Oxytocin therapy in children with autism spectrum disorder and co-occurring intellectual disability: examination of desirability, clinical efficacy and therapeutic augmentation by psychosocial training

Intranasal administration of oxytocin is increasingly considered a new therapeutic resource for autism spectrum disorder (ASD). Prior oxytocin trials have however mostly excluded autistic individuals with co-occurring intellectual disability (ID) by design, despite making up 40% of the ASD population and often displaying more severe symptoms. Therefore, we propose a RCT assessing the clinical effects of a multiple-dose oxytocin intervention (4 weeks of 3 times weekly intranasal administrations of 24 IU) on core autism symptoms in 80 children with ASD+ID (7-12 years, IQ<75) (40 oxytocin, 40 placebo). In light of emerging insights that treatment outcome might be impacted by the context in which oxytocin is administered, administration will be paired with psychosocial training, allowing to further elucidate the potential of augmenting the clinical benefits by administrating oxytocin within a socially stimulating context. Moreover, additional qualitative interviews with caretakers will allow novel understanding of the desirability, perspectives, expectations and experiences regarding oxytocin therapy for children with ASD. In summary, our quantitative and qualitative evaluation will provide first insights into oxytocin’s clinical efficacy and mediation by context, its desirability and applicability in the pediatric ASD+ID population. These insights are essential for oxytocin’s promising implementation into the clinical practice for ASD within an early life developmental window.