CART ACE II - Project 3: Augmenting language interventions for ASD: A translational approach

Project summary

Overview: This new project in the ACE Center directly addresses the goals of the IACC to increase the number of controlled intervention studies addressing key needs of individuals with Autism Spectrum Disorder (ASD).

ACE Project 3 Summary:  This study reflects the overarching goal of enhancing interventions that address core communication deficits common in children with ASD. Despite earlier diagnosis and increased awareness of the importance of early intervention, language and communication outcomes remain highly variable in ASD, with some longitudinal samples showing as many as 50% of children diagnosed with autism at age 2 are still nonverbal or lacking phrase speech by age 9 (Anderson et al., 2007). Despite the importance of such an unmet treatment need, few studies have empirically tested the possible additive effects of combined treatments, especially combined psychosocial and medical interventions, which the current study is designed to do.

This innovative project tests the hypothesized benefits of the addition of the dopamine-stabilizing drug, aripiprazole (ARI) versus placebo, on short-term social communication and language outcomes in 6-11 year old children with ASD who lack phrase speech and receive an intensive, developmentally informed language intervention.  Drawing from converging lines of evidence suggeseting abnormalities in social motivation and reward responsivity in ASD, and behavioral moderators of treatment response in ASD, this translational study willl test for a hypothesized positive effect of ARI administration, based on effects on social motivation, in combination with a state-of-the-art communication intervention in children with ASD and low language ability.

Findings from this study are hoped to inform an empirically based approach to choices of intervention for school age children with ASD and low language ability. The study also should represent a trial design that could serve as a platform for future studies of targeted treatments for ASD, identified by anticipated new understandings of the core pathophysiology. If this proof-of-concept clinical trial suggests that ARI facilitates language acquisition in ASD, such a result could have clinical implications once replicated in a larger controlled study.

Investigators
Primary Investigator: 
James McCracken, M.D.
Primary Investigator: 
Connie Kasari, Ph.D.