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Clinical Trials/NCT04443855
NCT04443855
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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 site in 1 country4,932 target enrollmentSeptember 24, 2019

Overview

Phase
N/A
Intervention
Not specified
Conditions
Child Development
Sponsor
International Centre for Diarrhoeal Disease Research, Bangladesh
Enrollment
4932
Locations
1
Primary Endpoint
Weschler Primary and Preschool Scales of Development 4th edition (WPPSI-IV)
Last Updated
4 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
September 24, 2019
End Date
June 30, 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Enrolled in the wash-benefits Bangladesh intervention

Exclusion Criteria

  • No Exclusion criteria

Outcomes

Primary Outcomes

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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 5 years after intervention completion

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

Secondary Outcomes

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

Study Sites (1)

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