S.III To evaluate the effect of PEERS® interventional trials with metagenomics as the outcome measure. S.IV To develop an artificial intelligence (machine/deep learning) multimodal auxiliary prediction platform that integrates environmental, behavioral/clinical, neurocognitive/imaging, and metagenomic data for ASD diagnosis, subtyping, and impairment prediction. S.V To identify microbiome and metabolomic biomarkers and endophenotypes of ASD, and to establish Gut-Brain-Behavioral Axes in ASD.

Trial of Autism Parent Navigator Program

To address the dual needs of parents for support in navigating Autistic Spectrum Disorder (ASD) services and maintaining positive family functioning, the investigators propose to test Autism Parent Navigators (APN), an innovative in-home, peer support model for parents with a young child recently diagnosed with ASD.

Evaluating Additive Effects of Including Canines in Regulating Together

The primary objective is to evaluate the potential additive effect of animal-assisted intervention (AAI) on a manualized behavioral treatment targeting emotion dysregulation (ED) in children with autism spectrum disorder (ASD). Aim 1: Evaluate whether Regulating Together-Canine demonstrates earlier and greater improvement in emotion dysregulation than Regulating Together-Standard. Aim 2: Evaluate if Regulating Together-Canine increases child engagement and learning compared to Regulating Together-Standard. Exploratory Aim: Explore association of physiological arousal (via heart rate tracking) with emotion dysregulation, treatment engagement, and learning.

AI-Based Reflective Parenting Simulation for Parents of Autistic Children

This randomized controlled trial evaluates an AI-based parental simulation designed to support reflective parenting, emotional regulation, and parent-child communication among parents of autistic children aged 3 to 12 years. A total of 140 parents will be recruited through an external online survey platform and randomly assigned to an intervention group or a control group. The intervention group will complete baseline questionnaires, engage with the AI-based simulation, and then complete post-intervention measures. The control group will complete baseline and post-assessment measures before receiving access to the simulation.

Refining and Implementing Technology-Enhanced Family Navigation to Promote Early Access and Engagement With Mental Health Services for Youth With Autism

This project, Refining and Implementing Technology-Enhanced Family Navigation to Promote Early Access and Engagement with Mental Health Services for Youth with Autism (ATTAIN NAV) is focused on adapting and implementing family navigation in primary care settings to help accelerate and facilitate engagement in mental health and community services for children with autism and their families.

Transcranial Photobiomodulation for Reducing Autism Symptoms in Children

The hypothesis of the study is that photobiomodulation reduces symptoms of autism. Participants will be children between the ages of 2 and 6, who have been diagnosed with moderate to severe autism. Transcranial photobiomodulation will be administered to the children in the experimental condition twice a week for 8 weeks. Results will be measured through parental interviews, standardized CARS2 (Childhood Autism Rating Scales, 2nd Edition) and data collected from EEG.

Improving the Part C Early Intervention Service Delivery System for Children With ASD

Despite strong consensus that early, specialized intervention for children with autism spectrum disorder (ASD) can have a dramatic impact on outcomes, the public health system's capacity to provide such services is severely challenged by the rapid rise in ASD prevalence. The goal of this research project is to increase timely and equitable access to ASD-specialized early intervention during the critical first three years of life by capitalizing on the existing infrastructure of the Part C Early Intervention (EI) system, which is publicly funded and available in all states in the United States. This project will train EI providers to use an evidence-based, parent-mediated intervention that can improve child and family outcomes as well as mitigate the long-term substantial economic costs associated with ASD.

Safety and Tolerability Trial of Lumateperone in Pediatric Patients With Schizophrenia, Bipolar Disorder or Autism Spectrum Disorder

This is a multicenter, global, 26-week, open-label study to assess the safety and tolerability of lumateperone in pediatric patients with schizophrenia, bipolar disorder or autism spectrum disorder.

The (Cost)Effectiveness of a Social Robot for Persons With Problems in Daily Structure and Planning in Disability Care

The goal of this multiple baseline single case study is to study the (cost)effectiveness of a social robot in reducing professional caregiver support and promoting independence for individuals in long-term disability care experiencing problems with daily structure and planning. The main research questions it aims to answer are: * What is the effect of the social robot on the frequency of moments professional caregivers support individuals experiencing problems with daily structure and planning with the execution of daily activities, compared to care as usual, after 6 weeks? * Does the effect of the social robot persist in the long term (after 6 months)? * What is the cost-effectiveness of the social robot? Participants will: * Use a social robot in their daily living environment * Answer survey questions about their quality of life and wellbeing during the study period * Share their experiences in interviews Their profesional caregivers will: * Register the frequency and duration of support they provide to the participant daily for 13 weeks and a 2-week follow-up * Give weekly updates and score participants' goal attainment while using the social robot * Fill in questionnaires on participants' productivity and health care consumption during the study period * Share their experiences in interviews

Culturally Adapted Intervention to Prevent Self-harm in Young People With Autism

The goal of this feasibility randomized controlled trial is to assess the feasibility and acceptability of Youth Culturally Adapted Manually Assisted brief psychological intervention (YCMAP) in young people with autism in Pakistan. In a rater-blind, 2-arm, multi-site, feasibility randomized controlled trial (RCT), participants will be randomized either to 1) YCMAP added to the Treatment as Usual (TAU) or 2) TAU alone. Participants in the Y-CMAP arm will receive 8-10 sessions delivered individually over 3 months (weekly for 1 month then fortnightly), lasting for 60 minutes. Assessments will be conducted at baseline and at 3 months.

