WASH Benefits Child Development Follow up (WASH-BFU)
Primary Purpose
Child Development, Maternal Depression
Status
Recruiting
Phase
Not Applicable
Locations
Bangladesh
Study Type
Interventional
Intervention
Water quality
Sanitation
Hand washing
Water quality, Sanitation, Hand washing (Combined WASH)
Nutrition
Nutrition, Water quality, Sanitation, Hand washing
Sponsored by
About this trial
This is an interventional prevention trial for Child Development focused on measuring Child Development, WASH, Nutrition
Eligibility Criteria
Inclusion Criteria:
- Enrolled in the wash-benefits Bangladesh intervention
Exclusion Criteria:
- No Exclusion criteria
Sites / Locations
- International Centre for Diarrhoeal Disease Research, BangladeshRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Active Comparator
No Intervention
Arm Label
Water quality
Sanitation
Hand washing
Combined WASH
Nutrition
Nutrition+ Combined WASH
Non-intervention
Arm Description
90 clusters, approx. 720 newborns
90 clusters, approx. 720 newborns
90 clusters, approx. 720 newborns
90 clusters, approx. 720 newborns
90 clusters, approx. 720 newborns
90 clusters, approx. 720 newborns
180 clusters, approx. 1,440 newborns
Outcomes
Primary Outcome Measures
Weschler Primary and Preschool Scales of Development 4th edition (WPPSI-IV)
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
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
Maternal-report questionnaire designed to measure psychological adjustment in children and aims to detect any emotional or behavioural problems.
Fine Motor Development
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
The Wide Range Assessment Test (WRAT) assessment is a written and verbal assessment of reading, writing, and math achievement.
Secondary Outcome Measures
Maternal Mental Health
Center for Epidemiologic Studies Depression Scale (20 questions). This scale contains 20 questions asking about the number of days in the past week the respondent has experienced each of the symptoms.
Home environment
The middle childhood HOME includes caregiver report and observational items to assess the quality and quantity of stimulation and support available to the child at home.
School attendance
Parental report
Height-for-Age Z-scores
Child's standing height, standardized to Z-scores using the WHO 2006 growth standards
Weight-for-Height Z-scores
Child's weight and height, standardized to Weight-for-Height Z-scores using the WHO 2006 growth standards
Full Information
NCT ID
NCT04443855
First Posted
April 30, 2020
Last Updated
March 29, 2022
Sponsor
International Centre for Diarrhoeal Disease Research, Bangladesh
Collaborators
Stanford University, University of California, Berkeley
1. Study Identification
Unique Protocol Identification Number
NCT04443855
Brief Title
WASH Benefits Child Development Follow up
Acronym
WASH-BFU
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
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 24, 2019 (Actual)
Primary Completion Date
June 30, 2022 (Anticipated)
Study Completion Date
June 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
International Centre for Diarrhoeal Disease Research, Bangladesh
Collaborators
Stanford University, University of California, Berkeley
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Child Development, Maternal Depression
Keywords
Child Development, WASH, Nutrition
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Masking Description
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.
Allocation
Randomized
Enrollment
4932 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Water quality
Arm Type
Active Comparator
Arm Description
90 clusters, approx. 720 newborns
Arm Title
Sanitation
Arm Type
Active Comparator
Arm Description
90 clusters, approx. 720 newborns
Arm Title
Hand washing
Arm Type
Active Comparator
Arm Description
90 clusters, approx. 720 newborns
Arm Title
Combined WASH
Arm Type
Active Comparator
Arm Description
90 clusters, approx. 720 newborns
Arm Title
Nutrition
Arm Type
Active Comparator
Arm Description
90 clusters, approx. 720 newborns
Arm Title
Nutrition+ Combined WASH
Arm Type
Active Comparator
Arm Description
90 clusters, approx. 720 newborns
Arm Title
Non-intervention
Arm Type
No Intervention
Arm Description
180 clusters, approx. 1,440 newborns
Intervention Type
Behavioral
Intervention Name(s)
Water quality
Intervention Description
Hardware: Free supplies chlorine tablets (Aquatabs; NaDCC) and a safe storage vessel to treat and store drinking water.
Promotion: Local promoters will visit study compounds at least monthly to deliver behavior change messages that focus on the treatment of all drinking water for children < 36 months of age.
Intervention Type
Behavioral
Intervention Name(s)
Sanitation
Intervention Description
Hardware: Free child potties, sani-scoop hoes to remove feces from household environments, latrine upgrades to a dual pit latrine Promotion: Local promoters will visit study compounds at least monthly to deliver behavior change messages that focus on the use of latrines for defecation and the removal of human and animal feces from the compound.
Intervention Type
Behavioral
Intervention Name(s)
Hand washing
Intervention Description
Hardware: Hand washing stations, soapy water bottles located at hand washing locations, detergent soap to supply soapy water bottles.
