Last updated: September 11, 2022
Sponsor: Stanford University
Overall Status: Terminated
Phase
N/A
Condition
Autism
Asperger's Disorder
Williams Syndrome
Treatment
N/AClinical Study ID
NCT03131635
IRB 40026
Ages 2-5 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Diagnosis of Autism Spectrum Disorder based on Autism Diagnostic Interview Revised (ADI-R), Autism Diagnostic Observation Schedule (ADOS-2), DSM-5, and expert clinicalopinion;
- Males and females in good medical health between 2.0 and 5 years 11 months;
- Ability to participate in the testing procedures to the extent that valid standardscores can be obtained;
- Stable treatment (e.g., applied behavior analysis), speech therapy, psychotropicmedication(s) or biomedical intervention(s) for at least 1 month prior to baselinemeasurements with no anticipated changes during study participation;
- Availability of at least one English-speaking parent who can consistently participatein parent training and research measures;
- Clinical Global Impression(CGI) Severity Social Interaction and CommunicationIntegrated Subscale ≥4;
- Meet the cutoff for Autism on the ADOS-2.
Exclusion
Exclusion Criteria:
- Current or lifetime diagnosis of severe psychiatric disorder (e.g., bipolar disorder,etc.);
- A well-established genetic syndrome, such as Fragile X;
- Presence of active medical problem (e.g., unstable seizure disorder or heart disease);
- Child's primary language other than English;
- Previous adequate trial or training of a developmentally based intervention;
- Participants living more than 45 miles from Stanford University;
- Children with more than 20 hours of in-home ABA;
- At least one room of the house must be available to be dedicated to treatment duringsession times;
- There must be no serious health and safety risks present in the home environment;
- The research team has the right to refuse to perform sessions in-home even if thecriteria above are met.
Study Design
Total Participants: 54
Study Start date:
July 26, 2017
Estimated Completion Date:
July 16, 2020
Connect with a study center
Stanford University
Stanford, California 94305-5719
United StatesSite Not Available

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