<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/NCT02234726</url>
  </required_header>
  <id_info>
    <org_study_id>GCC 0349-03</org_study_id>
    <nct_id>NCT02234726</nct_id>
  </id_info>
  <brief_title>Improving Early Childhood Development in Zambia</brief_title>
  <acronym>IECDZ</acronym>
  <official_title>Improving Early Childhood Development in Zambia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zambia Center for Applied Health Research and Development</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Grand Challenges Canada</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>PATH</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Department for International Development, United Kingdom</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Zambia Center for Applied Health Research and Development</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 evaluate the impact of a community-based early childhood&#xD;
      development (ECD) program on children's physical and cognitive development. Under the&#xD;
      program, targeted communities will be assigned a trained Child Development Agent (CDA) who&#xD;
      will have four main tasks and responsibilities: 1) biweekly screening and management&#xD;
      (including referral) of acute malnutrition in children; 2) encouragement of caregivers to&#xD;
      utilize routine care services for children; 3) screening for symptoms of acute diseases&#xD;
      including malaria, diarrhea, and pneumonia and referral for diagnosis and treatment; and 4)&#xD;
      organization and mentoring of biweekly caregiver meetings to discuss parenting and promote&#xD;
      early childhood cognitive stimulation. The investigators will enroll at baseline around 600&#xD;
      children ages 6 - 12 months and their caregivers, and randomize them at the community-level&#xD;
      to receive the ECD program or to remain in the control group. The study period will be one&#xD;
      year. At end line, the investigators will collect important indicators of child physical and&#xD;
      cognitive development to assess program impact. If the program shows both feasibility and&#xD;
      impact, there is the potential to integrate program interventions into existing national&#xD;
      community-based health initiatives.&#xD;
&#xD;
      Amendment: the study period has been extended for a second year. After a five month gap when&#xD;
      no intervention was provided, biweekly (i.e., fortnightly) community-based parenting groups&#xD;
      were restarted in intervention clusters. In the second year of the intervention, CDAs no&#xD;
      longer visit households.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to evaluate the impact of a community-based early childhood&#xD;
      development (ECD) program on child physical and cognitive development. Central to the ECD&#xD;
      program is a cadre of community-based health workers called Child Development Agents (CDAs).&#xD;
      CDAs have four main tasks and responsibilities: 1) Biweekly screening and management&#xD;
      (including referral) of acute malnutrition in children; 2) Encouragement of caregivers to&#xD;
      utilize routine care services for children (immunizations, growth monitoring, and vitamin A&#xD;
      supplementation); 3) Screening for symptoms of acute diseases including malaria, diarrhea,&#xD;
      and pneumonia and referral for diagnosis and treatment; and 4) Organization and mentoring of&#xD;
      weekly meetings for caregivers to discuss parenting issues and promote early childhood&#xD;
      cognitive stimulation.&#xD;
&#xD;
      Protocols for the community-based evaluation and management of children with acute&#xD;
      malnutrition are based on the draft Zambian Community Integrated Management of Acute&#xD;
      Malnutrition (CIMAM) guidelines. Children with complicated severe acute malnutrition (SAM)&#xD;
      are referred to the nearest health center for evaluation and, if SAM is confirmed based on&#xD;
      mid-upper arm circumference (MUAC), then referred to an inpatient feeding center for&#xD;
      management. All children with moderate acute malnutrition (MAM) and uncomplicated SAM are&#xD;
      administered an appetite test at the health center. Children who pass the appetite test are&#xD;
      managed locally as outpatients. Children with acute infectious diseases are treated following&#xD;
      the Ministry of Health's adaptation of the Integrated Management of Childhood Illness (IMCI)&#xD;
      guidelines and those with complicated SAM or feeding difficulties are referred to higher&#xD;
      level facilities (feeding centers). As part of the ECD program, clinical staff members at&#xD;
      study health centers receive a short training to improve their adherence to IMCI and CIMAM&#xD;
      guidelines.&#xD;
&#xD;
      One aspect of the IECDZ program that is of particular interest from a policy and evaluation&#xD;
      perspective is the explicit focus on improving communication between CDAs and clinical staff&#xD;
      at facilities handling undernourished children. As part of the ECD program, CDAs meet with&#xD;
      staff at referral health centers on a regular basis, and discuss strategies to improve&#xD;
      nutritional outcomes of children falling behind.&#xD;
&#xD;
      In addition to these regular meetings, the ECD program strengthens the linkages between CDAs&#xD;
      and health centers with a novel mHealth intervention. When a CDA refers a child to a health&#xD;
