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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.

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.

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

  • [email protected] Balance Rehabilitation of Autistic Children With Virtual rEality
    on February 19, 2020 at 5:00 pm

    Condition:   Autism Spectrum DisorderIntervention:   Device: exergames with GRAIL virtual immersive reality environmentSponsor:   IRCCS Eugenio MedeaRecruiting

  • Early Screening of Autism Spectrum Disorder in General and Pediatric Practices
    on February 18, 2020 at 5:00 pm

    Condition:   Autism Spectrum DisorderIntervention:   Diagnostic Test: early detection kit composed of 2 questionnaires (M-CHAT-R + CSBS-ITC)Sponsor:   Hôpital le VinatierRecruiting

  • Genome Environment Microbiome and Metabolome in Autism Study
    on February 17, 2020 at 5:00 pm

    Condition:   Autism Spectrum DisorderIntervention:   Sponsors:   Massachusetts General Hospital;   Azienda Sanitaria Locale Salerno;   National University of Ireland, Galway, IrelandRecruiting

  • Brexpiprazole in Treatment of Children and Adolescents With Irritability Associated With Autism Spectrum Disorder for Subjects That Have Completed Participation in 331-201-00148
    on February 6, 2020 at 5:00 pm

    Condition:   Irritability Associated With Autism Spectrum DisorderIntervention:   Drug: BrexpiprazoleSponsors:   Otsuka Pharmaceutical Development & Commercialization, Inc.;   H. Lundbeck A/SRecruiting

  • Effectiveness of the WHO Caregivers Skills Training Program
    on February 5, 2020 at 5:00 pm

    Conditions:   Autism Spectrum Disorder;   Development Delay;   Developmental Disorder;   Language Delay;   Behavioral Problem;   Emotional Problem;   Maternal DistressInterventions:   Behavioral: WHO Caregiver skills training (CST) program;   Behavioral: Treatment as usualSponsors:   Human Development Research Foundation, Pakistan;   World Health Organization;   University of Liverpool;   WHO Collaborating Center for mental health research, Institute of Psychiatry, Rawalpindi, PakistanRecruiting

  • Sustainable Mindfulness and Resilience Training (SMART)
    on January 28, 2020 at 5:00 pm

    Conditions:   Caregiver Stress;   Autism Spectrum DisorderIntervention:   Behavioral: Mindfulness trainingSponsor:   University of California, San FranciscoRecruiting

  • Transcranial Magnetic Stimulation on Neural and Behavioral Facets of Social Cognition in Autism Spectrum Disorder
    on January 27, 2020 at 5:00 pm

    Condition:   Autism Spectrum DisorderIntervention:   Behavioral: Transcranial Magnetic Stimulation (TMS)Sponsor:   Yale UniversityRecruiting

  • Effect of rTMS on the Abnormal Executive Function of ASD Children
    on January 23, 2020 at 5:00 pm

    Conditions:   Executive Dysfunction;   ASDInterventions:   Device: Active cTBS;   Device: ShamSponsor:   Xinhua Hospital, Shanghai Jiao Tong University School of MedicineRecruiting

  • Improving Working Memory of Children With Autism
    on December 24, 2019 at 5:00 pm

    Condition:   AutismInterventions:   Behavioral: Rehearsal strategy;   Behavioral: Reinforcement;   Behavioral: Rehearsal strategy and reinforcementSponsors:   Arizona State University;   Shanghai Xuhui Clover Children Healthy Garden;   Jingdezhen Kindkids Autism Rehabilitation and Training Center;   Sunshine Special Education CenterRecruiting

  • Autism and Disruptive Behavior Trial
    on December 18, 2019 at 5:00 pm

    Conditions:   ASD;   Child Behavior ProblemInterventions:   Behavioral: Social Worker;   Behavioral: Autism Behavioral Health Navigation (ABHN);   Behavioral: Social work + ABHN;   Behavioral: Social work + ABHN + CAPSponsors:   Children's Hospital of Philadelphia;   Eagles Autism Challenge, Inc;   University of PennsylvaniaRecruiting

