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utism spectrum disorder is an umbrella term for a wide range of conditions primarily characterized by difficulties with communication, and marked behaviors such as repetition (of words or behaviors); social withdrawal lack of interest in relationships; and in some cases speech impairments.

The Centers for Disease Control and Prevention estimate that 1 in 59 children fit in the criteria for autism spectrum disorder, and it is four times more common in boys than in girls. There are no known causes for autism, however research has suggested that genetic factors seem to play a role in the development of the condition.

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What is a Clinical Trial?

Clinical trials are designed to test interventions such as new medical devices, lifestyle changes, or medications. After many years of empirical and laboratory research, scientists and doctors design a clinical trial in order to determine if their intervention is safe and effective for their target population.

Clinical trials are separated into the following phases:

Phase 0

At this point, scientists are interested in learning how the medication works, and to do so they recruit a very small number of volunteers. Usually, a group between 10 and 15 individuals will test the medication to determine if the drug is safe in humans.

Phase I

The aim of phase I is to determine how the drug works in the body for an extended period of time. Phase I is usually conducted in healthy individuals and the group tends to be larger than in phase 0.

Phase II

After the medication was deemed safe in phase I, it is ready to be tested in the target population. This means that if the new intervention is aimed towards individuals with autism, in phase II researchers will look for individuals with autism.

Phase III

During this phase researchers need to recruit a large number of individuals (3,000 or more) and will compare the intervention tp already-existing standards that are used for treating the target condition. For example, if researchers are developing a new headache medication they will need to compare it to what has already been demonstrated to work for headaches (i.e. ibuprofen) to determine if the new treatment at least as effective, safe, and accessible as the current standard.

Phase IV

This phase is usually ongoing and occurs after the drug has been approved and it is available to the general population. Many years after a treatment has been released, researchers have to continue gathering information about the safety and effectiveness of the intervention.

What Are My Rights/My Loved Ones Rights As a Clinical Trial Participant?

Clinical trials are completely voluntary, that means that even if your doctor offered you or advised you or your family member to enroll in a clinical trial the decision is always yours.

All study participants/legal guardians have the right to decide whether they want to participate or not in a clinical trial. Even if you agreed to participate at first you have the right to withdraw your consent at any point during the study.

Typically, the information that researchers gather from a clinical trial is completely confidential, and you have the right to keep it that way. Before you or your loved one enrolls in a clinical trial, the research staff will ask you to fill out an informed consent form that will explain how they plan to keep your information safe and confidential.

Match to Autism Clinical Trials

  • Access to cutting-edge treatments
  • Latest clinical trials
  • Find trials in your area

Why Is Autism Research Important?

Currently, there are no drugs or interventions available that effectively treat or cure autism spectrum disorder. However, researchers are working tirelessly to find an intervention that can help individuals with autism and their loved ones cope better.

Clinical trials are a critical part of that process. Without clinical trials researchers would not be able to test new interventions and determine what works what doesn’t on people with autism.

Many times the outcome of a clinical trial is that the intervention was not effective, however, this does not mean that your participation was in vain. Even if you didn’t receive a direct benefit, when you or your loved one decides to participate in a clinical trial, you are helping scientist develop better and more effective treatment and interventions that can significantly improve the quality of life of future generations.

ClinicalTrials.gov: Recruiting Studies | Autism | Last update posted in the last 300 days Studies found on ClinicalTrials.gov by a search of: Recruiting Studies | Autism | Last update posted in the last 300 days

  • Genotype-phenotype Correlations in Children and Adults With CTNNB1 Mutation
    on March 23, 2021 at 4:00 pm

    Condition:   CTNNB1 Gene MutationInterventions:   Diagnostic Test: The Modified Checklist for Autism in Toddlers, Revised with Follow-Up (M-CHAT-R/F);   Diagnostic Test: The Autism Spectrum Quotient-Children's Version (AQ-Child);   Diagnostic Test: The Autism-Spectrum Quotient (AQ)-Adolescent Version (AQ-Adolescent);   Diagnostic Test: The Viking's Speech Scale;   Diagnostic Test: The Functional Communication Classification System (FCCS);   Diagnostic Test: Brief Infant Sleeping Questionnaire (BISQ);   Diagnostic Test: Pediatric Sleep Questionnaire (PSQ);   Diagnostic Test: The Eating and Drinking Ability Classification System (EDACS);   Diagnostic Test: Mini Manual Ability Classification System (Mini-MACS);   Diagnostic Test: Manual Ability Classification System (MACS);   Diagnostic Test: The Gross Motor Function Classification System - Expanded and Revised (GMFCS - E&R);   Diagnostic Test: The Visual Function Classification System (VFCS);   Diagnostic Test: The Early Childhood Oral Health Impact Scale (ECOHIS);   Diagnostic Test: The Family Impact Scale (FIS);   Diagnostic Test: The Achenbach System of Empirically Based Assessment (ASEBA);   Diagnostic Test: Adaptive Behavior Assessment System Third Edition (ABAS-3)Sponsors:   University Medical Centre Ljubljana;   University of Ljubljana, Faculty of Medicine;   National Institute of Chemistry, Ljubljana, SloveniaRecruiting

