Social communication therapy for children at risk for neurodevelopmental difficulties: Protocol for a clinical trial.

Exposure to adverse environments are risk factors for neurodevelopmental problems in childhood. Children exposed to such environments may benefit from interventions that target social communication abilities, since these are protective factors for healthy neurodevelopment. This randomized controlled trial will test the efficacy of Paediatric Autism Communication Therapy (PACT) in improving social communication development in young children at risk for neurodevelopmental difficulties living in poverty in Brazil. Participants will be 160 children aged 2-4 years with lower-than-average social communication abilities and their primary caregivers. Child-caregiver dyads will be recruited from public childhood education centers in impoverished urban regions of the city of São Paulo, Brazil. Lower-than-average social communication abilities will be defined by standard scores (≤84) on the socialization and/or communication domains of the Vineland Adaptive Behavior Scales. Child-caregiver dyads will be randomized to receive 12 sessions of the PACT intervention (n = 80) or 5 months of community support as usual plus psychoeducation (n = 80). The primary outcome (parent-child interaction) and secondary outcomes (parent-reported social communication abilities and neurophysiological activity during a live social interaction) will be measured pre- and postintervention. This study may lead to new interventions for vulnerable young children in Brazil and better understanding of the neural mechanisms of PACT.