Internet-delivered Cognitive-Behavioral Therapy for Adolescents With Autism and Anxiety

Anxiety is very common in autistic youth. Cognitive behavioral therapy (CBT) is the recommended treatment for both autistic and typically-developing (TD) youth with anxiety, yet most families cannot access CBT due to cost, practicalities of attending in-person treatment sessions, and a shortage of trained providers, especially in rural areas. The goal of this project is to increase access to care for families of autistic adolescents with anxiety through an internet-based treatment model.

Nature and Animal-assisted Activities

Neuropsychiatric impairments in young adults are common and can involve social withdrawal, and difficulties in receiving support from healthcare and municipal social care services. Collaboration is needed, but knowledge gaps exist concerning effective interventions. Participation in meaningful activities, as a complement to other treatment strategies can be a step towards studies/work. The aim of the trial is to explore the feasibility of a structured nature and animal-based activity on a farm for young adults with neuropsychiatric impairments. The intervention involves participation in nature and animal-assisted group activities, twice a week for 12 weeks. Data consists of interviews with participants prior to and after the intervention, as well as one year later. The one-year follow-up focus is on life situation, changes in everyday life and experiences of the intervention. In addition, interview-based experiences of the ordinary staff and supervisors on the farm are included. Analysis will be carried out with qualitative content analysis, as well as health-economic calculations.

DBT Skill Training for Autistic Adults With Difficulties in Emotion Regulation.

One in 44 has autism, 70% of them have additional mental health challenges. Currently, this patient population does not have access to effective treatment within specialist healthcare services and has struggled to benefit from standard treatments. The goal of this project is to increase access to treatment tailored to their challenges. We will investigate whether a treatment program with an adapted version of Dialectical Behavior Therapy (DBT) is feasible, accepted, and perceived as useful for people with autism. The purpose of the treatment is to improve emotion regulation, function better in relationships, and avoid crises, thereby enhancing their ability to achieve personal goals, reduce suffering, and increase quality of life. Autism is a lifelong neurodevelopmental disorder, presenting with great variation and more widespread than previously thought. Difficulties with emotion regulation are a central challenge for many with autism. These difficulties often manifest as an inability to recognize, understand, and manage emotional responses, leading to destructive strategies, behaviors, and suffering. DBT is developed with a focus on emotion regulation and has shown good effects in other patient populations. The project can increase access to treatment for a patient population that currently stands without.

Autism and Attachment. An Explorative Study of Attachment Styles in Autistic Adults.

The present study examines the relationship between attachment and autism spectrum disorder (ASD) in adults.

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.

STEPS: A Virtual Reality-based Intervention for Adults With Autism.

The goal of this clinical trial is to learn if a new Virtual Reality-based intervention will be effective in treating social cognitive challenges in adults with autism. The main questions it aims to answer are: 1. Is Virtual Reality-based social cognitive training effective in reducing social cognitive deficits and improving psychosocial functioning, quality of life, and clinical symptoms in adults with ASD? 2. Is Virtual Reality-based social cognitive training cost-effective? Researchers will compare Virtual Reality-based pro-functional, Social Cognitive Training (VRSCT) to treatment as usual (TAU) to evaluate effectiveness. Participants will be allocated to receive either VRSCT once a week in addition to treatment as usual (TAU) or TAU alone for 3 months. All participants will undergo a thorough assessment at baseline, and at 3 and 6 months post-baseline.

Developing Brain, Impulsivity and Compulsivity

Background: Impulsivity is acting 'without thinking.' Compulsivity is being overly inflexible. People vary in how impulsive or compulsive they are. Extreme versions of these behaviors play a role in mental disorders. Researchers want to study changes in the brain to learn more about these behaviors. Differences in genes may also play a role. Objective: To learn about genetic \& brain features that explain why levels of impulsivity and compulsivity vary across people. Eligibility: People ages 6 - 80 Design: Participants will be screened with a medical history and medical record review. Participants will talk about their mental and behavioral development. They may discuss topics like drug use and sexual activity. They will complete surveys about their compulsivity and impulsivity. Parents of child participants may also complete these surveys. Participants may take memory, attention, and thinking tests. They may give blood or saliva samples for gene studies and they may give blood to make induced pluripotent stem cells. Participants may have their face and irises photographs taken. Participants may have a magnetic resonance imaging scan. It will take pictures of their brain. The scanner is shaped like a cylinder. Participants will lie on a table that slides in and out of the scanner. A coil will be placed over their head. They will lie still, watch a movie, and play a game. Participants may ask family members to join the study. Researchers are particularly interested in recruiting twin pairs to the study. Participants under age 25 may repeat these tests every 1-2 years until they turn 25 or until the study ends. For those over age 25, participation will last less than 1 month.

A Center Based Study of Pivotal Response Treatment for Preschoolers With Autism

The purpose of this study is to examine the effectiveness of pivotal response training (PRT) in an intensive center-based environment to treat social communication deficits in children with autism spectrum disorder (ASD).

A Study of Esomeprazole in Children With Autism

Autism is a pervasive developmental disorder characterized by core deficits in social behavior and communication and the presence of repetitive/stereotyped behaviors. The objective of the study is to evaluate the efficacy of Esomeprazole as a treatment for social communication deficits in children with Autism Spectrum Disorder (ASD). This prospective 12 week open-label study will invite 25 children with ASD between the ages of 2 and 6 years of age to participate.