Child Development, Communication, Social, Environmental Exposure
Conditions
Keywords
Preventative intervention, Early child development, Social communication development, Socioeconomic disadvantage, Randomized Controlled Trial
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.
Interventions
BEHAVIORALPaediatric 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.
BEHAVIORALPsychoeducation
Control participants will receive monthly psychoeducation sessions led by a developmental specialist
Sponsors
Faculdade de Medicina do ABC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
The study will be single-blinded with the researchers conducting and coding the outcome measures unaware of the intervention/control status of the study participants.
Eligibility
Sex/Gender
ALL
Age
24 Months to 59 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in parent-child interaction synchrony | Change from baseline (week 1, pre-intervention) to 5 month (post-intervention) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in neurophysiological activity during live social interaction | Change from baseline (week 1, pre-intervention) to 5 month (post-intervention) | Neurophysiological activity measured with electroencephalography (EEG) during a live play interaction between the child and an examiner |
| Change in Socialization and Communication Domain Standardized Scores on the Vineland Adaptive Behavior Scales - 3 | Change from baseline (week 1, pre-intervention) to 5 month (post-intervention) | Parent-reported measure of children's adaptive social and communication skills |
| Change in Internalizing and Externalizing Behavior Problems | Change from baseline (week 1, pre-intervention) to 5 month (post-intervention) | 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. |
| Child initiations during parent-child interaction | Change from baseline (week 1, pre-intervention) to 5 month (post-intervention) | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in developmental ability | Change from baseline (week 1, pre-intervention) to 5 month (post-intervention) | Global developmental ability measured by the Ages and Stages Questionnaire completed by primary caregivers. |
| Change in parent-child joint engagement | Change from baseline (week 1, pre-intervention) to 5 month (post-intervention) | Joint interaction behaviors between parent and child during free-play interaction measured with the Joint Engagement Rating Inventory |
| Change in style of parenting care | Change from baseline (week 1, pre-intervention) to 5 month (post-intervention) | Self-reported parenting care style measured by the Parenting Scale |
Outcome results
None listed