Oxytocin and Social Cognitive Skills Groups
Condition: Autism Spectrum Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the feasibility, safety, and preliminary efficacy of
      integrating targeted dosing of intranasal oxytocin with a social cognitive skills group
      therapy for school-aged children with autism spectrum disorder (ASD).
    

Detailed description: 
      The study is a proof-of-concept, combination intervention designed to address individual
      treatment targets presumed to influence social learning in school-aged children with autism
      spectrum disorder (ASD). This proposal builds upon prior research on an empirically supported
      social cognitive skills training curriculum, NETT (Nonverbal communication, Emotion
      recognition, and Theory of mind Training). NETT is a cognitive-behavioral intervention (CBI)
      for nonverbal communication, emotion recognition, and theory of mind deficits in youth with
      ASD. In this two-phase, 3 year, single-blind, contact controlled study, school-aged children
      with ASD (n=60) will be randomized into a 12-session, parallel group design of Integrated
      Oxytocin and NETT (ION) or a control social group condition (facilitated play). The study
      aims to evaluate the safety, tolerability, and efficacy of integrating the neuropeptide,
      oxytocin (OT), with the social cognitive curriculum, as well as to identify targets of change
      and pre-treatment factors predictive of response to ION-ASD. Maintenance of treatment effects
      will also be assessed 1 month and 3 months post-treatment.
    

Intervention name(s): Oxytocin; Social Cognitive Skills Training; Facilitated Play Therapy
Intervention type(s): Drug; Behavioral; Behavioral
Intervention description(s): This is an integrated pharmacological-behavioral intervention targeting social cognitive skills for school-aged children with ASD. Four doses of intranasal oxytocin (24 IUs/dose) will be delivered each week before weekly homework and group therapy sessions.; Social cognitive skills training utilize cognitive behavioral strategies such as problem identification, affective education, performance feedback, and weekly homework activities to target impairments in nonverbal synchrony, emotional expression, and interpretation of intent. The NETT curriculum is manualized and anchored in CBI strategies, such as problem identification, affective education, performance feedback, and weekly homework activities. Parent education sessions run concurrently with child groups to help facilitate generalization.; The facilitated play therapy group is a manualized treatment designed to tailor play to the interests and abilities of group members. Therapists use general therapeutics strategies such as reflective functioning statements to foster communication with therapists as well as between peers. Standard educational practices for children with ASD such as visual supports, schedules, and short-directed statements are also used. The concurrent parent group is supportive in nature.
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Autism Spectrum Disorder; Oxytocin; Social Skills; Social cognitive skills; Cognitive Behavioral Intervention; Combination treatment; Syntocinon; NETT (Nonverbal communication, Emotion recognition, Theory of mind Training); emotion recognition; theory of mind