Impact of Combined Medication and Behavioral Treatment for ASD & ADHD

PHASE2TerminatedINTERVENTIONAL
Enrollment

18

Participants

Timeline

Start Date

December 14, 2018

Primary Completion Date

December 28, 2020

Study Completion Date

April 19, 2021

Conditions
Autism Spectrum DisorderAttention Deficit Hyperactivity Disorder
Interventions
DRUG

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.

BEHAVIORAL

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).

DRUG

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.

Trial Locations (1)

27705

Duke Center for Autism and Brain Development, Durham

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

lead

Duke University

OTHER

NCT03242772 - Impact of Combined Medication and Behavioral Treatment for ASD & ADHD | Biotech Hunter | Biotech Hunter