Pilot Community-based Development Intervention (CASITA) for Children With Neurodevelopmental Risk and Delay in Carabayllo, Lima, Peru
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 61
- 主要终点
- Change in risk of delay, as measured by the EASQ
研究概览
简要总结
Building on an intervention for early child development from the SPARK Center in Boston, Socios En Salud (SES) pilot tested "CASITA" a community-based package to screen and treat young children (ages 1-3 years of age) diagnosed with neurodevelopment risk and delay in Carabayllo, Lima, Peru. Ministry of Health CHWs identified children with developmental delays within the clinics and community and delivered a structured early intervention that included parent coaching and social support. In order to test the hypothesis that CASITA improves early child development, caregiver, and home environment, dyads received either nutrition supplements alone, nutrition + "CASITA" early child development sessions individually, or CASITA in a group of 10 dyads.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 6 - 24 months of age;
- •Known primary caregiver (parent or legal guardian) living with child;
- •Living within the catchment area of the 6 Health Centers that comprise the study zone.
- •Screen positive for neurodevelopment delay ("at risk" or "delayed" in neurodevelopment based on Evaluation del Desarrollo Psicomotor (EEDP) assessment).
- •Be at risk by scoring <45 on the Progress Out of Poverty Index.
排除标准
- •A known medical condition that would make the child unresponsive to early intervention;
- •Family anticipates moving within the next three months.
研究组 & 干预措施
Nutrition only
Monthly food baskets were provided to the nutrition only group. Food baskets included basic foods to sustain a family of three over one month's time, such as rice and evaporated milk. Food baskets were valued at approximately $28 US Dollars per basket.
Nutrition + CASITA
The CASITA intervention was given by a community health worker (CHW) and involves individual and group modalities. HOME-CASITA took place at the dyad's place of residence, and the GROUP-CASITA at a local community center. All CASITA participants received 12 weekly sessions over 3 months. Interventions retain core elements of the SPARK approach: coaching parents on child development stimulation and providing social support and encouragement. Each session is as follows: 1) Child observation & knowledge sharing about child development; 2) Practice of reciprocal attention focusing and social interaction activities; 3) Parent encouragement on behavior and developmental interactions; and 4) Parent social support through referral assistance, reassurance, and validation of parent's concerns.
干预措施: CASITA (Other)
结局指标
主要结局
Change in risk of delay, as measured by the EASQ
时间窗: baseline, 3 months
The Ages and Stages Questionnaire (ASQ) is an internationally-validated instrument that can be used to assess change in developmental risk over time. Fernald et al incorporated additional observation-based assessments and the following modifications: 1) addition of child observation exercises to allow for validity check of parent responses (original ASQ questions), and 2) the incorporation of ASQ questions from the next highest age range. The Extended Ages and Stages Questionnaire (EASQ) was utilized as an assessment tool to allow us to better quantify degree of risk at baseline (based on quintiles of scores). By incorporating ASQ questions from the next two highest age ranges, scores will be continuous across the study period of three. The EASQ has been applied to children in four countries, including 2,845 children in Peru.
次要结局
- Change in global HOME score(baseline, 3 months)
- Change in HOME subscore of parent responsivity(baseline, 3 months)
- Change in HOME subscore of parent involvement(baseline, 3 months)
研究者
Adrianne Katrina Hart Nelson
Research Manager
Brigham and Women's Hospital