NCT05011240

Parent-mediated Social-communication Therapy for Young Children Living in Poverty in Brazil

A Randomized Controlled Trial of Parent-mediated Social-communication Therapy for Young Children at Risk for Neurodevelopmental Difficulties Living in Poverty in Brazil

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Faculdade de Medicina do ABC · Academic / Other
• Sex: All
• Age: 24 Months – 59 Months
• Healthy volunteers: Not accepted

Summary

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 skills act as protective factors for healthy neurodevelopment in vulnerable children. One early childhood intervention that has shown efficacy in improving early social-communication development is Paediatric Autism Communication Therapy (PACT). However, there are no studies testing the efficacy of PACT in Latin American countries where environmental risk factors are common. This randomized controlled trial will test the efficacy of PACT in improving social-communication development in young children at risk for neurodevelopmental difficulties due to living in socio-economically disadvantaged regions of São Paulo, 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 (social-communication abilities assessed with the Vineland, neurophysiological activity during a live social interaction) will be measured pre- and post-intervention. All procedures will be performed in accordance with the CONSORT declaration for non-pharmacological interventions.

Conditions

• Child Development
• Communication, Social
• Environmental Exposure

Interventions

Type	Name	Description
BEHAVIORAL	Paediatric Autism Communication Therapy (PACT)	PACT is a parent-mediated therapy that aims to improve children's social-communication development. During PACT, a therapist uses video-feedback of parent-child play interactions to coach the parent in how to improve their sensitivity and responsiveness to their child's social-communication and interaction behaviours and to implement evidence-based strategies that facilitate social-communication development.
BEHAVIORAL	Psychoeducation	Control participants will receive monthly psychoeducation sessions led by a developmental specialist

Timeline

• Start date: 2022-01-01
• Primary completion: 2023-06-01
• Completion: 2023-06-01
• First posted: 2021-08-18
• Last updated: 2021-11-09