  • Physical Fitness in Autism
    on December 16, 2019 at 5:00 pm

    Condition:   AutismIntervention:   Other: physical fitness assessmentSponsor:   Hacettepe UniversityRecruiting

  • Iterative Redesign of a Behavioral Skills Training Program for Use in Educational Settings
    on December 16, 2019 at 5:00 pm

    Conditions:   Autism Spectrum Disorder;   Disruptive BehaviorInterventions:   Behavioral: RUBI;   Behavioral: RUBIESSponsors:   University of Washington;   National Institute of Mental Health (NIMH)Recruiting

  • Sensors for Communication for Persons Who Cannot Communicate Unequivocally
    on December 13, 2019 at 5:00 pm

    Conditions:   Intellectual Disability;   Autism;   Cerebral PalsyIntervention:   Device: Heart rate and respiration rate sensorsSponsor:   University of OsloRecruiting

  • MTT for Children With ASD Who Have Gastrointestinal Disorders
    on December 2, 2019 at 5:00 pm

    Conditions:   Autism Spectrum Disorder;   Gastro-Intestinal Disorder;   Constipation;   DiarrheaInterventions:   Combination Product: vancomycin, Miralax, intestinal microbiota;   Combination Product: placebo vancomycin, Miralax, placebo intestinal microbiotaSponsors:   Arizona State University;   Arizona State University Foundation;   University of Minnesota;   Finch TherapeuticsRecruiting

  • Advocating for Supports to Improve Service Transitions
    on November 22, 2019 at 5:00 pm

    Conditions:   Autism Spectrum Disorder;   AutismIntervention:   Behavioral: ASSISTSponsors:   Vanderbilt University Medical Center;   University of Illinois at Urbana-Champaign;   University of Wisconsin, MadisonRecruiting

  • Brexpiprazole in Treatment of Children and Adolescents With Irritability Associated With Autism Spectrum Disorder
    on November 22, 2019 at 5:00 pm

    Condition:   Irritability Associated With Autism Spectrum Disorder (ASD)Interventions:   Drug: Brexpiprazole;   Drug: PlaceboSponsors:   Otsuka Pharmaceutical Development & Commercialization, Inc.;   H. Lundbeck A/SRecruiting

  • Brain Response to Serotonergic Medications in ASD
    on October 30, 2019 at 4:00 pm

    Condition:   Autism Spectrum DisorderInterventions:   Drug: Placebo;   Drug: Citalopram;   Drug: TianeptineSponsor:   King's College LondonRecruiting

  • An Explorative RVA of the Motor Development of Children With DCD <2y
    on October 15, 2019 at 4:00 pm

    Conditions:   Developmental Coordination Disorder;   Autism Spectrum DisorderInterventions:   Diagnostic Test: Movement Assessment Battery for Children 2(M-ABC-2);   Diagnostic Test: Developmental Coordination Disorder - Questionnaire (DCD-Q);   Diagnostic Test: Social Responsiveness Scale 2 (SRS-2);   Other: Retrospective Video AnalysisSponsor:   University GhentRecruiting

  • DCD & ASD Imaging Intervention Study
    on October 8, 2019 at 4:00 pm

    Conditions:   Motor Skills Disorders;   Autism Spectrum DisorderIntervention:   Behavioral: CO-OP Treatment GroupSponsors:   University of British Columbia;   Waterloo FoundationRecruiting

  • PEERS© for Careers
    on October 3, 2019 at 4:00 pm

    Condition:   Autism Spectrum DisorderInterventions:   Behavioral: Never Coach;   Behavioral: Internship Only Coach;   Behavioral: Didactic Only Coach;   Behavioral: Constant CoachSponsor:   University of California, Los AngelesRecruiting

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