<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/NCT03281980</url>
  </required_header>
  <id_info>
    <org_study_id>PR-17009</org_study_id>
    <nct_id>NCT03281980</nct_id>
  </id_info>
  <brief_title>Effects of Psychosocial Stimulation and Cash on Children's Development and Behaviour</brief_title>
  <official_title>Effects of Adding Psychosocial Stimulation for Children of Lactating Mothers Enroled to Receive Unconditional Cash Transfer (UCT) and Health Education Awareness Programme on Children's Cognition and Behaviour in Rural 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: In developing countries, an estimated 219 million children do not reach their maximum&#xD;
      potentiality because of poverty and associated risk factors. More than half of the&#xD;
      Bangladeshi children &lt;5 years are at risk for developmental delay due to poverty and&#xD;
      sub-optimal home stimulation. Sometimes poor people become poorer due to catastrophic&#xD;
      expenditure on health care and fall into the vicious cycle of poverty&#xD;
&#xD;
      Knowledge gap: Although, there is evidence that conditional cash transfer helps develop poor&#xD;
      people' health and nutritional status, little is known about the effect of unconditional cash&#xD;
      transfer and health education (HE) programmes along with psychosocial stimulation on&#xD;
      children' cognition and behaviour.&#xD;
&#xD;
      Relevance: The study will bring an opportunity to evaluate the effect of transferring&#xD;
      unconditional cash and health education programme along with psychosocial stimulation to poor&#xD;
      families under safetynet programme of Bangladesh Govt. in rural areas. The study will also&#xD;
      document direct and indirect cost to measure cost effectiveness that will help in decision&#xD;
      making to implement the project if it shows benefits to children's development.&#xD;
&#xD;
      Primary Hypothesis (if any):&#xD;
&#xD;
        -  Unconditional cash transfer (UCT) and health education (HE) programme will improve&#xD;
           child's cognitive, motor and language development and behaviour compared to no&#xD;
           intervention group.&#xD;
&#xD;
        -  Adding psychosocial stimulation to an unconditional cash transfer (UCT) and health&#xD;
           education (HE) programme will will have an additive effect on Childs's cognitive, motor&#xD;
           and language development and behaviour compared to the control groups&#xD;
&#xD;
      Secondary Hypothesis:&#xD;
&#xD;
      Additionally the intervention will&#xD;
&#xD;
        -  be cost effective,&#xD;
&#xD;
        -  reduce mothers' depressive symptoms and improve their self esteem&#xD;
&#xD;
        -  improve children's growth and household food security status&#xD;
&#xD;
        -  reduce domestic violence&#xD;
&#xD;
        -  Health seeking behaviour and health care expenditure&#xD;
&#xD;
      Long-term goal: our ultimate goal is to find a suitable infrastructure to take to scale early&#xD;
      child development activities for the whole country.&#xD;
&#xD;
      Methods: It is a Cluster Randomized Controlled Trial with three-arms (i) UCT+HE+Psychosocial&#xD;
      stimulation (ii) UCT+HE and iii) Comparison group.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Primary objectives:&#xD;
&#xD;
      To evaluate the effect of UCT and HE programme on children's cognitive, motor and language&#xD;
      development and behaviour To evaluate the effect of adding psycho social stimulation to an&#xD;
      UCT and HE program on cognitive development and behavior of young children&#xD;
&#xD;
      Secondary objectives are:&#xD;
&#xD;
      To measure effect of the program on:&#xD;
&#xD;
      cost effectiveness of the intervention mothers'mental health (depression symptoms) and their&#xD;
      self esteem household food security status and children's growth and domestic violence health&#xD;
      care expenditure and health seeking behaviour of the families&#xD;
&#xD;
      Introduction:&#xD;
&#xD;
      In developing countries, an estimated 250 million children younger than 5 years in low and&#xD;
      middle income countries do not reach their maximum potentiality because of poverty and&#xD;
      associated risk factors. More than half of the Bangladeshi children less than 5 years are at&#xD;
      risk for developmental delay due to poverty and sub-optimal home stimulation. Sometimes poor&#xD;
      people become poorer due to catastrophic expenditure on health care and fall into the vicious&#xD;
      cycle of poverty. Conditional and unconditional cash transfer to the poor mothers has proved&#xD;
      a way of reducing poverty and improving health outcomes for mothers and children worldwide.&#xD;
      Ministry of Women and Children Affairs (MoWCA),Government of Bangladesh (GoB) introduced&#xD;
      maternity allowance in the fiscal year 2007-2008. This is an unconditional cash transfer&#xD;
