Clinical trial NCT04443855: WASH Benefits Child Development Follow up
Official title: Measuring the Effect of WASH Benefits Interventions on Child Development Outcomes at School Age: Follow up of an Efficacy Trial in Rural Bangladesh
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Child Development
Maternal Depression
Keywords: Child Development
WASH
Nutrition
Lead sponsor: International Centre for Diarrhoeal Disease Research, Bangladesh
Sponsor class: OTHER
Collaborators: name: Stanford University
name: University of California, Berkeley
First posted: 2020-06-23
Enrollment: 4932
Sex: ALL
Minimum age (years): 5
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* Enrolled in the wash-benefits Bangladesh intervention

Exclusion Criteria:

* No Exclusion criteria

Primary outcomes:
measure: Weschler Primary and Preschool Scales of Development 4th edition (WPPSI-IV)
timeFrame: 5 years after intervention completion
measure: Executive Functioning
timeFrame: 5 years after intervention completion
measure: Child Socioemotional Development
timeFrame: 5 years after intervention completion
measure: Fine Motor Development
timeFrame: 5 years after intervention completion
measure: Academic achievement
timeFrame: 5 years after intervention completion
Secondary outcomes:
measure: Maternal Mental Health
timeFrame: 5 years after intervention completion
measure: Home environment
timeFrame: 5 years after intervention completion
measure: School attendance
timeFrame: 5 years after intervention completion
measure: Height-for-Age Z-scores
timeFrame: 5 years after intervention completion
measure: Weight-for-Height Z-scores
timeFrame: 5 years after intervention completion
Other outcomes:
Locations:
city: Dhaka
country: Bangladesh
facility: International Centre for Diarrhoeal Disease Research, Bangladesh
Study officials:
affiliation: International Centre for Diarrhoeal Disease Research, Bangladesh
name: Mahbubur Rahman, MD
role: PRINCIPAL_INVESTIGATOR
References: