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

NCT05011240 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2021-11-09

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Faculdade de Medicina do ABC

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
24 Months
Max Age
59 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-01
Primary Completion
2023-06-01
Completion
2023-06-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05011240 on ClinicalTrials.gov