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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Child Development; Environmental Exposure; Communication, Social
• Intervention / Treatment: Behavioral: Paediatric Autism Communication Therapy (PACT); Behavioral: Psychoeducation

• Study Type: Interventional
• Enrollment (Anticipated): 160
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 4 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Paediatric Autism Communication Therapy (PACT) Intervention plus Community Assistance as Usual; Participants will receive 12 sessions over 5 months of Paediatric Autism Communication Therapy (PACT).	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.
Active Comparator: Community support as usual plus psychoeducation (Control); 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.	Behavioral: Psychoeducation; Control participants will receive monthly psychoeducation sessions led by a developmental specialist

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in parent-child interaction synchrony	Parent-child interaction synchrony will be measured during a 10-minute free-play interaction between the primary caregiver and child and coded using the Dyadic Communication Measure for Autism (DCMA). Synchrony is coded as the proportion of communicative behaviors of the primary caregiver that elicit responses from the child.	Change from baseline (week 1, pre-intervention) to 5 month (post-intervention)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Socialization and Communication Domain Standardized Scores on the Vineland Adaptive Behavior Scales - 3	Parent-reported measure of children's adaptive social and communication skills	Change from baseline (week 1, pre-intervention) to 5 month (post-intervention)
Change in neurophysiological activity during live social interaction	Neurophysiological activity measured with electroencephalography (EEG) during a live play interaction between the child and an examiner	Change from baseline (week 1, pre-intervention) to 5 month (post-intervention)
Change in Internalizing and Externalizing Behavior Problems	Internalizing and externalizing behaviour problems measured by parent-report on the Child Behavior Checklist 1.5-5 and on the Strengths and Difficulties Questionnaire 2-4.	Change from baseline (week 1, pre-intervention) to 5 month (post-intervention)
Child initiations during parent-child interaction	Child initiations will be measured during a 10-minute free-play interaction between the primary caregiver and child and coded using the Dyadic Communication Measure for Autism (DCMA). Child initiations are coded as the proportion of the child's spontaneous communicative behaviors oriented to the parent, including verbal and non-verbal behaviors.	Change from baseline (week 1, pre-intervention) to 5 month (post-intervention)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in style of parenting care	Self-reported parenting care style measured by the Parenting Scale	Change from baseline (week 1, pre-intervention) to 5 month (post-intervention)
Change in parent-child joint engagement	Joint interaction behaviors between parent and child during free-play interaction measured with the Joint Engagement Rating Inventory	Change from baseline (week 1, pre-intervention) to 5 month (post-intervention)
Change in developmental ability	Global developmental ability measured by the Ages and Stages Questionnaire completed by primary caregivers.	Change from baseline (week 1, pre-intervention) to 5 month (post-intervention)

Collaborators and Investigators

• Sponsor: Faculdade de Medicina do ABC

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2022
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: August 16, 2021
• First Submitted That Met QC Criteria: August 16, 2021
• First Posted (Actual): August 18, 2021

Study Record Updates

• Last Update Posted (Actual): November 9, 2021
• Last Update Submitted That Met QC Criteria: November 5, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Randomized Controlled Trial; Early child development; Preventative intervention; Social communication development; Socioeconomic disadvantage
• Other Study ID Numbers: 45672321.0.0000.0068

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No