18
Participants
Start Date
December 14, 2018
Primary Completion Date
December 28, 2020
Study Completion Date
April 19, 2021
Amphetamine
Study drug will be administered in the morning. Treatment will be initiated at 1 tablet = 3.1 mg or 0 mg of mixed amphetamine. Doses will be flexibly titrated upward and may be decreased or stopped at any time.
ESDM informed parent coaching
All participants will receive 8 weekly parent child therapy sessions will be delivered by a therapist trained in parent coaching and ESDM principles and strategies and utilizing a therapy manual,(includes coaching for behavior management and handouts).
Placebo Oral Tablet
Matched placebo tablets will be administered in the morning and provided for 11 weeks . The tablets will be titrated in the same way as the active drug and may be stopped at any time.
Duke Center for Autism and Brain Development, Durham
Lead Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Duke University
OTHER