<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04443855</url>
  </required_header>
  <id_info>
    <org_study_id>PR-19025</org_study_id>
    <nct_id>NCT04443855</nct_id>
  </id_info>
  <brief_title>WASH Benefits Child Development Follow up</brief_title>
  <acronym>WASH-BFU</acronym>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>International Centre for Diarrhoeal Disease Research, Bangladesh</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Stanford University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of California, Berkeley</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>International Centre for Diarrhoeal Disease Research, Bangladesh</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine if the effects of individual and combined water,&#xD;
      sanitation, hygiene, and nutrition interventions in early childhood on child development and&#xD;
      maternal mental health persist into middle childhood. This study is a follow-up assessment of&#xD;
      the children and mothers enrolled in the WASH-Benefits Bangladesh study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Globally, millions of children experience delays in physical health and cognitive&#xD;
      development, due to their exposures to poverty and related issues. In low-and middle-income&#xD;
      countries, children experience a dis-proportionally high burden of exposure to poverty and&#xD;
      related risk factors for delayed development including of poor health and nutrition,&#xD;
      inadequate responsive care giving, and a lack of opportunities for early learning. Water,&#xD;
      sanitation and hygiene (WASH) interventions have the potential to positively affect the&#xD;
      developmental trajectories of children by reducing enteric pathogen infection, improving&#xD;
      child health, and altering parental care practices. A recent cluster-randomized controlled&#xD;
      trial (cRCT) in Bangladesh (WASH-Benefits, or WASH-B, Clinical Trials.gov Identifier:&#xD;
      NCT01590095), found that improvements in WASH or nutrition supported by intensive&#xD;
      interpersonal communication, when delivered either individually or in combination,&#xD;
      contributed to improvements in child development outcomes at 1 and 2 years of age, and&#xD;
      mothers in all intervention groups reported lower depressive symptoms than mothers in the&#xD;
      control households.&#xD;
&#xD;
      This follow-up study, funded by the Bill &amp; Melinda Gates foundation, includes assessments of&#xD;
      the children and caregivers originally enrolled in the WASH Benefits intervention 5 years&#xD;
      following intervention completion, when the children are 5-8 year of age. The original WASH&#xD;
      Benefits intervention enrolled pregnant women between May 31, 2012, and July 7, 2013. The&#xD;
      goal of this follow-up study is to examine whether the improvements in child development and&#xD;
      maternal mental health are sustained when the children are in middle childhood. Our guiding&#xD;
      hypothesis is that interventions that showed early impact will continue to improve child and&#xD;
      maternal outcomes at this follow-up time period. Investigators will attempt to collect&#xD;
      follow-up data from every household originally randomized to one of the 7 arms in the WASH&#xD;
      Benefits trial.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 24, 2019</start_date>
  <completion_date type="Anticipated">June 30, 2022</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Investigator)</masking>
    <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.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Weschler Primary and Preschool Scales of Development 4th edition (WPPSI-IV)</measure>
    <time_frame>5 years after intervention completion</time_frame>
    <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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Executive Functioning</measure>
    <time_frame>5 years after intervention completion</time_frame>
    <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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Child Socioemotional Development</measure>
    <time_frame>5 years after intervention completion</time_frame>
    <description>Maternal-report questionnaire designed to measure psychological adjustment in children and aims to detect any emotional or behavioural problems.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fine Motor Development</measure>
    <time_frame>5 years after intervention completion</time_frame>
    <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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Academic achievement</measure>
    <time_frame>5 years after intervention completion</time_frame>
    <description>The Wide Range Assessment Test (WRAT) assessment is a written and verbal assessment of reading, writing, and math achievement.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maternal Mental Health</measure>
    <time_frame>5 years after intervention completion</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Home environment</measure>
    <time_frame>5 years after intervention completion</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>School attendance</measure>
    <time_frame>5 years after intervention completion</time_frame>
    <description>Parental report</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Height-for-Age Z-scores</measure>
    <time_frame>5 years after intervention completion</time_frame>
    <description>Child's standing height, standardized to Z-scores using the WHO 2006 growth standards</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Weight-for-Height Z-scores</measure>
    <time_frame>5 years after intervention completion</time_frame>
    <description>Child's weight and height, standardized to Weight-for-Height Z-scores using the WHO 2006 growth standards</description>
  </secondary_outcome>
  <number_of_arms>7</number_of_arms>
  <enrollment type="Anticipated">4932</enrollment>
  <condition>Child Development</condition>
  <condition>Maternal Depression</condition>
  <arm_group>
    <arm_group_label>Water quality</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>90 clusters, approx. 720 newborns</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sanitation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>90 clusters, approx. 720 newborns</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hand washing</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>90 clusters, approx. 720 newborns</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Combined WASH</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>90 clusters, approx. 720 newborns</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Nutrition</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>90 clusters, approx. 720 newborns</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Nutrition+ Combined WASH</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>90 clusters, approx. 720 newborns</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-intervention</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>180 clusters, approx. 1,440 newborns</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Water quality</intervention_name>
    <description>Hardware: Free supplies chlorine tablets (Aquatabs; NaDCC) and a safe storage vessel to treat and store drinking water.&#xD;
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 &lt; 36 months of age.</description>