      center for evaluation of acute malnutrition, danger signs, or signs/symptoms suggestive of&#xD;
      malaria, pneumonia or diarrhea, the officer-in-charge at the health center receives an short&#xD;
      message service (SMS) and a paper referral form to make them aware of the child and their&#xD;
      provisional diagnosis. Once the referred child has been attended to at the facility, health&#xD;
      center staff members will then send an SMS back to the CDA to make them aware of the final&#xD;
      diagnosis and management plan. If the health center refers the child to a feeding center, an&#xD;
      SMS is sent to the feeding center along with a paper referral form. All text messages within&#xD;
      the proposed system are free of charge to the end users. The mobile health (mHealth) system&#xD;
      is meant to improve communication between health workers operating at various levels of the&#xD;
      health system. Caregivers themselves do not receive SMS updates. Rather, CDAs will&#xD;
      communicate all updates on the health and nutritional status of children directly to&#xD;
      caregivers.&#xD;
&#xD;
      The primary objectives of the ECD program are to:&#xD;
&#xD;
        1. Improve community-based screening for uncomplicated acute malnutrition and to strengthen&#xD;
           referral to and the quality of management of malnourished children at local health&#xD;
           centers;&#xD;
&#xD;
        2. Conduct community-based screening and referral for management of common childhood&#xD;
           diseases (malaria, diarrhea, and pneumonia);&#xD;
&#xD;
        3. Strengthen the continuum of care for children with acute malnutrition and disease using&#xD;
           an innovative mHealth intervention to link CDAs, the children that they are screening,&#xD;
           and health centers and feeding centers; and&#xD;
&#xD;
        4. Improve early cognitive development through community-based weekly meetings with&#xD;
           caregivers.&#xD;
&#xD;
      The proposed evaluation will be structured around the ECD program roll out, and will employ a&#xD;
      cluster-randomized trial design. For the purposes of the evaluation, a cluster is demarcated&#xD;
      by the boundaries of a health zone, a geographic unit defined and used by the Zambia Ministry&#xD;
      of Health to determine catchment populations for public health facilities. Each health zone&#xD;
      and the children recruited from within the zone comprise a cluster for the trial. The ECD&#xD;
      interventions will be implemented in 15 randomly selected health zones across five facilities&#xD;
      starting in August 2014. The remaining 15 health zones in the catchments of the five study&#xD;
      facilities will continue using current practices and will serve as controls. Within each&#xD;
      health zone, a total of around 20 child/caregiver pairs will be recruited and enrolled in the&#xD;
      evaluation. In total, the investigators anticipate around 300 child/caregiver pairs being&#xD;
      enrolled in each arm of the study, for a total of 600 child/caregiver pairs.&#xD;
&#xD;
      The study sample will be randomized at the level of the health zone to either the ECD program&#xD;
      or to the control group using stratified random sampling methods. Prior to randomization,&#xD;
      basic demographic information will be collected on all health zones, including: distance to&#xD;
      the study health center, total population, and number of eligible children ages 6 to 12&#xD;
      months. Next, zones will be stratified according to these demographic data. Finally, within&#xD;
      strata zones will be assigned to either the ECD intervention or to the control group using a&#xD;
      random number generator to achieve balance within strata.&#xD;
&#xD;
      Study data will be collected from four main sources: 1) a baseline interview with study&#xD;
      caregivers; 2) an endline interview with caregivers and a child assessment; 3) IECDZ program&#xD;
      monitoring systems, including CDA records and SMS software; and 4) semi-structured interviews&#xD;
      with CDAs and clinic staff.&#xD;
&#xD;
      Baseline caregiver interview - Study CDAs will conduct a baseline survey of both control and&#xD;
      intervention households which will include: a) basic demographic and socioeconomic status, b)&#xD;
      availability of books, toys and other reading material at home, time spent by caregivers&#xD;
      reading to the child, as well as time spent by caregivers playing with the child, c)&#xD;
      anthropometric screening (weight, height, and MUAC), d) review of vaccinations and child&#xD;
      health visits using child health card, e) assessment of maternal or caregiver mental&#xD;
      well-being, f) assessment of maternal depression with the self-reporting questionnaire-20&#xD;
      (SRQ-20), and g) presence of other early childhood development programs in the community.&#xD;
&#xD;
      End line caregiver interview and child assessment - Twelve months after enrollment all&#xD;
      children will be visited for a final interview and assessment. This assessment will include&#xD;
      the questions asked at baseline as well as an assessment of child development using a&#xD;
      standardized test-the INTERGROWTH 21st century assessment tool.&#xD;
&#xD;
      ECD program monitoring systems - Data on key process indicators will be collected from ECD&#xD;
