A Randomized Controlled Trial of Parent-mediated Social-communication Therapy for Young Children at Risk for Neurodevelopmental Difficulties Living in Poverty in Brazil
试验速览
- 阶段
- 不适用
- 入组人数
- 160
- 主要终点
- Change in parent-child interaction synchrony
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 24 Months 至 59 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change in parent-child interaction synchrony
时间窗: 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.
次要结局
- Child initiations during parent-child interaction(Change from baseline (week 1, pre-intervention) to 5 month (post-intervention))
- Change in neurophysiological activity during live social interaction(Change from baseline (week 1, pre-intervention) to 5 month (post-intervention))
- Change in Internalizing and Externalizing Behavior Problems(Change from baseline (week 1, pre-intervention) to 5 month (post-intervention))
- 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))
研究者
Alicia Matijasevich
Associate Professor in Preventative Medicine
Faculdade de Medicina do ABC