Promotion: Local promoters will visit study compounds at least monthly to deliver behavior change messages that focus on hand washing with soap at critical times around food preparation, defecation, and contact with feces.
Intervention Type
Behavioral
Intervention Name(s)
Water quality, Sanitation, Hand washing (Combined WASH)
Intervention Description
Hardware: Free supplies Aquatabs; (NaDCC) and a safe storage vessel to treat and store drinking water. Promotion: Local promoters will visit study compounds at least monthly to deliver behavior change messages that focus on the treatment of drinking water for children < 36 months.
Hardware: Free child potties, sani-scoop hoes to remove feces from household environments, latrine upgrades to a dual pit latrine. Promotion: Local promoters will visit study compounds at least monthly to deliver behavior change messages that focus on the use of latrines for defecation and the removal of human and animal feces from the compound.
Hardware: Hand washing stations, soapy water bottles, detergent soap to supply soapy water bottles. Promotion: Local promoters will visit study compounds at least monthly to deliver behavior change messages that focus on hand washing with soap at critical times as food preparation, defecation, and contact with feces.
Intervention Type
Behavioral
Intervention Name(s)
Nutrition
Intervention Description
Supplement: Lipid-based Nutrient Supplement (LNS) delivered daily from ages 6 to 24 months.
Promotion: Local promoters will visit study compounds at least monthly to deliver behavior change messages modeled on those recommended in the Guiding Principles for Complementary Feeding of the Breastfed Child and the recent UNICEF Program Guide for Infant and Young Child Feeding Practices.General messages will include (1) practice exclusive breastfeeding from birth to 6 months of age and introduce complementary foods at 6 months of age while continuing to breastfeed; (2) continue breast feeding as you did before receiving LNS; (3) provide your child micronutrient-rich foods such as meat, fish, eggs, and vitamin A rich fruits and vegetables; and (4) feed your child at least 2-3 times per day when 6-8 months old and 3-4 times per day when 9-24 months old.
Intervention Type
Behavioral
Intervention Name(s)
Nutrition, Water quality, Sanitation, Hand washing
Intervention Description
Each of the interventions described above for Water Quality, Sanitation & Hand washing (Combined WASH) Plus the intervention described above for nutrition.
Primary Outcome Measure Information:
Title
Weschler Primary and Preschool Scales of Development 4th edition (WPPSI-IV)
Description
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.
Time Frame
5 years after intervention completion
Title
Executive Functioning
Description
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.
Time Frame
5 years after intervention completion
Title
Child Socioemotional Development
Description
Maternal-report questionnaire designed to measure psychological adjustment in children and aims to detect any emotional or behavioural problems.
Time Frame
5 years after intervention completion
Title
Fine Motor Development
Description
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.
Time Frame
5 years after intervention completion
Title
Academic achievement
Description
The Wide Range Assessment Test (WRAT) assessment is a written and verbal assessment of reading, writing, and math achievement.
Time Frame
5 years after intervention completion
Secondary Outcome Measure Information:
Title
Maternal Mental Health
Description
Center for Epidemiologic Studies Depression Scale (20 questions). This scale contains 20 questions asking about the number of days in the past week the respondent has experienced each of the symptoms.
Time Frame
5 years after intervention completion
Title
Home environment
Description
The middle childhood HOME includes caregiver report and observational items to assess the quality and quantity of stimulation and support available to the child at home.
Time Frame
5 years after intervention completion
Title
School attendance
Description
Parental report
Time Frame
5 years after intervention completion
Title
Height-for-Age Z-scores
Description
Child's standing height, standardized to Z-scores using the WHO 2006 growth standards
Time Frame
5 years after intervention completion
Title
Weight-for-Height Z-scores
Description
Child's weight and height, standardized to Weight-for-Height Z-scores using the WHO 2006 growth standards
Time Frame
5 years after intervention completion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Enrolled in the wash-benefits Bangladesh intervention
Exclusion Criteria:
No Exclusion criteria
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mahbubur Rahman, MD
Phone
+880-2-9827001-10
Ext
4003
Email
mahbubr@icddrb.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mahbubur Rahman, MD
Organizational Affiliation
International Centre for Diarrhoeal Disease Research, Bangladesh
Official's Role
Principal Investigator
Facility Information:
Facility Name
International Centre for Diarrhoeal Disease Research, Bangladesh
City
Dhaka
ZIP/Postal Code
1212
Country
Bangladesh
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mahbubur Rahman, MD
Phone
+880-2-9827001-10
Ext
4003
Email
mahbubr@icddrb.org
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
We will follow as per icddr,b data sharing policy
Learn more about this trial
WASH Benefits Child Development Follow up
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