      program records to assess the activities of CDAs and study clinics. Important indicators&#xD;
      include: a) volume of CDA household visits; b) volume of children identified and referred for&#xD;
      malnutrition and/or disease; c) volume of successful referrals; and d) volume of SMS sent&#xD;
      between CDAs and study clinics. Additional ECD program monitoring systems dedicated to the&#xD;
      caregiver groups' cognitive stimulation are: a) frequency of caregiver groups, b) caregiver&#xD;
      knowledge of topics covered by the curriculum, and c) measures of caregiver-child interaction&#xD;
      quality. These data do not exist for control areas, so they will not be used to evaluate the&#xD;
      impact of the ECD program. However, these data will provide important information that will&#xD;
      be used to better understand any program impacts that are identified.&#xD;
&#xD;
      Interviews with CDAs and clinic staff - A series of semi-structured interviews will be&#xD;
      conducted with CDAs and clinic staff members to assess both awareness of child nutrition and&#xD;
      disease issues and general perceptions of the ECD program. These interviews will be conducted&#xD;
      with all study CDAs and staff from all study facilities at three time points.&#xD;
&#xD;
      For analyses, the primary independent variable of interest is receipt of the ECD program.&#xD;
      Assuming proper randomization, we anticipate that all factors that might potentially confound&#xD;
      the relationships of interest are uncorrelated with receipt of the program. We will compare&#xD;
      baseline characteristics between the two groups to assess balance. We will collect data on&#xD;
      potential confounders to increase precision, analyze heterogeneity and, if necessary, control&#xD;
      for any potential imbalance. Potential confounders include: maternal and paternal education,&#xD;
      assets, income and employment, family composition and child gender. We will also control for&#xD;
      baseline height-for-age z-score and other baseline child health measures.&#xD;
&#xD;
      Categorical variables will be compared between groups using a chi-square test, or Fisher's&#xD;
      exact test if cell sizes are small; continuous variables using a t-test if normally&#xD;
      distributed or non-parametric Wilcoxon rank sum tests, if non-normal. We will model our&#xD;
      impact measures as a function of treatment and controls using a standard regression&#xD;
      framework.&#xD;
&#xD;
      Amendment: the study period has been extended for a second year.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2014</start_date>
  <completion_date type="Actual">March 2017</completion_date>
  <primary_completion_date type="Actual">December 2016</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>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Stunting</measure>
    <time_frame>One year starting with baseline (August-September 2014) and finishing with end line (September 2015); Amendment: also measured at year two (extension) endline</time_frame>
    <description>Heights of all study children will be measured. Height-for-age z-scores will be calculated using standard WHO criteria. Stunting will be defined as having a height-for-age z-score &lt; -2. The difference in the prevalence of stunting between children in the intervention and comparison areas will be determined.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cognitive function</measure>
    <time_frame>End line (after one year); Amendment: BSID-III at year two (extension) endline</time_frame>
    <description>Study children will be assessed at end line using the INTERGROWTH 21st century instrument. Scores will be standardized within the study sample for analysis. Scores of children in intervention health zones will be compared with children in comparison areas to determine differences.&#xD;
Amendment: at year two (extension) endline, children are assessed using the Bayley Scale for Infant and Toddler Development (BSID-III). Scores are standardized within the study sample for analysis.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Measles vaccine 2nd dose</measure>
    <time_frame>End line (one year)</time_frame>
    <description>We will collect data on whether study children have received a second dose of measles vaccine; Zambian Ministry of Health guidelines indicate that a second dose should be given to all children at age 15 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment of severe acute malnutrition (SAM)</measure>
    <time_frame>Baseline and end line (one year)</time_frame>
    <description>Caregivers will be asked to report on whether a child received treatment for SAM at a health center.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Caregiver awareness of child development</measure>
    <time_frame>Baseline and end line (one year)</time_frame>
    <description>Caregivers will be asked at baseline and end line about their child's nutritional and developmental status, and their responses will be compared to objective measures (e.g., stunting, INTERGROWTH z-score).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">526</enrollment>
  <condition>Stunting</condition>
  <condition>Child Development</condition>
  <arm_group>