      under safety net program for the poor mothers. The mothers also receive health education&#xD;
      awareness program. The overall objective of the cash and health education training program is&#xD;
      to ensure safety net in terms of morbidity, mortality and welfare during pregnancy and&#xD;
      lactation period for both mother and child. Adding psycho social stimulation to the program&#xD;
      will benefit children's cognition, behavior and nutritional status. On the other hand the&#xD;
      interventions together will address family's food security and mothers' physical and mental&#xD;
      health and self esteem because receiving extra cash as well as education on health and psycho&#xD;
      social stimulation will enhance mothers' capacity in many aspects.&#xD;
&#xD;
      Psycho social stimulation alone and along with other health and nutrition programs was found&#xD;
      to be effective for children's cognition and behavior [9-13]. Conditional Cash Transfer (CCT)&#xD;
      alone was also found significantly effective for child development in Mexico. On the other&#xD;
      hand, studies reported that UCT improved other health outcomes and nutrition, but little is&#xD;
      known about the effect of unconditional cash transfer (UCT) along with health education&#xD;
      program and psycho social stimulation on children's cognition and behavior. MoWCA is&#xD;
      transferring cash to poor pregnant mothers along with health education training program under&#xD;
      social safety net program. The present study group plan to conduct a randomized controlled&#xD;
      trial to document effect of adding psycho social stimulation to the present program on&#xD;
      children's cognition and behavior. 200 mother-child dyads in each arm will be enrolled when&#xD;
      their child is 6-16 months old. The participants of the intervention group will receive&#xD;
      psycho social stimulation fortnightly at home for 12 months.&#xD;
&#xD;
      However, UCT and HE program is a social safety net program under the ministry of Women and&#xD;
      Children Affairs of Bangladesh Government. The outcomes of this program are primarily&#xD;
      maternal and child health and does not directly focus on children's cognition and behavior.&#xD;
      However, social safety net programs may indirectly affect other outcomes like maternal&#xD;
      depressive symptom, violence against women, children's well being, cognition and behavior and&#xD;
      nutrition status for both mother and child. The researchers intend to add psycho social&#xD;
      stimulation in order to trigger the outcomes in terms of children's development. But the&#xD;
      program needs to be cost effective to be scale able in low resources settings. If the&#xD;
      intervention is cost effective, the package may be found attractive by respective policy&#xD;
      makers to improve development of poor children in those settings.&#xD;
&#xD;
      The maternity allowance of taka 500 ($6.25) per month is distributed through commercial&#xD;
      banking system. Health education awareness program is conducted monthly by some Local Non&#xD;
      Government Organizations (LNGOs) and Community Based Organizations (CBOs) on a wide range of&#xD;
      health and social welfare issues. The NGO,/CBOs have their own curriculum approved by MoWCA&#xD;
      for the awareness program. The Local government and community leaders can play an important&#xD;
      role in encouraging the eligible women to participate in the program. Home based psycho&#xD;
      social stimulation will be provided by community female Play leaders having at least 12 years&#xD;
      of education. So the project will build capacity of the community including the Play Leaders&#xD;
      from the community.&#xD;
&#xD;
      Study design:&#xD;
&#xD;
      This is a cluster randomized controlled trial with 3 arms: i) Psychosocial stimulation+&#xD;
      Health education program + Unconditional cash transfer ii) Health education program +&#xD;
      Unconditional cash transfer and iii) Comparison arm. The comparison group will consist of&#xD;
      those who are eligible to receive UCT but do not receive it due to resource constraints of&#xD;
      the UCT programme.&#xD;
&#xD;
      Recruitment:&#xD;
&#xD;
      11 Unions have been selected randomly out of 14 Union at Ullapara, a sub district under&#xD;
      Sirajgonj district in Bangladesh.The old Ward of a Union would be considered as cluster.&#xD;
&#xD;
      Since the Government is providing UCT to 79 mothers in each Union, the research team assume&#xD;
      to get approximately 26 participants in each Ward. 18 participants will be enrolled randomly&#xD;
      from each cluster. Restricted randomization process will be followed. There are three old&#xD;
      Wards in each Union. the each old ward (cluster) will be allocated for each arm randomly.&#xD;
&#xD;
      For comparison arm, mother-child dyads will be enrolled from any part of the old Ward until&#xD;
