<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/NCT03753646</url>
  </required_header>
  <id_info>
    <org_study_id>PR-18035</org_study_id>
    <nct_id>NCT03753646</nct_id>
  </id_info>
  <brief_title>Evaluating Effects of Integrating ECD Activities Into Bangladesh Government's Urban Lactating Mothers Allowance Program for the Poor on Children's Cognition and Behavior in Rangpur City Corporation, Bangladesh</brief_title>
  <official_title>Evaluating Effects of Integrating ECD Activities Into Bangladesh Government's Urban Lactating Mothers Allowance Program for the Poor on Children's Cognition and Behaviour in Rangpur City Corporation, Bangladesh</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>International Centre for Diarrhoeal Disease Research, Bangladesh</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </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>
      Burden:&#xD;
&#xD;
      Provision of health care to urban poor population is a great challenge because of supply and&#xD;
      demand barriers in the urban health system, which is considered patchy and fragmented. The&#xD;
      poor urban people, especially mothers have little access to government health facilities. The&#xD;
      health care platform is not well designed in primary health care delivery for urban health&#xD;
      system but presently almost 30 percent people are living in urban area of the country.&#xD;
&#xD;
      Knowledge gap:&#xD;
&#xD;
      Little is known about what happen if psycho social stimulation is provided using urban&#xD;
      lactating allowance program on children's cognition and behavior. There is little information&#xD;
      about nature and bottleneck of Early Childhood Development (ECD) activities available in the&#xD;
      urban Bangladesh.&#xD;
&#xD;
      Relevance:&#xD;
&#xD;
      This is an opportunity to develop a combined package integrating psycho social stimulation&#xD;
      with the existing urban lactating allowance program on disadvantaged children's development.&#xD;
&#xD;
      As the urban health system is complex, patchy and fragmented, prior to this intervention An&#xD;
      analysis will be done on ECD services and its bottleneck in urban area through Tanahashi&#xD;
      framework.&#xD;
&#xD;
      Hypothesis (if any):&#xD;
&#xD;
      Adding psycho social stimulation to urban lactating allowance program will have additional&#xD;
      effect on children's cognitive, motor and language development and behavior compared to the&#xD;
      comparison group&#xD;
&#xD;
      Secondary Hypothesis:&#xD;
&#xD;
      Additionally the intervention will- improve mothers' quality of life and reduce their&#xD;
      depressive symptoms be cost effective,&#xD;
&#xD;
      Objectives:&#xD;
&#xD;
        -  To evaluate the effect of integrated urban lactating allowance and psycho social&#xD;
           stimulation on children's cognitive, motor and language development and behavior&#xD;
&#xD;
        -  To measure nature and bottleneck of ECD services in urban Bangladesh&#xD;
&#xD;
      Secondary objectives:&#xD;
&#xD;
      To measure effect of the programs on:&#xD;
&#xD;
        -  mothers' quality of life and mental health (depression symptoms)&#xD;
&#xD;
        -  cost effectiveness of the intervention&#xD;
&#xD;
      Methods: A two-arm, Cluster Randomized Controlled Trial: i) Lactating allowance + Psycho&#xD;
      social stimulation; (ii) Only lactating allowance&#xD;
&#xD;
      Outcome measures/variables: Children's cognitive, motor and language development measured on&#xD;
      Bayley-III, behavior on Wolke's rating scales, Mother's quality of life and depressive&#xD;
      symptoms , household food security status, socioeconomic status, quality of home stimulation&#xD;
      using family care indicators, Mother's knowledge on child care and development, children's&#xD;
      growth measured by length/height, weight and head circumference,mothers' height, weight and&#xD;
      mid upper arm circumference, direct and indirect cost of the project.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      It is estimated that 250 million children do not reach their potential due to poverty,&#xD;
      inadequate stimulation and associated risk factors in low and middle income countries.&#xD;
&#xD;
      In Bangladesh more than 50% of children under 5 years are at risk of developmental delay.&#xD;
      Urban population is about 28% and it is expected to rise to more than 40% by 2030. In fact,&#xD;
      urbanization in Bangladesh is rapidly growing but is not well planned. Poor urban women and&#xD;
      children are vulnerable in terms of health and education .&#xD;
&#xD;
      The urban health care facilities are fragmented and patchy and every year rise in population&#xD;
      is putting more pressure on health system. Moreover, there is huge economic disparity between&#xD;
      rich and poor in the urban areas and poorer people have little access to health care due to&#xD;
      both supply and demand barriers. So the situation is rolling more difficult every day.&#xD;
&#xD;
      Ministry of Women and Children Affairs (MOWCA) has taken initiatives to help urban poor&#xD;
      mothers through lactating allowance (LA) and limited health education programs. A study&#xD;
      conducted in Zimbabwe documented that unconditional cash transfer showed an increase in&#xD;
      receiving children's birth certificate and immunization in the age group of 0-4years and&#xD;
      school attendance in 6-12 years. Recent systematic review concluded that unconditional cash&#xD;
      transfer may not improve health services use in children and adult in low and middle income&#xD;
      countries but may have positive impact on food choices and food security. It is expected that&#xD;
      this urban lactating allowance will develop economic capacity of people, empower women,&#xD;
      improve their quality of life and reduce gender gap.&#xD;
&#xD;
      Very few ECD programs are available for poor urban children especially for the 1st thousand&#xD;
      days. The idea is to develop a combined package integrating psycho social stimulation with&#xD;
      the existing urban lactating allowance program and measuring its effects on disadvantaged&#xD;
      children's development.&#xD;
&#xD;
      As the urban health system is complex, patchy and fragmented, prior to this intervention an&#xD;
      analysis will be done on ECD services and its bottleneck in the project area through&#xD;
      Tanahashi framework. A facility assessment will be done to understand nature of ECD services.&#xD;
      A meeting will be conducted with relevant experts to finalize the services delivery mechanism&#xD;
