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临床试验/NCT04443855
NCT04443855Unknown不适用

Measuring the Effect of WASH Benefits Interventions on Child Development Outcomes at School Age: Follow up of an Efficacy Trial in Rural Bangladesh

International Centre for Diarrhoeal Disease Research, Bangladesh1 个研究点 分布在 1 个国家目标入组 4,932 人开始时间: 2019年9月24日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
4,932
试验地点
1
主要终点
Weschler Primary and Preschool Scales of Development 4th edition (WPPSI-IV)

研究概览

简要总结

The purpose of this study is to determine if the effects of individual and combined water, sanitation, hygiene, and nutrition interventions in early childhood on child development and maternal mental health persist into middle childhood. This study is a follow-up assessment of the children and mothers enrolled in the WASH-Benefits Bangladesh study.

详细描述

Globally, millions of children experience delays in physical health and cognitive development, due to their exposures to poverty and related issues. In low-and middle-income countries, children experience a dis-proportionally high burden of exposure to poverty and related risk factors for delayed development including of poor health and nutrition, inadequate responsive care giving, and a lack of opportunities for early learning. Water, sanitation and hygiene (WASH) interventions have the potential to positively affect the developmental trajectories of children by reducing enteric pathogen infection, improving child health, and altering parental care practices. A recent cluster-randomized controlled trial (cRCT) in Bangladesh (WASH-Benefits, or WASH-B, Clinical Trials.gov Identifier: NCT01590095), found that improvements in WASH or nutrition supported by intensive interpersonal communication, when delivered either individually or in combination, contributed to improvements in child development outcomes at 1 and 2 years of age, and mothers in all intervention groups reported lower depressive symptoms than mothers in the control households.

This follow-up study, funded by the Bill & Melinda Gates foundation, includes assessments of the children and caregivers originally enrolled in the WASH Benefits intervention 5 years following intervention completion, when the children are 5-8 year of age. The original WASH Benefits intervention enrolled pregnant women between May 31, 2012, and July 7, 2013. The goal of this follow-up study is to examine whether the improvements in child development and maternal mental health are sustained when the children are in middle childhood. Our guiding hypothesis is that interventions that showed early impact will continue to improve child and maternal outcomes at this follow-up time period. Investigators will attempt to collect follow-up data from every household originally randomized to one of the 7 arms in the WASH Benefits trial.

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 (Investigator)

盲法说明

The outcome assessment team is separate from the implementation team, however due to the nature of the interventions there may be intervention contents visible during the assessment. Data analysis will be masked to randomization status of clusters.

入排标准

年龄范围
5 Years 至 7 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Enrolled in the wash-benefits Bangladesh intervention

排除标准

  • •No Exclusion criteria

研究组 & 干预措施

Water quality

Active Comparator

90 clusters, approx. 720 newborns

干预措施: Water quality (Behavioral)

Sanitation

Active Comparator

90 clusters, approx. 720 newborns

干预措施: Sanitation (Behavioral)

Hand washing

Active Comparator

90 clusters, approx. 720 newborns

干预措施: Hand washing (Behavioral)

Combined WASH

Active Comparator

90 clusters, approx. 720 newborns

干预措施: Water quality, Sanitation, Hand washing (Combined WASH) (Behavioral)

Nutrition

Active Comparator

90 clusters, approx. 720 newborns

干预措施: Nutrition (Behavioral)

Nutrition+ Combined WASH

Active Comparator

90 clusters, approx. 720 newborns

干预措施: Nutrition, Water quality, Sanitation, Hand washing (Behavioral)

Non-intervention

No Intervention

180 clusters, approx. 1,440 newborns

结局指标

主要结局

Weschler Primary and Preschool Scales of Development 4th edition (WPPSI-IV)

时间窗: 5 years after intervention completion

The WPPSI-IV assessment measures cognitive development and general intellectual abilities in children 2 years 6 months to 7 years 7 months of age (2:6-7:7), and includes assessments of both performance and verbal skills.

Executive Functioning

时间窗: 5 years after intervention completion

This executive functioning assessment consists of three sub-scales to assess executive functioning in children including verbal memory, visual and non-verbal memory, and memory capacity.

Child Socioemotional Development

时间窗: 5 years after intervention completion

Maternal-report questionnaire designed to measure psychological adjustment in children and aims to detect any emotional or behavioural problems.

Fine Motor Development

时间窗: 5 years after intervention completion

Manual Dexterity component of Movement Assessment Battery for Children-2 (MABC-2) is a direct assessment tool used to measure fine motor skills in children 3 to 17 years of age.

Academic achievement

时间窗: 5 years after intervention completion

The Wide Range Assessment Test (WRAT) assessment is a written and verbal assessment of reading, writing, and math achievement.

次要结局

  • Height-for-Age Z-scores(5 years after intervention completion)
  • Maternal Mental Health(5 years after intervention completion)
  • Home environment(5 years after intervention completion)
  • School attendance(5 years after intervention completion)
  • Weight-for-Height Z-scores(5 years after intervention completion)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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