      the required sample size are fulfilled.The eligibility criteria of participants for the&#xD;
      comparison arm would be the same as that for the UCT recipients.&#xD;
&#xD;
      Intervention and Project Execution Plan:&#xD;
&#xD;
      The study aims to integrate three distinct interventions: i) Maternity allowance ii) Health&#xD;
      education awareness program and iii) Psychosocial stimulation.&#xD;
&#xD;
      i) Maternity Allowance: MoWCA, GoB provides maternity allowance of taka 500 ($6.25) for each&#xD;
      poor pregnant mother up to two years through banking channel under safety net program of the&#xD;
      GoB.&#xD;
&#xD;
      ii) Health Education Awareness Program: All mothers receiving maternity allowance receive&#xD;
      various health education training by designated LNGOs/CBOs through MoWCA, GoB funding.&#xD;
&#xD;
      iii) Psychosocial stimulation: The participants will receive fortnightly sessions of&#xD;
      psychosocial stimulation at home by community female play leaders for one year. The&#xD;
      curriculum of stimulation is based on improving the mother-child interaction, and providing&#xD;
      developmentally appropriate activities for the child. The curriculum has already been used in&#xD;
      several projects in Bangladesh run by Child Development Unit of icddr,b and has shown&#xD;
      significant benefits to children's development[10-12, 22] and growth[11, 22].&#xD;
&#xD;
      Training:&#xD;
&#xD;
      When the inter observer reliability coefficient will be more than 0.8 through data collection&#xD;
      training, will be considered that the trainee to be eligible to take part in the test&#xD;
      procedure. Quality of data collection will be checked at the field by supervisors/master&#xD;
      trainers on 10% of the assessments.&#xD;
&#xD;
      Data collection:&#xD;
&#xD;
      All data will be collected from all groups- Group I: UCT+HE Group II: (UCT+HE)+ Psychosocial&#xD;
      stimulation and group III: Comparison. Data will be collected at baseline, end line and some&#xD;
      others monthly to compare the outcome between the groups.&#xD;
&#xD;
      Data Storage Data will be stored in databases saved on icddr,b servers.The databases will be&#xD;
      password protected and only members of the study team and investigators will have access to&#xD;
      the password.&#xD;
&#xD;
      Sample size The study requires 200 mother-child dyads in each arm with 11 clusters of 18&#xD;
      participants in each cluster. So in total we will have 600 participants, 33 cluster, 18&#xD;
      participants in each cluster considering 90% power, 5% level of significance, an intraclass&#xD;
      correlation (ICC) of 0.05 and an effect size of previous study.&#xD;
&#xD;
      Data analysis:&#xD;
&#xD;
      Data will be checked for normality. Appropriate measures will be taken if there are any&#xD;
      abnormal distributions. Differences between groups in socioeconomic and other background&#xD;
      characteristics will be analyzed using t-test for continuous variables for two groups and a&#xD;
      ANOVAforthree groups. Effect of the interventions will also be measured using&#xD;
      intention-to-treat analysis controlling for the clustering effect.&#xD;
&#xD;
      .&#xD;
&#xD;
      Cost-effectiveness Analysis:&#xD;
&#xD;
      The objective of the study is to estimate the resources used and costs associated with&#xD;
      interventions. The research team will measure direct and indirect cost of for all the groups.&#xD;
      Average costs per participants will be calculated by multiplying the cost of resource items&#xD;
      by their respective unit costs. The outcomes of the study will be measured. Then the&#xD;
      incremental cost-effectiveness ratio (ICER) will be used in cost-effectiveness analysis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">August 20, 2017</start_date>
  <completion_date type="Anticipated">November 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">November 30, 2021</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>Other</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>The testers of the participants will not have the information about type of intervention of the children</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Child development composite score</measure>
    <time_frame>Change children's cognition, language and motor as composite score after one year intervention</time_frame>
    <description>Children's cognition, language and motor as composite score</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Children's behavior and composite score</measure>
    <time_frame>Change children's behaviour after one year intervention</time_frame>