      of the intervention.&#xD;
&#xD;
      Research Design and Methods:&#xD;
&#xD;
      This study will follow two sequential stages:&#xD;
&#xD;
      Stage I: Understand nature and analyse bottleneck of ECD services in selected urban areas of&#xD;
      Bangladesh through a survey using Tanahasi framework.&#xD;
&#xD;
      Stage II: Document that adding ECD activities to urban lactating allowance program will&#xD;
      improve children's cognition, motor, language and behaviour.&#xD;
&#xD;
      Methodology for stage I:&#xD;
&#xD;
      First, an analysis will be done on ECD program in urban area through Tanahashi framework. A&#xD;
      documentation will be done on availability, accessibility, utilization and adequate coverage&#xD;
      of the ECD activities.&#xD;
&#xD;
      ECD and related services will be analyzed through:&#xD;
&#xD;
      a) Household Survey and b) Facility assessment&#xD;
&#xD;
        1. Household survey A survey will be conducted with 426 mothers having child less than five&#xD;
           years. On an average 22 respondents will be recruited from each cluster. the total&#xD;
           clusters will be 20.&#xD;
&#xD;
           Sample size was calculated assuming 50% effective coverage, 20% error, 95% confidence&#xD;
           interval and 10% refusal rate the total sample size calculated was 426 in an urban&#xD;
           setting..&#xD;
&#xD;
        2. Facility Assessment Moreover, ECD or relevant services will be collected through&#xD;
           visiting service delivery facilities. government and private hospitals, NGOs and schools&#xD;
           (kindergarten) will be visited and data will be collected on services available.&#xD;
&#xD;
      At the end of this stage, a stakeholders meeting with relevant experts will be conducted to&#xD;
      finalize a service delivery mechanism&#xD;
&#xD;
      Methodology for stage II:&#xD;
&#xD;
      The main aim is to document that adding ECD activities to urban lactating allowance program&#xD;
      improves children's cognition, language and motor and behaviour.&#xD;
&#xD;
      Study design:&#xD;
&#xD;
      This is a cluster randomized controlled trial of the effects of adding psycho social&#xD;
      stimulation to the existing lactating allowance of the country with 2 arms: i) Psycho social&#xD;
      stimulation+ Urban lactating allowance and ii) Only urban lactating allowance.&#xD;
&#xD;
      Selection of the study area:&#xD;
&#xD;
      A municipality will be selected for this study. The Initial plan is to conduct the study in&#xD;
      Rangpur City Corporation.&#xD;
&#xD;
      Recruitment:&#xD;
&#xD;
      There will be 20 clusters (10 interventions &amp; 10 comparisons) and 30 mother child dyads in&#xD;
      each cluster. In Rangpure City Corporation there are 33 Wards. A Ward will be considered as a&#xD;
      cluster. Cluster will be assigned randomly to intervention or comparisions group. A buffer&#xD;
      zone will be made to reduce spill over effect with remaining Wards and or villages.&#xD;
&#xD;
      As the Government is providing urban lactating allowance to 2000 mothers in Rangpur City&#xD;
      Corporation, it is expected that there will be approximately at least 50 mother child dyads&#xD;
      in each cluster. 30 participants will be selected from the list considering mothers lower age&#xD;
      and/or those with single child (if available).&#xD;
&#xD;
      Sample Size:&#xD;
&#xD;
      In total, sample is 600. Previous studies of psycho social stimulation alone achieved an&#xD;
      effect size of 0.4 SD on children's development. In this study, lactating allowance (cash) as&#xD;
      an intervention that might have also positive effect on the child development. But to be on&#xD;
      the safe side, it is assumed that an effect size of 0.35 SD, 80% power, 95% confidence&#xD;
      interval, 1.58 cluster design effect and 25% drop-out rate the sample size was calculated to&#xD;
      be 300 in each arm with 30 children in each of the 20 clusters.&#xD;
&#xD;
      Data Analysis:&#xD;
&#xD;
      Data will be checked for normality. Appropriate measures will be taken if there are any&#xD;
      abnormal distributions. Frequency table and percentage will be used to present nature of ECD&#xD;
      services and its bottleneck. Service availability would be presented in a table through&#xD;
      facility assessment and the bottlenecks (accessibility, utilization and coverage) will also&#xD;
      be presented through interviews with mothers. For intervention trial, differences between&#xD;
      groups in background characteristics will be analyzed using t-test for continuous variables&#xD;
      and chi-square test for categorical variables.. Effect of the ECD intervention will be&#xD;
      measured using intention-to-treat analysis controlling for the clustering effect in&#xD;
      multivariate regression analysis. All covariates will be controlled and effect modifier and&#xD;
      mulnicolinearity will be checked before regression analysis. Quality of life data will be&#xD;
      analysed based on WHO guideline for WHOQoL tools.. Similarly, total score of SRQ will be&#xD;
      calculated and then differences between arms will be analysed.&#xD;
&#xD;
      Cost-effectiveness Analysis:&#xD;
&#xD;
      The objective of the study is to estimate the resource use and costs associated with&#xD;
      interventions. Direct and indirect cost will be measured for all the groups. Average costs&#xD;
      per participants will be calculated by multiplying the cost of resource items by their&#xD;
      respective unit costs. Outcomes will be generated from the study after the intervention and&#xD;
      the differences will be measured before and after the intervention in two groups. Then the&#xD;
      incremental cost-effectiveness ratio (ICER) will be used in cost-effectiveness analysis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 1, 2018</start_date>
  <completion_date type="Anticipated">December 2022</completion_date>
  <primary_completion_date type="Anticipated">December 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>
    <intervention_model_description>We will integrate ECD services to Bangladesh government lactating allowance to measure children's neurocognitive behavior in urban area of Bangladesh.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>The Assessor who will measure children's cognitive development and behavor and other measurements will be masked</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Children's cognitive composite score ranging from 55 to 145 using Bayley Scales of Infant and Toddler Development (Bayley-III)</measure>