    <arm_group_label>Early Childhood Development Program</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Treatment clusters will be assigned a trained Child Development Agent (CDA) who will have four main tasks and responsibilities: 1) biweekly screening and management (including referral) of acute malnutrition in children; 2) encouragement of caregivers to utilize routine care services for children; 3) screening for symptoms of acute diseases including malaria, diarrhea, and pneumonia and referral for diagnosis and treatment; and 4) organization and mentoring of biweekly caregiver meetings to discuss parenting and promote early childhood cognitive stimulation.&#xD;
Amendment: during second year extension, CDAs are responsible for organizing and mentoring biweekly (i.e., fortnightly) caregiver meetings. They no longer conduct household visits.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Children residing in comparison health zones will only receive baseline and end line evaluations of their health and developmental status. There will be no active intervention in the comparison areas during the course of the study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Early Childhood Development Program</intervention_name>
    <description>A cadre of community-based health workers, Child Development Agents (CDAs), have four main tasks and responsibilities: 1) biweekly screening and management (including referral) of acute malnutrition in children; 2) encouragement of caregivers to utilize routine care services for children; 3) screening for symptoms of acute diseases and referral for diagnosis and treatment; and 4) organization and mentoring of weekly meetings for caregivers to discuss parenting issues and promote early childhood cognitive stimulation.&#xD;
Amendment: during second year extension, CDAs are responsible for organizing and mentoring biweekly (i.e., fortnightly) caregiver meetings. They no longer conduct household visits.</description>
    <arm_group_label>Early Childhood Development Program</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria&#xD;
&#xD;
          -  Child ages 6 to 12 months at the time of intervention launch residing in the catchment&#xD;
             areas of the five study health facilities&#xD;
&#xD;
          -  Child's mother or main caregiver must be 15 years or older&#xD;
&#xD;
          -  Child's primary caregiver must be a female (because the participants in the caregiver&#xD;
             groups may feel uncomfortable discussing certain issues if a man is present)&#xD;
&#xD;
        Exclusion criteria&#xD;
&#xD;
          -  Caregivers who are unwilling to provide informed consent&#xD;
&#xD;
          -  Families that plan to move from their health center catchment zone during the twelve&#xD;
             month period of the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>12 Months</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Davidson Hamer</last_name>
    <role>Principal Investigator</role>
    <affiliation>Boston University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Choma District Medical Office</name>
      <address>
        <city>Choma</city>
        <state>Southern</state>
        <country>Zambia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pemba District Medical Office</name>
      <address>
        <city>Pemba</city>
        <state>Southern</state>
        <country>Zambia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Zambia</country>
  </location_countries>
  <verification_date>June 2017</verification_date>
  <study_first_submitted>August 8, 2014</study_first_submitted>
  <study_first_submitted_qc>September 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 9, 2014</study_first_posted>
  <last_update_submitted>June 16, 2017</last_update_submitted>
  <last_update_submitted_qc>June 16, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">June 20, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>child health</keyword>
  <keyword>child development</keyword>
  <keyword>malnutrition</keyword>
  <keyword>stunting</keyword>
  <keyword>community-based health services</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Growth Disorders</mesh_term>
  </condition_browse>
  <!-- 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/NCT02234726
org study id: GCC 0349-03
nct id: NCT02234726
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to evaluate the impact of a community-based early childhood
      development (ECD) program on children's physical and cognitive development. Under the
      program, targeted communities will be assigned a trained Child Development Agent (CDA) who
      will have four main tasks and responsibilities: 1) biweekly screening and management
      (including referral) of acute malnutrition in children; 2) encouragement of caregivers to
      utilize routine care services for children; 3) screening for symptoms of acute diseases
      including malaria, diarrhea, and pneumonia and referral for diagnosis and treatment; and 4)
      organization and mentoring of biweekly caregiver meetings to discuss parenting and promote
      early childhood cognitive stimulation. The investigators will enroll at baseline around 600
      children ages 6 - 12 months and their caregivers, and randomize them at the community-level
      to receive the ECD program or to remain in the control group. The study period will be one
      year. At end line, the investigators will collect important indicators of child physical and
      cognitive development to assess program impact. If the program shows both feasibility and
      impact, there is the potential to integrate program interventions into existing national
      community-based health initiatives.