    <description>Children's behavior will be measured by Wolk's behavior rating scale during bayley</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 by 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 by centimeter</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 by 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' 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)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mothers' level of self-esteem</measure>
    <time_frame>Change mother's level of self esteem after one year intervention</time_frame>
    <description>Mothers' level of self-esteem will be measured by Rosenberg Self-esteem 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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Family's monthly health seeking behavior</measure>
    <time_frame>Change family's health seeking behaviour status after one year intervention</time_frame>
    <description>Family's monthly health seeking behavior status will be measured by questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Family's monthly 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>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Family's monthly expenditure</measure>
    <time_frame>Change family's expenditure status after one year intervention</time_frame>
    <description>Family's monthly expenditure status will be measured by questionnaire</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</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">600</enrollment>
  <condition>Child Development</condition>
  <condition>Child Behavior</condition>
  <arm_group>
    <arm_group_label>Intervention (UCT+HE+PS)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The participants of this arm will receive UCT and HE along with psychosocial stimulation (PS)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Government Intervention (UCT+HE)</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>The participants of this arm will receive only UCT and HE</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Comparison</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Psychosocial stimulation (PS)</intervention_name>
    <description>i) Unconditional Cash Transfer(UCT)/ Maternity Allowance: MoWCA, GoB provides maternity allowance of taka 500 ($6.25) for each mother up to two years in each month.&#xD;
ii) Health Education Awareness Program: All mothers receive health education training by designated LNGOs/CBOs&#xD;
iii) Psychosocial stimulation: The participants will receive fortnightly sessions at home.</description>
    <arm_group_label>Intervention (UCT+HE+PS)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Government Intervention (UCT+HE)</intervention_name>
    <description>fgbfgjhgykghilk</description>
    <arm_group_label>Government Intervention (UCT+HE)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Mothers with a child aged 6-16 months&#xD;
&#xD;
          -  Eligible to receive UCT.&#xD;
&#xD;
               -  UCT+HE+PS arm: Receiving unconditional cash from government&#xD;
&#xD;
               -  UCT+HE arm: Receiving unconditional cash from government&#xD;
&#xD;
               -  Comparison arm: eligible to receive UCT but not under UCT programme.&#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&#xD;
&#xD;
          -  Developmental disorder or severe developmental delay&#xD;
&#xD;
          -  Not possible to test the child due to physical or behavioral 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>
  <location>
    <facility>
      <name>Upazilla</name>
      <address>
        <city>Sirajganj</city>
        <zip>6761</zip>
        <country>Bangladesh</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Bangladesh</country>
  </location_countries>
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    <PMID>23616511</PMID>
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  <verification_date>February 2021</verification_date>
  <study_first_submitted>August 17, 2017</study_first_submitted>
  <study_first_submitted_qc>September 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 13, 2017</study_first_posted>
  <last_update_submitted>March 29, 2021</last_update_submitted>
  <last_update_submitted_qc>March 29, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 30, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Bangladesh</keyword>
  <keyword>Child development</keyword>
  <keyword>Poor mothers</keyword>
  <keyword>Psycho social stimulation</keyword>
  <keyword>Unconditional cash transfer</keyword>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Undecided</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/NCT03281980
org study id: PR-17009
nct id: NCT03281980
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Burden: In developing countries, an estimated 219 million children do not reach their maximum
      potentiality because of poverty and associated risk factors. More than half of the
      Bangladeshi children <5 years are at risk for developmental delay due to poverty and
      sub-optimal home stimulation. Sometimes poor people become poorer due to catastrophic
      expenditure on health care and fall into the vicious cycle of poverty