    <time_frame>Children's cognitive composite score ranging from 55 to 145 using Bayley Scales of Infant and Toddler Development (Bayley-III) after one year intervention</time_frame>
    <description>Children's cognitive composite score ranging from 55 to 145 using Bayley Scales of Infant and Toddler Development (Bayley-III). Higher values represent a better status</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Children's language composite score ranging from 45 to 155 using Bayley Scales of Infant and Toddler Development (Bayley-III)</measure>
    <time_frame>Children's language composite score ranging from 45 to 155 using Bayley Scales of Infant and Toddler Development (Bayley-III) after one year intervention</time_frame>
    <description>Children's language composite score ranging from 45 to 155 using Bayley Scales of Infant and Toddler Development (Bayley-III). Higher values represent a better status</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Children's motor composite score ranging from 45 to 155 using Bayley Scales of Infant and Toddler Development (Bayley-III)</measure>
    <time_frame>Children's motor composite score ranging from 45 to 155 using Bayley Scales of Infant and Toddler Development (Bayley-III) after one year intervention</time_frame>
    <description>Children's motor composite score ranging from 45 to 155 using Bayley Scales of Infant and Toddler Development (Bayley-III). Higher values represent a better status</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Children's approach behaviour using Wolk's behavior rating scale ranging from 1 to 9</measure>
    <time_frame>Children's approach behaviour using Wolk's behavior rating scale ranging from 1 to 9 after one year intervention</time_frame>
    <description>Children's approach behaviour using Wolk's behavior rating scale ranging from 1 to 9 during Bayley. Higher values represent a better status</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Children's general emotion tone behaviour using Wolk's behavior rating scale ranging from 1 to 9</measure>
    <time_frame>Children's general emotion tone behaviour using Wolk's behavior rating scale ranging from 1 to 9 after one year intervention</time_frame>
    <description>Children's general emotion tone behaviour using Wolk's behavior rating scale ranging from 1 to 9 during Bayley. Higher values represent a better status</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Children's activity behaviour using Wolk's behavior rating scale ranging from 1 to 9</measure>
    <time_frame>Children's activity behaviour using Wolk's behavior rating scale ranging from 1 to 9 after one year intervention</time_frame>
    <description>Children's activity behaviour using Wolk's behavior rating scale ranging from 1 to 9 during Bayley. Higher values represent a more active status.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Children's cooperation behaviour using Wolk's behavior rating scale ranging from 1 to 9</measure>
    <time_frame>Children's cooperation behaviour using Wolk's behavior rating scale ranging from 1 to 9 after one year intervention</time_frame>
    <description>Children's cooperation behaviour using Wolk's behavior rating scale ranging from 1 to 9 during Bayley. Higher values represent a better status</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Children's vocalization behaviour using Wolk's behavior rating scale ranging from 1 to 9</measure>
    <time_frame>Children's vocalization behaviour using Wolk's behavior rating scale ranging from 1 to 9 after one year intervention</time_frame>
    <description>Children's vocalization behaviour using Wolk's behavior rating scale ranging from 1 to 9 during Bayley. Higher values represent a better status</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Children's weight</measure>
    <time_frame>Change children's weight after one year intervention</time_frame>
    <description>Children's weight will be measured in Gram</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Children's height</measure>
    <time_frame>Change children's height after one year intervention</time_frame>
    <description>Children's height will be measured in Gram</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Children's Mid Upper Arm circumference (MUAC)</measure>
    <time_frame>Change children's MUAC after one year intervention</time_frame>
    <description>Children's MUAC will be measured by millimeter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mothers' weight</measure>
    <time_frame>Change mother's weight after one year intervention</time_frame>
    <description>Mothers' weight will be measured in Gram</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mothers' height</measure>
    <time_frame>Change mother's height after one year intervention</time_frame>
    <description>Mothers' height will be measured by Centimeter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mothers' Mid Upper Arm circumference (MUAC)</measure>
    <time_frame>Change mother's Mid Upper Arm circumference (MUAC) after one year intervention</time_frame>
    <description>Mothers' Mid Upper Arm circumference (MUAC) will be measured by Centimeter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mothers' depressive symptom</measure>
    <time_frame>Change mother's depression status after one year intervention</time_frame>
    <description>Mothers' depressive symptom will be measured by Self-Regulation Questionnaire (SRQ). higher values represent a worse mental status</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mothers' quality of life status</measure>
    <time_frame>Change mother's quality of life status after one year intervention</time_frame>
    <description>Mothers' quality of life status will be measured by World Health Organization (WHO) quality of life questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Family's monthly food security status</measure>
    <time_frame>Change family's food security status after one year intervention</time_frame>
    <description>Family's monthly food security status will be measured by Household Food Insecurity Access Scale (HFIAS) questionnaire. The status will be measured as per HFIAS analysis guideline developed by the U.S. Agency for International Development (USAID).&#xD;
Measurement of Food Access:&#xD;
Indicator Guide</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Domestic violence (mothers)</measure>
    <time_frame>Change family's domestic violence status after one year intervention</time_frame>
    <description>Domestic violence (mothers) monthly status will be measured by questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Family care indicators (FCI)</measure>