      Amendment: the study period has been extended for a second year. After a five month gap when
      no intervention was provided, biweekly (i.e., fortnightly) community-based parenting groups
      were restarted in intervention clusters. In the second year of the intervention, CDAs no
      longer visit households.
The purpose of this study is to evaluate the impact of a community-based early childhood
      development (ECD) program on child physical and cognitive development. Central to the ECD
      program is a cadre of community-based health workers called Child Development Agents (CDAs).
      CDAs have four main tasks and responsibilities: 1) Biweekly screening and management
      (including referral) of acute malnutrition in children; 2) Encouragement of caregivers to
      utilize routine care services for children (immunizations, growth monitoring, and vitamin A
      supplementation); 3) Screening for symptoms of acute diseases including malaria, diarrhea,
      and pneumonia and referral for diagnosis and treatment; and 4) Organization and mentoring of
      weekly meetings for caregivers to discuss parenting issues and promote early childhood
      cognitive stimulation.

      Protocols for the community-based evaluation and management of children with acute
      malnutrition are based on the draft Zambian Community Integrated Management of Acute
      Malnutrition (CIMAM) guidelines. Children with complicated severe acute malnutrition (SAM)
      are referred to the nearest health center for evaluation and, if SAM is confirmed based on
      mid-upper arm circumference (MUAC), then referred to an inpatient feeding center for
      management. All children with moderate acute malnutrition (MAM) and uncomplicated SAM are
      administered an appetite test at the health center. Children who pass the appetite test are
      managed locally as outpatients. Children with acute infectious diseases are treated following
      the Ministry of Health's adaptation of the Integrated Management of Childhood Illness (IMCI)
      guidelines and those with complicated SAM or feeding difficulties are referred to higher
      level facilities (feeding centers). As part of the ECD program, clinical staff members at
      study health centers receive a short training to improve their adherence to IMCI and CIMAM
      guidelines.