      Knowledge gap: Although, there is evidence that conditional cash transfer helps develop poor
      people' health and nutritional status, little is known about the effect of unconditional cash
      transfer and health education (HE) programmes along with psychosocial stimulation on
      children' cognition and behaviour.

      Relevance: The study will bring an opportunity to evaluate the effect of transferring
      unconditional cash and health education programme along with psychosocial stimulation to poor
      families under safetynet programme of Bangladesh Govt. in rural areas. The study will also
      document direct and indirect cost to measure cost effectiveness that will help in decision
      making to implement the project if it shows benefits to children's development.

      Primary Hypothesis (if any):

        -  Unconditional cash transfer (UCT) and health education (HE) programme will improve
           child's cognitive, motor and language development and behaviour compared to no
           intervention group.

        -  Adding psychosocial stimulation to an unconditional cash transfer (UCT) and health
           education (HE) programme will will have an additive effect on Childs's cognitive, motor
           and language development and behaviour compared to the control groups

      Secondary Hypothesis:

      Additionally the intervention will

        -  be cost effective,

        -  reduce mothers' depressive symptoms and improve their self esteem

        -  improve children's growth and household food security status

        -  reduce domestic violence

        -  Health seeking behaviour and health care expenditure

      Long-term goal: our ultimate goal is to find a suitable infrastructure to take to scale early
      child development activities for the whole country.

      Methods: It is a Cluster Randomized Controlled Trial with three-arms (i) UCT+HE+Psychosocial
      stimulation (ii) UCT+HE and iii) Comparison group.
Primary objectives:

      To evaluate the effect of UCT and HE programme on children's cognitive, motor and language
      development and behaviour To evaluate the effect of adding psycho social stimulation to an
      UCT and HE program on cognitive development and behavior of young children

      Secondary objectives are:

      To measure effect of the program on:

      cost effectiveness of the intervention mothers'mental health (depression symptoms) and their
      self esteem household food security status and children's growth and domestic violence health
      care expenditure and health seeking behaviour of the families

      Introduction:

      In developing countries, an estimated 250 million children younger than 5 years in low and
      middle income countries do not reach their maximum potentiality because of poverty and
      associated risk factors. More than half of the Bangladeshi children less than 5 years are at
      risk for developmental delay due to poverty and sub-optimal home stimulation. Sometimes poor
      people become poorer due to catastrophic expenditure on health care and fall into the vicious
      cycle of poverty. Conditional and unconditional cash transfer to the poor mothers has proved
      a way of reducing poverty and improving health outcomes for mothers and children worldwide.
      Ministry of Women and Children Affairs (MoWCA),Government of Bangladesh (GoB) introduced
      maternity allowance in the fiscal year 2007-2008. This is an unconditional cash transfer
      under safety net program for the poor mothers. The mothers also receive health education
      awareness program. The overall objective of the cash and health education training program is
      to ensure safety net in terms of morbidity, mortality and welfare during pregnancy and
      lactation period for both mother and child. Adding psycho social stimulation to the program
      will benefit children's cognition, behavior and nutritional status. On the other hand the
      interventions together will address family's food security and mothers' physical and mental
      health and self esteem because receiving extra cash as well as education on health and psycho
      social stimulation will enhance mothers' capacity in many aspects.