    <time_frame>Change of FCI after one year intervention</time_frame>
    <description>Family care indicators (FCI) will be measured by questionnaire. Higher values represent a better environment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mothers' knowledge on parenting</measure>
    <time_frame>Change of mothers' knowledge after one year intervention</time_frame>
    <description>Mothers' knowledge on parenting questionnaire will be used</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Family's health seeking behavior</measure>
    <time_frame>Change family's health seeking behaviour status after one year intervention</time_frame>
    <description>Family's health seeking behavior status will be measured by questionnaire</description>
  </other_outcome>
  <other_outcome>
    <measure>Family's income</measure>
    <time_frame>Change family's income status after one year intervention</time_frame>
    <description>Family's monthly income status will be measured by questionnaire</description>
  </other_outcome>
  <other_outcome>
    <measure>Family's expenditure</measure>
    <time_frame>Change family's expenditure status after one year intervention</time_frame>
    <description>Family's expenditure status will be measured by questionnaire</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">600</enrollment>
  <condition>Early Childhood Development</condition>
  <arm_group>
    <arm_group_label>Lactating allowance and psycho social stimulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Mothers will receive lactating allowance and psycho social stimulation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Only lactating allowance</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Mothers will receive only lactating allowance</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Lactating allowance and psycho social stimulation</intervention_name>
    <description>Mothers will receive lactating allowance and psycho social stimulation</description>
    <arm_group_label>Lactating allowance and psycho social stimulation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Mothers with a child aged 6-16 months&#xD;
&#xD;
          -  Not expected to leave the study site for more than 2 months&#xD;
&#xD;
          -  Has a legally acceptable representative capable of understanding the informed consent&#xD;
             document and providing consent on the participant's behalf.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Legal guardian unwilling or unable to provide written informed consent.&#xD;
&#xD;
          -  Known congenital anomaly, developmental disorder or severe developmental delay&#xD;
&#xD;
          -  If not possible to test the child due to physical or behavioural problems&#xD;
&#xD;
          -  Children of multiple birth e.g. twin, triplets&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>16 Months</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Sheikh Jamal Hossain, MPH</last_name>
    <phone>02-01712191414</phone>
    <email>sheikh.jamal@icddrb.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jena D Hamadani, PhD</last_name>
    <phone>02-01713093849</phone>
    <email>jena@icddrb.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>ICDDR,B</name>
      <address>
        <city>Dhaka</city>
        <zip>1212</zip>
        <country>Bangladesh</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jena D. Hamadani, Ph. D.</last_name>
      <phone>886-052-332</phone>
      <phone_ext>2353</phone_ext>
      <email>jena@icddrb.org</email>
    </contact>
  </location>
  <location_countries>
    <country>Bangladesh</country>
  </location_countries>
  <reference>
    <citation>Black MM, Walker SP, Fernald LCH, Andersen CT, DiGirolamo AM, Lu C, McCoy DC, Fink G, Shawar YR, Shiffman J, Devercelli AE, Wodon QT, Vargas-Baron E, Grantham-McGregor S; Lancet Early Childhood Development Series Steering Committee. Early childhood development coming of age: science through the life course. Lancet. 2017 Jan 7;389(10064):77-90. doi: 10.1016/S0140-6736(16)31389-7. Epub 2016 Oct 4.</citation>
    <PMID>27717614</PMID>
  </reference>
  <reference>
    <citation>Hamadani JD, Tofail F, Huda SN, Alam DS, Ridout DA, Attanasio O, Grantham-McGregor SM. Cognitive deficit and poverty in the first 5 years of childhood in Bangladesh. Pediatrics. 2014 Oct;134(4):e1001-8. doi: 10.1542/peds.2014-0694.</citation>
    <PMID>25266433</PMID>
  </reference>
  <reference>
    <citation>Afsana K, Wahid SS. Health care for poor people in the urban slums of Bangladesh. Lancet. 2013 Dec 21;382(9910):2049-51. doi: 10.1016/S0140-6736(13)62295-3. Epub 2013 Nov 21. No abstract available.</citation>
    <PMID>24268606</PMID>
  </reference>
  <reference>
    <citation>Robertson L, Mushati P, Eaton JW, Dumba L, Mavise G, Makoni J, Schumacher C, Crea T, Monasch R, Sherr L, Garnett GP, Nyamukapa C, Gregson S. Effects of unconditional and conditional cash transfers on child health and development in Zimbabwe: a cluster-randomised trial. Lancet. 2013 Apr 13;381(9874):1283-92. doi: 10.1016/S0140-6736(12)62168-0. Epub 2013 Feb 27.</citation>
    <PMID>23453283</PMID>
  </reference>
  <reference>
    <citation>Pega F, Liu SY, Walter S, Pabayo R, Saith R, Lhachimi SK. Unconditional cash transfers for reducing poverty and vulnerabilities: effect on use of health services and health outcomes in low- and middle-income countries. Cochrane Database Syst Rev. 2017 Nov 15;11(11):CD011135. doi: 10.1002/14651858.CD011135.pub2.</citation>
    <PMID>29139110</PMID>
  </reference>
  <reference>
    <citation>Ahmed SM, Evans TG, Standing H, Mahmud S. Harnessing pluralism for better health in Bangladesh. Lancet. 2013 Nov 23;382(9906):1746-55. doi: 10.1016/S0140-6736(13)62147-9. Epub 2013 Nov 21.</citation>
    <PMID>24268003</PMID>
  </reference>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>November 19, 2018</study_first_submitted>
  <study_first_submitted_qc>November 22, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 27, 2018</study_first_posted>
  <last_update_submitted>February 10, 2022</last_update_submitted>
  <last_update_submitted_qc>February 10, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 11, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Bangladesh</keyword>
  <keyword>Cognitive development</keyword>
  <keyword>behavior</keyword>
  <keyword>quality of life</keyword>
  <keyword>psycho social stimulation</keyword>
  <keyword>lactating allowance</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03753646
org study id: PR-18035
nct id: NCT03753646
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Burden:

      Provision of health care to urban poor population is a great challenge because of supply and
      demand barriers in the urban health system, which is considered patchy and fragmented. The
      poor urban people, especially mothers have little access to government health facilities. The
      health care platform is not well designed in primary health care delivery for urban health
      system but presently almost 30 percent people are living in urban area of the country.

      Knowledge gap:

      Little is known about what happen if psycho social stimulation is provided using urban
      lactating allowance program on children's cognition and behavior. There is little information
      about nature and bottleneck of Early Childhood Development (ECD) activities available in the
      urban Bangladesh.

      Relevance:

      This is an opportunity to develop a combined package integrating psycho social stimulation
      with the existing urban lactating allowance program on disadvantaged children's development.

      As the urban health system is complex, patchy and fragmented, prior to this intervention An
      analysis will be done on ECD services and its bottleneck in urban area through Tanahashi
      framework.

      Hypothesis (if any):

      Adding psycho social stimulation to urban lactating allowance program will have additional
      effect on children's cognitive, motor and language development and behavior compared to the
      comparison group

      Secondary Hypothesis:

      Additionally the intervention will- improve mothers' quality of life and reduce their
      depressive symptoms be cost effective,

      Objectives:

        -  To evaluate the effect of integrated urban lactating allowance and psycho social
           stimulation on children's cognitive, motor and language development and behavior

        -  To measure nature and bottleneck of ECD services in urban Bangladesh

      Secondary objectives:

      To measure effect of the programs on:

        -  mothers' quality of life and mental health (depression symptoms)

        -  cost effectiveness of the intervention

      Methods: A two-arm, Cluster Randomized Controlled Trial: i) Lactating allowance + Psycho
      social stimulation; (ii) Only lactating allowance

      Outcome measures/variables: Children's cognitive, motor and language development measured on
      Bayley-III, behavior on Wolke's rating scales, Mother's quality of life and depressive
      symptoms , household food security status, socioeconomic status, quality of home stimulation
      using family care indicators, Mother's knowledge on child care and development, children's
      growth measured by length/height, weight and head circumference,mothers' height, weight and
      mid upper arm circumference, direct and indirect cost of the project.
It is estimated that 250 million children do not reach their potential due to poverty,
      inadequate stimulation and associated risk factors in low and middle income countries.