  • Services to Enhance Social Functioning in Adults With Autism Spectrum Disorders
    on March 9, 2021 at 5:00 pm

    Conditions:   Autism;   Autism Spectrum Disorder;   Autistic Disorder;   Asperger Syndrome;   Pervasive Developmental DisorderIntervention:   Behavioral: Training to Understand and Navigate Emotions and Interactions (TUNE In)Sponsor:   University of PennsylvaniaRecruiting

  • Transdiagnostic Group Behavioral Activation for Autistic Adults
    on March 9, 2021 at 5:00 pm

    Conditions:   Autism Spectrum Disorder;   Depression, Anxiety;   Anxiety;   AngerIntervention:   Behavioral: Group Behavioral Activation Therapy for Autism Spectrum DisorderSponsor:   Rutgers, The State University of New JerseyRecruiting

  • Effectiveness of a 6-week Hippotherapy Program in Children With Autism Spectrum Disorder
    on February 26, 2021 at 5:00 pm

    Condition:   Autism Spectrum DisorderIntervention:   Behavioral: HippotherapySponsor:   Creighton UniversityRecruiting

  • Examining the Effects of a Job Entry Intervention
    on February 25, 2021 at 5:00 pm

    Conditions:   Autism Spectrum Disorder;   Autism;   ASDIntervention:   Behavioral: VR-JIT/KF-STRIDESponsor:   Kessler FoundationRecruiting

  • Motor Impairments in Children With Autism Spectrum Disorder: a Multimodal Approach
    on February 24, 2021 at 5:00 pm

    Conditions:   Autism Spectrum Disorder;   Attention Deficit Hyperactivity Disorder;   Intellectual DisabilityInterventions:   Diagnostic Test: Clinical evaluation;   Diagnostic Test: Neuropsychological evaluation;   Diagnostic Test: Neurophysiological evaluation;   Diagnostic Test: Genetic evaluationSponsor:   IRCCS Eugenio MedeaRecruiting

  • Clinical Effect and Safety of Autologous Umbilical Cord Blood Transfusion in the Treatment of Autism Spectrum Disorder
    on February 24, 2021 at 5:00 pm

    Condition:   Safety Issues;Effect of DrugsInterventions:   Drug: 0.9% Sodium Chloride;   Biological: Autologous Umbilical Cord BloodSponsor:   Guangdong Women and Children HospitalRecruiting

  • Role of Bumetanide in Treatment of Autism
    on February 23, 2021 at 5:00 pm

    Condition:   AutismInterventions:   Drug: Bumetanide;   Drug: PlaceboSponsor:   Sherief Abd-ElsalamRecruiting

  • A Trial of Project ImPACT in Early Intervention
    on January 28, 2021 at 5:00 pm

    Condition:   Autism Spectrum DisorderIntervention:   Behavioral: Project ImPACTSponsors:   University of Pennsylvania;   Michigan State UniversityRecruiting

  • Effect of ESDM and PCIT-A in Autism Spectrum Disorder
    on January 25, 2021 at 5:00 pm

    Condition:   Autism Spectrum DisorderInterventions:   Behavioral: Parent-Child-Interaction Therapy adapted for children with autism spectrum disorder (PCIT-A);   Behavioral: Early Start Denver Model (ESDM) intervention;   Behavioral: 1-hour ESDM;   Behavioral: Early special needs education (ESNE)Sponsors:   Bruno Rhiner;   West Virginia University;   University of ArkansasRecruiting

  • Feasibility RCT of an 8-session Group Intervention for Siblings of Children Who Have ASD
    on January 19, 2021 at 5:00 pm

    Condition:   Autism Spectrum DisorderInterventions:   Other: Sibling support group;   Other: None - control conditionSponsor:   University of SurreyRecruiting

  • Investigation of Brain Plasticity in Autism Spectrum Disorders
    on January 12, 2021 at 5:00 pm

    Condition:   Autism Spectrum DisorderInterventions:   Behavioral: Neuropsychological Testing;   Genetic: (Optional) Saliva Collection;   Device: Sensory Testing;   Device: Electroencephalogram (EEG);   Device: Transcranial Magnetic StimulationSponsors:   Boston Children's Hospital;   National Institute of Mental Health (NIMH);   Simons Foundation Autism Research Initiative (SFARI)Recruiting

Sources
  1. Autism Spectrum Disorder Data & Statistics. Retrieved from: https://www.cdc.gov/ncbddd/autism/data.html