      One aspect of the IECDZ program that is of particular interest from a policy and evaluation
      perspective is the explicit focus on improving communication between CDAs and clinical staff
      at facilities handling undernourished children. As part of the ECD program, CDAs meet with
      staff at referral health centers on a regular basis, and discuss strategies to improve
      nutritional outcomes of children falling behind.

      In addition to these regular meetings, the ECD program strengthens the linkages between CDAs
      and health centers with a novel mHealth intervention. When a CDA refers a child to a health
      center for evaluation of acute malnutrition, danger signs, or signs/symptoms suggestive of
      malaria, pneumonia or diarrhea, the officer-in-charge at the health center receives an short
      message service (SMS) and a paper referral form to make them aware of the child and their
      provisional diagnosis. Once the referred child has been attended to at the facility, health
      center staff members will then send an SMS back to the CDA to make them aware of the final
      diagnosis and management plan. If the health center refers the child to a feeding center, an
      SMS is sent to the feeding center along with a paper referral form. All text messages within
      the proposed system are free of charge to the end users. The mobile health (mHealth) system
      is meant to improve communication between health workers operating at various levels of the
      health system. Caregivers themselves do not receive SMS updates. Rather, CDAs will
      communicate all updates on the health and nutritional status of children directly to
      caregivers.

      The primary objectives of the ECD program are to:

        1. Improve community-based screening for uncomplicated acute malnutrition and to strengthen
           referral to and the quality of management of malnourished children at local health
           centers;

        2. Conduct community-based screening and referral for management of common childhood
           diseases (malaria, diarrhea, and pneumonia);

        3. Strengthen the continuum of care for children with acute malnutrition and disease using
           an innovative mHealth intervention to link CDAs, the children that they are screening,
           and health centers and feeding centers; and

        4. Improve early cognitive development through community-based weekly meetings with
           caregivers.

      The proposed evaluation will be structured around the ECD program roll out, and will employ a
      cluster-randomized trial design. For the purposes of the evaluation, a cluster is demarcated
      by the boundaries of a health zone, a geographic unit defined and used by the Zambia Ministry
      of Health to determine catchment populations for public health facilities. Each health zone
      and the children recruited from within the zone comprise a cluster for the trial. The ECD
      interventions will be implemented in 15 randomly selected health zones across five facilities
      starting in August 2014. The remaining 15 health zones in the catchments of the five study
      facilities will continue using current practices and will serve as controls. Within each
      health zone, a total of around 20 child/caregiver pairs will be recruited and enrolled in the
      evaluation. In total, the investigators anticipate around 300 child/caregiver pairs being
      enrolled in each arm of the study, for a total of 600 child/caregiver pairs.

      The study sample will be randomized at the level of the health zone to either the ECD program
      or to the control group using stratified random sampling methods. Prior to randomization,
      basic demographic information will be collected on all health zones, including: distance to
      the study health center, total population, and number of eligible children ages 6 to 12
      months. Next, zones will be stratified according to these demographic data. Finally, within
      strata zones will be assigned to either the ECD intervention or to the control group using a
      random number generator to achieve balance within strata.

      Study data will be collected from four main sources: 1) a baseline interview with study
      caregivers; 2) an endline interview with caregivers and a child assessment; 3) IECDZ program
      monitoring systems, including CDA records and SMS software; and 4) semi-structured interviews
      with CDAs and clinic staff.

      Baseline caregiver interview - Study CDAs will conduct a baseline survey of both control and
      intervention households which will include: a) basic demographic and socioeconomic status, b)
      availability of books, toys and other reading material at home, time spent by caregivers
      reading to the child, as well as time spent by caregivers playing with the child, c)
      anthropometric screening (weight, height, and MUAC), d) review of vaccinations and child
      health visits using child health card, e) assessment of maternal or caregiver mental
      well-being, f) assessment of maternal depression with the self-reporting questionnaire-20
      (SRQ-20), and g) presence of other early childhood development programs in the community.

      End line caregiver interview and child assessment - Twelve months after enrollment all
      children will be visited for a final interview and assessment. This assessment will include
      the questions asked at baseline as well as an assessment of child development using a
      standardized test-the INTERGROWTH 21st century assessment tool.

      ECD program monitoring systems - Data on key process indicators will be collected from ECD
      program records to assess the activities of CDAs and study clinics. Important indicators
      include: a) volume of CDA household visits; b) volume of children identified and referred for
      malnutrition and/or disease; c) volume of successful referrals; and d) volume of SMS sent
      between CDAs and study clinics. Additional ECD program monitoring systems dedicated to the
      caregiver groups' cognitive stimulation are: a) frequency of caregiver groups, b) caregiver
      knowledge of topics covered by the curriculum, and c) measures of caregiver-child interaction
      quality. These data do not exist for control areas, so they will not be used to evaluate the
      impact of the ECD program. However, these data will provide important information that will
      be used to better understand any program impacts that are identified.

      Interviews with CDAs and clinic staff - A series of semi-structured interviews will be
      conducted with CDAs and clinic staff members to assess both awareness of child nutrition and
      disease issues and general perceptions of the ECD program. These interviews will be conducted
      with all study CDAs and staff from all study facilities at three time points.