      In Bangladesh more than 50% of children under 5 years are at risk of developmental delay.
      Urban population is about 28% and it is expected to rise to more than 40% by 2030. In fact,
      urbanization in Bangladesh is rapidly growing but is not well planned. Poor urban women and
      children are vulnerable in terms of health and education .

      The urban health care facilities are fragmented and patchy and every year rise in population
      is putting more pressure on health system. Moreover, there is huge economic disparity between
      rich and poor in the urban areas and poorer people have little access to health care due to
      both supply and demand barriers. So the situation is rolling more difficult every day.

      Ministry of Women and Children Affairs (MOWCA) has taken initiatives to help urban poor
      mothers through lactating allowance (LA) and limited health education programs. A study
      conducted in Zimbabwe documented that unconditional cash transfer showed an increase in
      receiving children's birth certificate and immunization in the age group of 0-4years and
      school attendance in 6-12 years. Recent systematic review concluded that unconditional cash
      transfer may not improve health services use in children and adult in low and middle income
      countries but may have positive impact on food choices and food security. It is expected that
      this urban lactating allowance will develop economic capacity of people, empower women,
      improve their quality of life and reduce gender gap.

      Very few ECD programs are available for poor urban children especially for the 1st thousand
      days. The idea is to develop a combined package integrating psycho social stimulation with
      the existing urban lactating allowance program and measuring its effects on disadvantaged
      children's development.

      As the urban health system is complex, patchy and fragmented, prior to this intervention an
      analysis will be done on ECD services and its bottleneck in the project area through
      Tanahashi framework. A facility assessment will be done to understand nature of ECD services.
      A meeting will be conducted with relevant experts to finalize the services delivery mechanism
      of the intervention.

      Research Design and Methods:

      This study will follow two sequential stages:

      Stage I: Understand nature and analyse bottleneck of ECD services in selected urban areas of
      Bangladesh through a survey using Tanahasi framework.

      Stage II: Document that adding ECD activities to urban lactating allowance program will
      improve children's cognition, motor, language and behaviour.

      Methodology for stage I:

      First, an analysis will be done on ECD program in urban area through Tanahashi framework. A
      documentation will be done on availability, accessibility, utilization and adequate coverage
      of the ECD activities.

      ECD and related services will be analyzed through:

      a) Household Survey and b) Facility assessment

        1. Household survey A survey will be conducted with 426 mothers having child less than five
           years. On an average 22 respondents will be recruited from each cluster. the total
           clusters will be 20.

           Sample size was calculated assuming 50% effective coverage, 20% error, 95% confidence
           interval and 10% refusal rate the total sample size calculated was 426 in an urban
           setting..

        2. Facility Assessment Moreover, ECD or relevant services will be collected through
           visiting service delivery facilities. government and private hospitals, NGOs and schools
           (kindergarten) will be visited and data will be collected on services available.

      At the end of this stage, a stakeholders meeting with relevant experts will be conducted to
      finalize a service delivery mechanism

      Methodology for stage II:

      The main aim is to document that adding ECD activities to urban lactating allowance program
      improves children's cognition, language and motor and behaviour.

      Study design:

      This is a cluster randomized controlled trial of the effects of adding psycho social
      stimulation to the existing lactating allowance of the country with 2 arms: i) Psycho social
      stimulation+ Urban lactating allowance and ii) Only urban lactating allowance.

      Selection of the study area:

      A municipality will be selected for this study. The Initial plan is to conduct the study in
      Rangpur City Corporation.

      Recruitment:

      There will be 20 clusters (10 interventions & 10 comparisons) and 30 mother child dyads in
      each cluster. In Rangpure City Corporation there are 33 Wards. A Ward will be considered as a
      cluster. Cluster will be assigned randomly to intervention or comparisions group. A buffer
      zone will be made to reduce spill over effect with remaining Wards and or villages.

      As the Government is providing urban lactating allowance to 2000 mothers in Rangpur City
      Corporation, it is expected that there will be approximately at least 50 mother child dyads
      in each cluster. 30 participants will be selected from the list considering mothers lower age
      and/or those with single child (if available).

      Sample Size:

      In total, sample is 600. Previous studies of psycho social stimulation alone achieved an
      effect size of 0.4 SD on children's development. In this study, lactating allowance (cash) as
      an intervention that might have also positive effect on the child development. But to be on
      the safe side, it is assumed that an effect size of 0.35 SD, 80% power, 95% confidence
      interval, 1.58 cluster design effect and 25% drop-out rate the sample size was calculated to
      be 300 in each arm with 30 children in each of the 20 clusters.

