Clinical trial NCT05011240: Parent-mediated Social-communication Therapy for Young Children Living in Poverty in Brazil
Official title: A Randomized Controlled Trial of Parent-mediated Social-communication Therapy for Young Children at Risk for Neurodevelopmental Difficulties Living in Poverty in Brazil
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Child Development
Communication, Social
Environmental Exposure
Keywords: Preventative intervention
Early child development
Social communication development
Socioeconomic disadvantage
Randomized Controlled Trial
Lead sponsor: Faculdade de Medicina do ABC
Sponsor class: OTHER
First posted: 2021-08-18
Enrollment: 160
Sex: ALL
Minimum age (years): 24
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: Inclusion Criteria:

* aged 2 years 0 months to 4 years 11 months
* low social-communication abilities indexed by Standardized Scores between 55 to 84 on the Socialization and/or Communication Domains of the Vineland Adaptive Behavior Scales - Third Edition
* parent/primary caregiver agrees to participate in the trial

Exclusion Criteria:

* known neurological condition such as epilepsy
* known genetic disorder such as Down Syndrome
* hearing or visual impairment in the parent or child that could interfere with the intervention
* self-reported current psychiatric or neurological disorder in the parent that could interfere with the intervention

Primary outcomes:
measure: Change in parent-child interaction synchrony
timeFrame: Change from baseline (week 1, pre-intervention) to 5 month (post-intervention)
Secondary outcomes:
measure: Change in Socialization and Communication Domain Standardized Scores on the Vineland Adaptive Behavior Scales - 3
timeFrame: Change from baseline (week 1, pre-intervention) to 5 month (post-intervention)
measure: Change in neurophysiological activity during live social interaction
timeFrame: Change from baseline (week 1, pre-intervention) to 5 month (post-intervention)
measure: Change in Internalizing and Externalizing Behavior Problems
timeFrame: Change from baseline (week 1, pre-intervention) to 5 month (post-intervention)
measure: Child initiations during parent-child interaction
timeFrame: Change from baseline (week 1, pre-intervention) to 5 month (post-intervention)
Other outcomes:
measure: Change in style of parenting care
timeFrame: Change from baseline (week 1, pre-intervention) to 5 month (post-intervention)
measure: Change in parent-child joint engagement
timeFrame: Change from baseline (week 1, pre-intervention) to 5 month (post-intervention)
measure: Change in developmental ability
timeFrame: Change from baseline (week 1, pre-intervention) to 5 month (post-intervention)
Locations:
Study officials:
References:
citation: Godoy PBG, Shephard E, Argeu A, Silveira LR, Salomone E, Aldred C, Green J, Polanczyk GV, Matijasevich A. Social communication therapy for children at risk for neurodevelopmental difficulties: Protocol for a clinical trial. Ann N Y Acad Sci. 2022 Aug;1514(1):104-115. doi: 10.1111/nyas.14784. Epub 2022 May 4.