Parent-mediated social communication therapy for young children at risk for neurodevelopmental difficulties living in poverty in Brazil: study protocol for a randomized controlled trial

Background: Exposure to adverse environments such as socioeconomic disadvantage and psychosocial deprivation 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 in vulnerable children. One intervention that has shown efficacy in improving early social-communication development is Paediatric Autism Communication Therapy (PACT). However, the efficacy of PACT has not been tested for vulnerable children exposed to environmental risk-factors in Latin American countries. This randomized controlled trial will test the efficacy of PACT in improving social-communication development in young children at risk for neurodevelopmental difficulties living in poverty in Brazil.Methods: Participants will be 160 children aged 2 years 0 months to 4 years 11 months with low social-communication abilities and their primary caregivers. Child-caregiver dyads will be recruited from public early childhood education centers in impoverished urban regions of the city of São Paulo, Brazil. Low 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 (five months) of the PACT intervention (N=80) or five months of community support as usual plus psychoeducation (N=80). The primary outcome (parent-child interaction) and secondary outcomes (parent-reported social-communication abilities, neurophysiological activity during a live social interaction) will be measured pre- and post-intervention. Discussion: This study may lead to new interventions for vulnerable young children in Brazil and better understanding of the neural mechanisms of PACT.