Caregiver Early Child Development Training for Preventing Konzo From Toxic Cassava in the Democratic Republic of Congo (DRC)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 238
- 试验地点
- 2
- 主要终点
- Mullen Scales of Early Learning (MSEL) Composite Score
研究概览
简要总结
The proposed research adapted the caregiver training and child neurodevelopmental assessment capacity that the PI previously built in Uganda beginning in 2008, to a community-based intervention model for the prevention of konzo in the Democratic Republic of Congo.
详细描述
Early childhood (1 through 4 yrs) is a period of dramatic developmental change that can be seriously compromised by exposure to toxic cyanogenic cassava (konzo disease), with potentially great impact throughout central and western sub-Sahara Africa in regions dependent on this food staple. In the face of ongoing economic instability and nutritional, medical and educational deprivation affecting konzo at-risk communities in the Democratic Republic of Congo, no programs exist for sustaining a favorable developmental milieu for these children. By establishing the viability of caregiver training interventions to enhance functionality among caregivers and improve caregiving quality while preventing konzo, this research l can benefit tens of millions of children at-risk neurodevelopmentally; not only from poorly processed cyanogenic cassava, but also from a myriad of other non-infectious and infectious diseases.
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)
入排标准
- 年龄范围
- 1 Year 至 4 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Mother with at least one child aged between 1 and 4 years
- •Mother is the primary caregiver of child
- •Mother is 18 years of age or older
排除标准
- •History of brain injury (infectious, traumatic, birth) in child
- •Konzo disease in any family member of household
- •Epilepsy in child
- •Any neurodisability in child
- •Caregiver is unable to participate in the year-long training
结局指标
主要结局
Mullen Scales of Early Learning (MSEL) Composite Score
时间窗: Month 6, month 12
The Mullen Scales of Early Learning (MSEL) assesses child developmental domains: visual reception, gross motor skills, fine motor skills, receptive language, and expressive language. A composite t-score derived from standardized t-scores of the four domains (excluding gross motor) provides a measure of g, the general measure of fluid intelligence thought to underlie general cognitive ability. The composite t-score ranges from 40 to 130. The t-scores have mean 100 and standard deviation 15 in the Western population. Higher scores reflect better outcome. Measure is applicable to children only, not collected from caregivers
Child Urine Thiocyanite Level
时间窗: Month 6, month 12
Technicians collected samples of urine on the same day as child assessments, so that they are contiguous with level of cyanide exposure from current poorly processed cassava. Urine thiocyanite levels in urine were measured in micromol per liter. The range was 0-1032, higher scores reflect worse outcome. Data collected from children only, not collected from caregivers.
次要结局
- Home Observation for the Measurement of the Environment (HOME) Score(Month 6, month 12)
- Child Physical Growth: Length for Age Z-score(Month 6, month 12)
- Caregiver Anxiety Symptoms(Month 6, month 12)
- Caregiver Depressive Symptoms(Month 6, month 12)
- Child Physical Growth: Weight for Age Z-score(Month 6, month 12)
研究者
Michael J. Boivin
Professor and Director, Psychiatry Department Research Program
Michigan State University