Trial of Diphenhydramine for Sleep in Children With Autism

Inclusion Criteria

• •Participants will meet the following
• •Outpatients between 8 and 17 years of age at the time of consent
• •Diagnostic and Statistical Manual, 5th edition (DSM-5) criteria for Autism Spectrum Disorder (ASD) on the basis of clinical evaluation, confirmed with the Autism Diagnostic Interview-Revised (ADI-R) and the Autism Diagnostic Observation Schedule, 2nd Ed (ADOS-2) or the Childhood Autism Rating Scale, Second Edition (CARS-2).
• •Males and females
• •Availability of polysomnography (PSG) or actigraphy data
• •Sleep disturbances as assessed using Children's Sleep Habits Questionnaire (CSHQ) with a score of 41 or higher
• •care provider who can reliably bring participant to clinic visits, provide trustworthy ratings, and interacts with participant on a regular basis
• •stable medications for at least 2 weeks, with the exception of Prozac which is required to be stable for at least 4 weeks
• •no planned changes in psychosocial and biomedical interventions during the trial
• •willingness to provide additional saliva samples and participate in key study procedures (i.e., safety measurements every visit, PSG at weeks 4 and 8, and wear the actigraphy watch for 2 weeks before the beginning of trial as well as during the 8 weeks of the trial).