Caregiver Interventions for Developmental Delays in Young Kenyan Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Change in Bayley Scales of Infant and Toddler Development, 3rd edition (BSID-III) scores
研究概览
简要总结
In this study, the investigators will only administer the intervention to children known to have neurodevelopmental delays. By focusing on adapting the intervention to be only a clinic-based treatment, a small number of community members could be trained to administer the program and increase the potential for sustainability. If the clinic-based group sessions prove to be effective for young children with neurodevelopmental delays, this would help inform the key areas of fidelity needed to maintain effectiveness of the intervention. This study is a critical first step to evaluating the Care for Child Development Intervention (CCDI) program's potential as a cross-cultural intervention that is sustainable and effective for the children at highest risk for neurodevelopmental delay. These results will have significant impacts in improving early childhood neurodevelopment both in Kenya and worldwide.
详细描述
Objectives:
The broad objective of this proposal is to pilot the CCDI program as an intervention to treat neurodevelopmental delays among 56 young children in Kenya
Specific Aims:
Aim 1: Determine the feasibility of a randomized controlled trial protocol to examine the effectiveness of the CCDI Program for Kenyan children with neurodevelopmental delays aged 18-24 months within a public Maternal-Child Health (MCH) clinic setting.
Hypothesis: The CCDI Program will be feasible, as measured by ≥90% of participants being willing to be randomized to either the intervention or the control group; ≥ 80% attending all 10 biweekly caregiver meetings; ≥80% of children returning for their 6 month follow-up; and ≥80% returning for 12 month follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Months 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age 18-24 months
- •communicate in either English or Kiswahili
- •Score < 85 on one of the BSID-III subscales (mild/moderate/severe delay in cognitive, motor, or language).
- •Have a caregiver who can communicate in English or Kiswahili
- •Have a caregiver responsible for child's daily activities
排除标准
- •Profound neurological impairment, such as severe cerebral palsy, deafness, or blindness preventing them from participating in the groups.
结局指标
主要结局
Change in Bayley Scales of Infant and Toddler Development, 3rd edition (BSID-III) scores
时间窗: Baseline, 6 months, 12 months
Measures cognitive, language, and motor development. Composite scores for cognitive (range of scores 55-145), language (range of scores 47-153), and motor (range of scores 46-154) development. Lower scores indicate worse development. Subscales (e.g. fine and gross motor for motor and expressive and receptive language for language) are summed to create the composite score.
次要结局
- Change in MacArthur-Bates Communication Developmental Inventory (CDI) scores(Baseline, 6 months, 12 months)
- Change in Home Observations Measurement of the Environment (HOME) scores(Baseline, 6 months, 12 months)
- Change in mother interactions, gathered by video-taped mother interactions(6 months and 12 months)
- Change In Perspectives around Child Development, gathered by Focus Group Discussions(6 months and 12 months)
研究者
Megan Song McHenry
Assistant Professor of Pediatrics
Indiana University