      Data Analysis:

      Data will be checked for normality. Appropriate measures will be taken if there are any
      abnormal distributions. Frequency table and percentage will be used to present nature of ECD
      services and its bottleneck. Service availability would be presented in a table through
      facility assessment and the bottlenecks (accessibility, utilization and coverage) will also
      be presented through interviews with mothers. For intervention trial, differences between
      groups in background characteristics will be analyzed using t-test for continuous variables
      and chi-square test for categorical variables.. Effect of the ECD intervention will be
      measured using intention-to-treat analysis controlling for the clustering effect in
      multivariate regression analysis. All covariates will be controlled and effect modifier and
      mulnicolinearity will be checked before regression analysis. Quality of life data will be
      analysed based on WHO guideline for WHOQoL tools.. Similarly, total score of SRQ will be
      calculated and then differences between arms will be analysed.

      Cost-effectiveness Analysis:

      The objective of the study is to estimate the resource use and costs associated with
      interventions. Direct and indirect cost will be measured for all the groups. Average costs
      per participants will be calculated by multiplying the cost of resource items by their
      respective unit costs. Outcomes will be generated from the study after the intervention and
      the differences will be measured before and after the intervention in two groups. Then the
      incremental cost-effectiveness ratio (ICER) will be used in cost-effectiveness analysis.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: We will integrate ECD services to Bangladesh government lactating allowance to measure children's neurocognitive behavior in urban area of Bangladesh.
primary purpose: Other
masking: Single (Outcomes Assessor)
masking description: The Assessor who will measure children's cognitive development and behavor and other measurements will be masked
measure: Children's cognitive composite score ranging from 55 to 145 using Bayley Scales of Infant and Toddler Development (Bayley-III)
time frame: Children's cognitive composite score ranging from 55 to 145 using Bayley Scales of Infant and Toddler Development (Bayley-III) after one year intervention
description: Children's cognitive composite score ranging from 55 to 145 using Bayley Scales of Infant and Toddler Development (Bayley-III). Higher values represent a better status
measure: Children's language composite score ranging from 45 to 155 using Bayley Scales of Infant and Toddler Development (Bayley-III)
time frame: Children's language composite score ranging from 45 to 155 using Bayley Scales of Infant and Toddler Development (Bayley-III) after one year intervention
description: Children's language composite score ranging from 45 to 155 using Bayley Scales of Infant and Toddler Development (Bayley-III). Higher values represent a better status
measure: Children's motor composite score ranging from 45 to 155 using Bayley Scales of Infant and Toddler Development (Bayley-III)
time frame: Children's motor composite score ranging from 45 to 155 using Bayley Scales of Infant and Toddler Development (Bayley-III) after one year intervention
description: Children's motor composite score ranging from 45 to 155 using Bayley Scales of Infant and Toddler Development (Bayley-III). Higher values represent a better status
measure: Children's approach behaviour using Wolk's behavior rating scale ranging from 1 to 9
time frame: Children's approach behaviour using Wolk's behavior rating scale ranging from 1 to 9 after one year intervention
description: Children's approach behaviour using Wolk's behavior rating scale ranging from 1 to 9 during Bayley. Higher values represent a better status
measure: Children's general emotion tone behaviour using Wolk's behavior rating scale ranging from 1 to 9
time frame: Children's general emotion tone behaviour using Wolk's behavior rating scale ranging from 1 to 9 after one year intervention
description: Children's general emotion tone behaviour using Wolk's behavior rating scale ranging from 1 to 9 during Bayley. Higher values represent a better status
measure: Children's activity behaviour using Wolk's behavior rating scale ranging from 1 to 9
time frame: Children's activity behaviour using Wolk's behavior rating scale ranging from 1 to 9 after one year intervention
description: Children's activity behaviour using Wolk's behavior rating scale ranging from 1 to 9 during Bayley. Higher values represent a more active status.
measure: Children's cooperation behaviour using Wolk's behavior rating scale ranging from 1 to 9
time frame: Children's cooperation behaviour using Wolk's behavior rating scale ranging from 1 to 9 after one year intervention
description: Children's cooperation behaviour using Wolk's behavior rating scale ranging from 1 to 9 during Bayley. Higher values represent a better status
measure: Children's vocalization behaviour using Wolk's behavior rating scale ranging from 1 to 9
time frame: Children's vocalization behaviour using Wolk's behavior rating scale ranging from 1 to 9 after one year intervention
description: Children's vocalization behaviour using Wolk's behavior rating scale ranging from 1 to 9 during Bayley. Higher values represent a better status
measure: Children's weight
