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

Study Overview
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Brief Summary
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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.

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

Conditions
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Child Development, Communication, Social, Environmental Exposure

Intervention / Treatment
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* Behavioral: Paediatric Autism Communication Therapy (PACT)
* Behavioral: Psychoeducation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 24 Months
Maximum Age: 59 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Preventative intervention, Early child development, Social communication development, Socioeconomic disadvantage, Randomized Controlled Trial