The state of North Carolina currently has 10 active clinical trials seeking participants for Autism research studies. These trials are conducted in various cities, including Durham, Charlotte, Winston-Salem and Chapel Hill.
The Autism Biomarkers Consortium for Clinical Trials: Confirmation Study
Recruiting
This is a multicenter longitudinal study that aims to validate a set of measures that were previously identified as promising candidate biomarkers and/or sensitive and reliable objective measures of social function in ASD for potential use in clinical trials. The confirmation study will repeat the data collection and analysis protocols from the original ABC-CT study. This confirmation study will recruit 200 ASD and 200 TD comparison participants who are 6-11 years old, matching the overall sampl... Read More
Gender:
ALL
Ages:
Between 6 years and 11 years
Trial Updated:
02/18/2025
Locations: Duke, Durham, North Carolina
Conditions: Autism Spectrum Disorder
Multicenter Study of Lumateperone for the Treatment of Irritability Associated With Autism Spectrum Disorder (ASD) in Pediatric Patients
Recruiting
This is a multicenter, randomized, double-blind, placebo-controlled study in pediatric patients aged 5 to 17 years with a primary diagnosis of irritability associated with Autism Spectrum Disorder (ASD) based on Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Text Revision (DSM-5-TR) and confirmed by the Kiddie Schedule for Affective Disorders and Schizophrenia Present and Lifetime Version (K-SADS-PL).
Gender:
ALL
Ages:
Between 5 years and 17 years
Trial Updated:
01/24/2025
Locations: Clinical Site, Kinston, North Carolina
Conditions: Irritability Associated With Autism Spectrum Disorder
Physical Activity and Community EmPOWERment Project
Recruiting
Purpose: Conduct a wait-list randomized controlled trial (RCT) of an inclusive physical activity program called PACE for adults with intellectual disability (ID) who are not yet showing signs of Alzheimer's Disease (AD)/age-related dementias (ARD). Participants: Participants include 120 adults with ID, their caregivers, and their coaches (up to 360 individual participants, grouped as triads), recruited through the University of North Carolina at Chapel Hill and the University of Arkansas. Parti... Read More
Gender:
ALL
Ages:
18 years and above
Trial Updated:
01/14/2025
Locations: University of North Carolina, Chapel Hill, North Carolina
Conditions: Intellectual Disability, Neurodevelopmental Disorders, Autism Spectrum Disorder, Down Syndrome, Fragile X Syndrome, Cri-du-Chat Syndrome, De Lange Syndrome, Mental Retardation, X-Linked, Prader-Willi Syndrome, Rubinstein-Taybi Syndrome, Trisomy 13 Syndrome, WAGR Syndrome, Williams Syndrome
A Comparison of Two Brief Suicide Prevention Interventions Tailored for Youth on the Autism Spectrum
Recruiting
Rates of suicide have increased significantly over the past two decades, particularly among youth. Compared to the general population, autistic people are significantly more likely to think about suicide, attempt suicide, and die by suicide. Autistic individuals have identified suicide prevention as a top research priority; however, little is known about how to best help autistic youth at risk for suicide. The purpose of this study is to compare the effectiveness, feasibility, and acceptability... Read More
Gender:
ALL
Ages:
Between 12 years and 99 years
Trial Updated:
01/13/2025
Locations: University of North Carolina at Chapel Hill, Chapel Hill, North Carolina
Conditions: Suicidal Ideation, Suicidal and Self-injurious Behavior, Suicide, Autism Spectrum Disorder
Expediting Access to Services for Equity (EASE)
Recruiting
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 aut... Read More
Gender:
ALL
Ages:
Between 1 year and 99 years
Trial Updated:
01/07/2025
Locations: Carolina Institute for Developmental Disabilities, Carrboro, North Carolina
Conditions: Autism Spectrum Disorder
STRW-T Intervention for Autistic Adolescents in 11th and 12th Grade
Recruiting
The current study seeks to compare outcomes of a telehealth intervention targeting daily living skills (Surviving and Thriving in the Real World - Telehealth, or STRW-T) intervention to a control group telehealth intervention targeting social skills (Program for the Education and Enrichment of Relational Skills- Telehealth, or PEERS-T). The key endpoint will be change in daily living skills on primary and secondary outcome measures at the end of treatment.
Gender:
ALL
Ages:
Between 15 years and 21 years
Trial Updated:
11/22/2024
Locations: University of North Carolina - Chapel Hill, Carrboro, North Carolina
Conditions: Autism Spectrum Disorder
ABC-CT Pre-School Feasibility Study
Recruiting
This is a multicenter study that aims to determine whether the EEG and ET experiments studied in the ABC-CT Phase 1 and ABC-CT Confirmation studies can be successfully used with 3-5-year-old children and to determine the viability of these measures as potential biomarkers in 3-5-year-old children with ASD. Blood (DNA) samples will be collected from participants with ASD and biological parents for future genomic analyses, and raw, processed, and analyzed data will be shared to create a community... Read More
Gender:
ALL
Ages:
Between 3 years and 5 years
Trial Updated:
10/01/2024
Locations: Duke University, Durham, North Carolina
Conditions: Autism Spectrum Disorder
Comparing Cognitive-Behavioral Therapy Versus Mindfulness-Based Therapy for Autistic Adults
Recruiting
Autistic adults are at a greater risk for mental health problems compared to the general population, with 50% meeting criteria for a co-occurring psychiatric condition. Depression and anxiety are the most common of these conditions among autistic adults, contributing to long-term detrimental effects on health, day-to-day functioning, and quality of life. This study will conduct the first large-scale head-to-head comparison of the two most widely studied mental health interventions for autistic a... Read More
Gender:
ALL
Ages:
18 years and above
Trial Updated:
06/26/2024
Locations: University of North Carolina at Chapel Hill, Chapel Hill, North Carolina
Conditions: Autism Spectrum Disorder, Depression, Anxiety
SenseToKnow Autism Screening Device Validation Study
Recruiting
This is a pivotal, prospective, double-blind, study to evaluate the sensitivity and specificity of the SenseToKnow app for the detection of autism spectrum disorder in children 16-36 months of age.
Gender:
ALL
Ages:
Between 16 months and 36 months
Trial Updated:
05/21/2024
Locations: Duke University, Durham, North Carolina
Conditions: Autism, Autism Spectrum Disorder
Peer Interventions for Preschoolers With Autism
Recruiting
This proposal will evaluate a series of peer-mediated interventions (PMIs) for preschool children (3 to 6 years) with ASD and limited or no spoken language, using an innovative Sequential Multiple Assignment Randomized Trial (SMART) design. Available evidence supports the beneficial effects of PMIs for improving social communication in children with ASD. Peer-related social competence is vital to a wide range of child outcomes, such as improved communication and fewer behavioral problems. Unfort... Read More
Gender:
ALL
Ages:
Between 3 years and 6 years
Trial Updated:
03/26/2024
Locations: University of North Carolina, Chapel Hill, North Carolina
Conditions: Autism Spectrum Disorder