time frame: Change children's weight after one year intervention
description: Children's weight will be measured in Gram
measure: Children's height
time frame: Change children's height after one year intervention
description: Children's height will be measured in Gram
measure: Children's Mid Upper Arm circumference (MUAC)
time frame: Change children's MUAC after one year intervention
description: Children's MUAC will be measured by millimeter
measure: Mothers' weight
time frame: Change mother's weight after one year intervention
description: Mothers' weight will be measured in Gram
measure: Mothers' height
time frame: Change mother's height after one year intervention
description: Mothers' height will be measured by Centimeter
measure: Mothers' Mid Upper Arm circumference (MUAC)
time frame: Change mother's Mid Upper Arm circumference (MUAC) after one year intervention
description: Mothers' Mid Upper Arm circumference (MUAC) will be measured by Centimeter
measure: Mothers' depressive symptom
time frame: Change mother's depression status after one year intervention
description: Mothers' depressive symptom will be measured by Self-Regulation Questionnaire (SRQ). higher values represent a worse mental status
measure: Mothers' quality of life status
time frame: Change mother's quality of life status after one year intervention
description: Mothers' quality of life status will be measured by World Health Organization (WHO) quality of life questionnaire
measure: Family's monthly food security status
time frame: Change family's food security status after one year intervention
description: Family's monthly food security status will be measured by Household Food Insecurity Access Scale (HFIAS) questionnaire. The status will be measured as per HFIAS analysis guideline developed by the U.S. Agency for International Development (USAID).
Measurement of Food Access:
Indicator Guide
measure: Domestic violence (mothers)
time frame: Change family's domestic violence status after one year intervention
description: Domestic violence (mothers) monthly status will be measured by questionnaire
measure: Family care indicators (FCI)
time frame: Change of FCI after one year intervention
description: Family care indicators (FCI) will be measured by questionnaire. Higher values represent a better environment
measure: Mothers' knowledge on parenting
time frame: Change of mothers' knowledge after one year intervention
description: Mothers' knowledge on parenting questionnaire will be used
measure: Family's health seeking behavior
time frame: Change family's health seeking behaviour status after one year intervention
description: Family's health seeking behavior status will be measured by questionnaire
measure: Family's income
time frame: Change family's income status after one year intervention
description: Family's monthly income status will be measured by questionnaire
measure: Family's expenditure
time frame: Change family's expenditure status after one year intervention
description: Family's expenditure status will be measured by questionnaire
arm group label: Lactating allowance and psycho social stimulation
arm group type: Experimental
description: Mothers will receive lactating allowance and psycho social stimulation
arm group label: Only lactating allowance
arm group type: No Intervention
description: Mothers will receive only lactating allowance
intervention type: Other
intervention name: Lactating allowance and psycho social stimulation
description: Mothers will receive lactating allowance and psycho social stimulation
arm group label: Lactating allowance and psycho social stimulation
criteria: 
gender: All
minimum age: 6 Months
maximum age: 16 Months
healthy volunteers: Accepts Healthy Volunteers
last name: Sheikh Jamal Hossain, MPH
phone: 02-01712191414
email: sheikh.jamal@icddrb.org
last name: Jena D Hamadani, PhD
phone: 02-01713093849
email: jena@icddrb.org
facility: 
status: Recruiting
contact: 
country: Bangladesh
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PMID: 27717614
citation: Hamadani JD, Tofail F, Huda SN, Alam DS, Ridout DA, Attanasio O, Grantham-McGregor SM. Cognitive deficit and poverty in the first 5 years of childhood in Bangladesh. Pediatrics. 2014 Oct;134(4):e1001-8. doi: 10.1542/peds.2014-0694.
PMID: 25266433
citation: Afsana K, Wahid SS. Health care for poor people in the urban slums of Bangladesh. Lancet. 2013 Dec 21;382(9910):2049-51. doi: 10.1016/S0140-6736(13)62295-3. Epub 2013 Nov 21. No abstract available.
PMID: 24268606
citation: Robertson L, Mushati P, Eaton JW, Dumba L, Mavise G, Makoni J, Schumacher C, Crea T, Monasch R, Sherr L, Garnett GP, Nyamukapa C, Gregson S. Effects of unconditional and conditional cash transfers on child health and development in Zimbabwe: a cluster-randomised trial. Lancet. 2013 Apr 13;381(9874):1283-92. doi: 10.1016/S0140-6736(12)62168-0. Epub 2013 Feb 27.
PMID: 23453283
citation: Pega F, Liu SY, Walter S, Pabayo R, Saith R, Lhachimi SK. Unconditional cash transfers for reducing poverty and vulnerabilities: effect on use of health services and health outcomes in low- and middle-income countries. Cochrane Database Syst Rev. 2017 Nov 15;11(11):CD011135. doi: 10.1002/14651858.CD011135.pub2.
PMID: 29139110
citation: Ahmed SM, Evans TG, Standing H, Mahmud S. Harnessing pluralism for better health in Bangladesh. Lancet. 2013 Nov 23;382(9906):1746-55. doi: 10.1016/S0140-6736(13)62147-9. Epub 2013 Nov 21.
PMID: 24268003
responsible party type: Sponsor
sharing ipd: No