      For analyses, the primary independent variable of interest is receipt of the ECD program.
      Assuming proper randomization, we anticipate that all factors that might potentially confound
      the relationships of interest are uncorrelated with receipt of the program. We will compare
      baseline characteristics between the two groups to assess balance. We will collect data on
      potential confounders to increase precision, analyze heterogeneity and, if necessary, control
      for any potential imbalance. Potential confounders include: maternal and paternal education,
      assets, income and employment, family composition and child gender. We will also control for
      baseline height-for-age z-score and other baseline child health measures.

      Categorical variables will be compared between groups using a chi-square test, or Fisher's
      exact test if cell sizes are small; continuous variables using a t-test if normally
      distributed or non-parametric Wilcoxon rank sum tests, if non-normal. We will model our
      impact measures as a function of treatment and controls using a standard regression
      framework.

      Amendment: the study period has been extended for a second year.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Screening
masking: None (Open Label)
measure: Stunting
time frame: One year starting with baseline (August-September 2014) and finishing with end line (September 2015); Amendment: also measured at year two (extension) endline
description: Heights of all study children will be measured. Height-for-age z-scores will be calculated using standard WHO criteria. Stunting will be defined as having a height-for-age z-score < -2. The difference in the prevalence of stunting between children in the intervention and comparison areas will be determined.
measure: Cognitive function
time frame: End line (after one year); Amendment: BSID-III at year two (extension) endline
description: Study children will be assessed at end line using the INTERGROWTH 21st century instrument. Scores will be standardized within the study sample for analysis. Scores of children in intervention health zones will be compared with children in comparison areas to determine differences.
Amendment: at year two (extension) endline, children are assessed using the Bayley Scale for Infant and Toddler Development (BSID-III). Scores are standardized within the study sample for analysis.
measure: Measles vaccine 2nd dose
time frame: End line (one year)
description: We will collect data on whether study children have received a second dose of measles vaccine; Zambian Ministry of Health guidelines indicate that a second dose should be given to all children at age 15 months.
measure: Treatment of severe acute malnutrition (SAM)
time frame: Baseline and end line (one year)
description: Caregivers will be asked to report on whether a child received treatment for SAM at a health center.
measure: Caregiver awareness of child development
time frame: Baseline and end line (one year)
description: Caregivers will be asked at baseline and end line about their child's nutritional and developmental status, and their responses will be compared to objective measures (e.g., stunting, INTERGROWTH z-score).
arm group label: Early Childhood Development Program
arm group type: Experimental
description: Treatment clusters will be assigned a trained Child Development Agent (CDA) who will have four main tasks and responsibilities: 1) biweekly screening and management (including referral) of acute malnutrition in children; 2) encouragement of caregivers to utilize routine care services for children; 3) screening for symptoms of acute diseases including malaria, diarrhea, and pneumonia and referral for diagnosis and treatment; and 4) organization and mentoring of biweekly caregiver meetings to discuss parenting and promote early childhood cognitive stimulation.
Amendment: during second year extension, CDAs are responsible for organizing and mentoring biweekly (i.e., fortnightly) caregiver meetings. They no longer conduct household visits.
arm group label: Control
arm group type: No Intervention
description: Children residing in comparison health zones will only receive baseline and end line evaluations of their health and developmental status. There will be no active intervention in the comparison areas during the course of the study.
intervention type: Behavioral
intervention name: Early Childhood Development Program
description: A cadre of community-based health workers, Child Development Agents (CDAs), have four main tasks and responsibilities: 1) biweekly screening and management (including referral) of acute malnutrition in children; 2) encouragement of caregivers to utilize routine care services for children; 3) screening for symptoms of acute diseases and referral for diagnosis and treatment; and 4) organization and mentoring of weekly meetings for caregivers to discuss parenting issues and promote early childhood cognitive stimulation.
Amendment: during second year extension, CDAs are responsible for organizing and mentoring biweekly (i.e., fortnightly) caregiver meetings. They no longer conduct household visits.
arm group label: Early Childhood Development Program
criteria: 
gender: All
minimum age: 6 Months
maximum age: 12 Months
healthy volunteers: Accepts Healthy Volunteers
last name: Davidson Hamer
role: Principal Investigator
affiliation: Boston University
facility: 
facility: 
country: Zambia
responsible party type: Sponsor
mesh term: Growth Disorders