Intranasal Oxytocin + Social Skills Group Therapy Explored for Autism Spectrum Disorder

Individuals with autism spectrum disorder (ASD) often experience significant challenges in social cognition and function, impacting their daily lives and quality of relationships. Current interventions, while beneficial, frequently leave substantial gaps in addressing core social deficits. Oxytocin, a neuropeptide known for its role in social bonding and behavior, has emerged as a promising therapeutic target for modulating social cognition in neurodevelopmental disorders. This study aims to explore whether augmenting social cognitive skills group therapy with targeted intranasal oxytocin dosing can enhance social outcomes in school-aged children with ASD, addressing a critical need for more effective treatment strategies.

This Phase 4, randomized, placebo-controlled clinical trial enrolled 120 school-aged children with autism spectrum disorder (ASD). Participants received either intranasal oxytocin or placebo, integrated with a social cognitive skills group therapy program. The study's primary objective was to evaluate the feasibility, safety, and preliminary efficacy of this combined intervention. Efficacy was assessed over 12 weeks by measuring changes in social cognition and social function. The trial design included a comparator arm receiving placebo alongside the same social cognitive skills group therapy, allowing for a direct comparison of oxytocin's contribution to therapeutic outcomes.

The study aims to evaluate the efficacy of intranasal oxytocin versus placebo on measures of social cognition and social function over 12 weeks. Secondary outcomes include the efficacy of intranasal oxytocin versus placebo on measures of social cognition and social function, both assessed at 12 weeks. Social function was specifically measured by a change in score on the Aberrant Behavior Checklist (ABC) - Social Withdrawal Subscale. This subscale ranges from 0-48, where lower scores indicate improvement in social withdrawal. As of the abstract, specific findings regarding these efficacy endpoints, as well as detailed feasibility and safety data, have not yet been reported. The trial is completed, and results are anticipated to elucidate whether oxytocin significantly modulates social behaviors in this population when combined with group therapy. The study is also investigating the relationship between oxytocin effects on social cognition training and target engagement.