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

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  • Latest clinical trials
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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

  • Effect of PLAY Project Intervention Program on Children With ASD
    on September 8, 2022 at 4:00 pm

    Condition:   Autism Spectrum DisorderInterventions:   Behavioral: PLAY Project;   Behavioral: Parental EducationSponsors:   Tongji Hospital;   Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology;   Fuzhou Children's Hospital of Fujian Medical University;   Third Affiliated Hospital of Zhengzhou University;   Shenzhen Hospital of Southern Medical University;   Children's Hospital of Zhejiang University School of MedicineRecruiting

  • Pimavanserin for the Treatment of Irritability Associated With Autism Spectrum Disorder
    on August 31, 2022 at 4:00 pm

    Condition:   Irritability Associated With Autism Spectrum DisorderInterventions:   Drug: Pimavanserin;   Drug: PlaceboSponsor:   ACADIA Pharmaceuticals Inc.Recruiting

  • Autism Spectrum Disorder: BAEPs Findings and Behavioral Responses to Sounds
    on August 30, 2022 at 4:00 pm

    Condition:   Autism Spectrum DisorderIntervention:   Diagnostic Test: Brainstem Auditory Evoked PotentialsSponsor:   Instituto de Ciências Biomédicas Abel SalazarRecruiting

  • Transdiagnostic Group Therapy (GBAT) for Autistic Adults With Personalized Therapeutics
    on August 23, 2022 at 4:00 pm

    Conditions:   GBAT+Individual;   GBAT+Engagement Booster;   GBAT+BothInterventions:   Other: GBAT+I, GBAT+E - Phase I;   Other: Watchful Waiting and Groups - Phase 2;   Other: GBAT+IESponsors:   Rutgers, The State University of New Jersey;   New Jersey Governor's Council for Medical Research and Treatment of AutismRecruiting

  • Pivotal Response Intervention Minimal Responders Study
    on August 22, 2022 at 4:00 pm

    Condition:   Autism Spectrum Disorder With Impaired Functional LanguageInterventions:   Behavioral: PRIMeR;   Behavioral: PRTSponsors:   IWK Health Centre;   Canadian Institutes of Health Research (CIHR)Recruiting

  • Brain and Oculometric Markers of Emotional Facial Expression Recognition Deficits
    on August 15, 2022 at 4:00 pm

    Conditions:   Autism;   Psychotic DisordersIntervention:   Other: Electroencephalogram and eye-tracking recordingsSponsor:   Hôpital le VinatierRecruiting

  • Development and Evaluation of "Period Kits" for Adolescents With Intellectual and Developmental Disabilities
    on August 11, 2022 at 4:00 pm

    Conditions:   Autistic Spectrum Disorder;   Patient Empowerment;   Menstrual DiscomfortIntervention:   Other: Period KitSponsors:   Tufts Medical Center;   Tufts UniversityRecruiting

  • Characterizing Occupational Therapy Intervention for Children With Autism Spectrum Disorders
    on July 29, 2022 at 4:00 pm

    Condition:   Autism Spectrum DisorderIntervention:   Behavioral: Occupational TherapySponsors:   Ohio State University;   American Occupational Therapy Foundation;   Nationwide Children's HospitalRecruiting

  • Exergaming on Hand Dexterity In Autistic Children
    on July 26, 2022 at 4:00 pm

    Condition:   Autism Spectrum DisorderInterventions:   Other: Exergaming;   Other: Conventional Dexterity ExercisesSponsor:   Riphah International UniversityRecruiting

  • Super: a Joint System in a Rehabilitation Educational Digital Platform
    on July 26, 2022 at 4:00 pm

    Conditions:   Autism Spectrum Disorder;   TelerehabilitationIntervention:   Behavioral: SUPER digital platformSponsor:   University of Milano BicoccaRecruiting

  • MRI Study of Subjects With ASD, Their Relatives and TD
    on July 22, 2022 at 4:00 pm

    Condition:   Autism Spectrum DisorderIntervention:   Other: Neuroimaging (MRI)Sponsors:   Institut National de la Santé Et de la Recherche Médicale, France;   APHP;   Institut Pasteur;   Commissariat A L'energie AtomiqueRecruiting

  • PACT Programme for Parents of Children With SHCN
    on July 20, 2022 at 4:00 pm

    Conditions:   Urologic Diseases;   Gastrointestinal Diseases;   Vascular Diseases;   Cleft Lip and Palate;   Neurodevelopmental Disorders;   Attention Deficit Hyperactivity Disorder;   Autism Spectrum Disorder;   Developmental DelayInterventions:   Behavioral: Prosocial-orientated Acceptance and Commitment Training plus positive parenting advice;   Behavioral: Positive parenting adviceSponsors:   Chinese University of Hong Kong;   Hong Kong Children's Hospital;   Hong Kong Young Women's Christian AssociationRecruiting

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