    <arm_group_label>Water quality</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Sanitation</intervention_name>
    <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.</description>
    <arm_group_label>Sanitation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Hand washing</intervention_name>
    <description>Hardware: Hand washing stations, soapy water bottles located at hand washing locations, detergent soap to supply soapy water bottles.&#xD;
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.</description>
    <arm_group_label>Hand washing</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Water quality, Sanitation, Hand washing (Combined WASH)</intervention_name>
    <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 &lt; 36 months.&#xD;
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.&#xD;
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.</description>
    <arm_group_label>Combined WASH</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Nutrition</intervention_name>
    <description>Supplement: Lipid-based Nutrient Supplement (LNS) delivered daily from ages 6 to 24 months.&#xD;
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.</description>
    <arm_group_label>Nutrition</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Nutrition, Water quality, Sanitation, Hand washing</intervention_name>
    <description>Each of the interventions described above for Water Quality, Sanitation &amp; Hand washing (Combined WASH) Plus the intervention described above for nutrition.</description>
    <arm_group_label>Nutrition+ Combined WASH</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Enrolled in the wash-benefits Bangladesh intervention&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No Exclusion criteria&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>7 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mahbubur Rahman, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>International Centre for Diarrhoeal Disease Research, Bangladesh</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Mahbubur Rahman, MD</last_name>
    <phone>+880-2-9827001-10</phone>
    <phone_ext>4003</phone_ext>
    <email>mahbubr@icddrb.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>International Centre for Diarrhoeal Disease Research, Bangladesh</name>
      <address>
        <city>Dhaka</city>
        <zip>1212</zip>
        <country>Bangladesh</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mahbubur Rahman, MD</last_name>
      <phone>+880-2-9827001-10</phone>
      <phone_ext>4003</phone_ext>
      <email>mahbubr@icddrb.org</email>
    </contact>
  </location>
  <location_countries>
    <country>Bangladesh</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>April 30, 2020</study_first_submitted>
  <study_first_submitted_qc>June 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 23, 2020</study_first_posted>
  <last_update_submitted>March 29, 2022</last_update_submitted>
  <last_update_submitted_qc>March 29, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 31, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Child Development</keyword>
  <keyword>WASH</keyword>
  <keyword>Nutrition</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>We will follow as per icddr,b data sharing policy</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04443855
org study id: PR-19025
nct id: NCT04443855
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (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.
measure: Weschler Primary and Preschool Scales of Development 4th edition (WPPSI-IV)
time frame: 5 years after intervention completion
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.
measure: Executive Functioning
time frame: 5 years after intervention completion
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.
measure: Child Socioemotional Development
time frame: 5 years after intervention completion
description: Maternal-report questionnaire designed to measure psychological adjustment in children and aims to detect any emotional or behavioural problems.
measure: Fine Motor Development
time frame: 5 years after intervention completion
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.
measure: Academic achievement
time frame: 5 years after intervention completion
description: The Wide Range Assessment Test (WRAT) assessment is a written and verbal assessment of reading, writing, and math achievement.
measure: Maternal Mental Health
time frame: 5 years after intervention completion
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.
measure: Home environment
time frame: 5 years after intervention completion
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.
measure: School attendance
time frame: 5 years after intervention completion
description: Parental report
measure: Height-for-Age Z-scores
time frame: 5 years after intervention completion
description: Child's standing height, standardized to Z-scores using the WHO 2006 growth standards
measure: Weight-for-Height Z-scores
time frame: 5 years after intervention completion
description: Child's weight and height, standardized to Weight-for-Height Z-scores using the WHO 2006 growth standards
arm group label: Water quality
arm group type: Active Comparator
description: 90 clusters, approx. 720 newborns
arm group label: Sanitation
arm group type: Active Comparator
description: 90 clusters, approx. 720 newborns
arm group label: Hand washing
arm group type: Active Comparator
description: 90 clusters, approx. 720 newborns
arm group label: Combined WASH
arm group type: Active Comparator
description: 90 clusters, approx. 720 newborns
arm group label: Nutrition
arm group type: Active Comparator
description: 90 clusters, approx. 720 newborns
arm group label: Nutrition+ Combined WASH
arm group type: Active Comparator
description: 90 clusters, approx. 720 newborns
arm group label: Non-intervention
arm group type: No Intervention
description: 180 clusters, approx. 1,440 newborns
intervention type: Behavioral
intervention name: Water quality
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.
arm group label: Water quality
intervention type: Behavioral
intervention name: Sanitation
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.
arm group label: Sanitation
intervention type: Behavioral
intervention name: Hand washing
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.
arm group label: Hand washing
intervention type: Behavioral
intervention name: Water quality, Sanitation, Hand washing (Combined WASH)
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.
arm group label: Combined WASH
intervention type: Behavioral
intervention name: Nutrition
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.
arm group label: Nutrition
intervention type: Behavioral
intervention name: Nutrition, Water quality, Sanitation, Hand washing
description: Each of the interventions described above for Water Quality, Sanitation & Hand washing (Combined WASH) Plus the intervention described above for nutrition.
arm group label: Nutrition+ Combined WASH
criteria: 
gender: All
minimum age: 5 Years
maximum age: 7 Years
healthy volunteers: No
last name: Mahbubur Rahman, MD
role: Principal Investigator
affiliation: International Centre for Diarrhoeal Disease Research, Bangladesh
last name: Mahbubur Rahman, MD
phone: +880-2-9827001-10
phone ext: 4003
email: mahbubr@icddrb.org
facility: 
status: Recruiting
contact: 
country: Bangladesh
responsible party type: Sponsor
mesh term: Depression
sharing ipd: No
ipd description: We will follow as per icddr,b data sharing policy