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

ABC Foundation (FUABC)

Status: Unknown

Conditions: Environmental Exposure; Child Development; Communication, Social

Treatments: Behavioral: Paediatric Autism Communication Therapy (PACT); Behavioral: Psychoeducation

Study type: Interventional

Funder types: Other

Identifiers

NCT05011240

45672321.0.0000.0068

Details and patient eligibility

About

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.

Enrollment: 160 estimated patients

Sex: All

Ages: 24 to 59 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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160 participants in 2 patient groups

Paediatric Autism Communication Therapy (PACT) Intervention plus Community Assistance as Usual

Experimental group

Description:

Participants will receive 12 sessions over 5 months of Paediatric Autism Communication Therapy (PACT).

Treatment:

Behavioral: Paediatric Autism Communication Therapy (PACT)

Community support as usual plus psychoeducation (Control)

Active Comparator group

Description:

Participants in the Control group will receive psycho-educational support via monthly sessions led by researchers with experience in child development. In each session, a presentation will be delivered to provide parents with information about child development and environmental factors that contribute to healthy child development, including sensitive parenting styles, frequent positive social interactions between parents and children and cognitive stimulation. The presentations will be followed by group discussions. Children will also continue to receive Community Assistance as Usual via their normal early education centers. These centers offer daily activities designed to promote children's learning, autonomy, movement, integration and socialization. Children attend their educational center five days per week between the hours of 8am and 5pm.

Treatment:

Behavioral: Psychoeducation