      Psycho social stimulation alone and along with other health and nutrition programs was found
      to be effective for children's cognition and behavior [9-13]. Conditional Cash Transfer (CCT)
      alone was also found significantly effective for child development in Mexico. On the other
      hand, studies reported that UCT improved other health outcomes and nutrition, but little is
      known about the effect of unconditional cash transfer (UCT) along with health education
      program and psycho social stimulation on children's cognition and behavior. MoWCA is
      transferring cash to poor pregnant mothers along with health education training program under
      social safety net program. The present study group plan to conduct a randomized controlled
      trial to document effect of adding psycho social stimulation to the present program on
      children's cognition and behavior. 200 mother-child dyads in each arm will be enrolled when
      their child is 6-16 months old. The participants of the intervention group will receive
      psycho social stimulation fortnightly at home for 12 months.

      However, UCT and HE program is a social safety net program under the ministry of Women and
      Children Affairs of Bangladesh Government. The outcomes of this program are primarily
      maternal and child health and does not directly focus on children's cognition and behavior.
      However, social safety net programs may indirectly affect other outcomes like maternal
      depressive symptom, violence against women, children's well being, cognition and behavior and
      nutrition status for both mother and child. The researchers intend to add psycho social
      stimulation in order to trigger the outcomes in terms of children's development. But the
      program needs to be cost effective to be scale able in low resources settings. If the
      intervention is cost effective, the package may be found attractive by respective policy
      makers to improve development of poor children in those settings.

      The maternity allowance of taka 500 ($6.25) per month is distributed through commercial
      banking system. Health education awareness program is conducted monthly by some Local Non
      Government Organizations (LNGOs) and Community Based Organizations (CBOs) on a wide range of
      health and social welfare issues. The NGO,/CBOs have their own curriculum approved by MoWCA
      for the awareness program. The Local government and community leaders can play an important
      role in encouraging the eligible women to participate in the program. Home based psycho
      social stimulation will be provided by community female Play leaders having at least 12 years
      of education. So the project will build capacity of the community including the Play Leaders
      from the community.

      Study design:

      This is a cluster randomized controlled trial with 3 arms: i) Psychosocial stimulation+
      Health education program + Unconditional cash transfer ii) Health education program +
      Unconditional cash transfer and iii) Comparison arm. The comparison group will consist of
      those who are eligible to receive UCT but do not receive it due to resource constraints of
      the UCT programme.

      Recruitment:

      11 Unions have been selected randomly out of 14 Union at Ullapara, a sub district under
      Sirajgonj district in Bangladesh.The old Ward of a Union would be considered as cluster.

      Since the Government is providing UCT to 79 mothers in each Union, the research team assume
      to get approximately 26 participants in each Ward. 18 participants will be enrolled randomly
      from each cluster. Restricted randomization process will be followed. There are three old
      Wards in each Union. the each old ward (cluster) will be allocated for each arm randomly.

      For comparison arm, mother-child dyads will be enrolled from any part of the old Ward until
      the required sample size are fulfilled.The eligibility criteria of participants for the
      comparison arm would be the same as that for the UCT recipients.

      Intervention and Project Execution Plan:

      The study aims to integrate three distinct interventions: i) Maternity allowance ii) Health
      education awareness program and iii) Psychosocial stimulation.

      i) Maternity Allowance: MoWCA, GoB provides maternity allowance of taka 500 ($6.25) for each
      poor pregnant mother up to two years through banking channel under safety net program of the
      GoB.

      ii) Health Education Awareness Program: All mothers receiving maternity allowance receive
      various health education training by designated LNGOs/CBOs through MoWCA, GoB funding.

      iii) Psychosocial stimulation: The participants will receive fortnightly sessions of
      psychosocial stimulation at home by community female play leaders for one year. The
      curriculum of stimulation is based on improving the mother-child interaction, and providing
      developmentally appropriate activities for the child. The curriculum has already been used in
      several projects in Bangladesh run by Child Development Unit of icddr,b and has shown
      significant benefits to children's development[10-12, 22] and growth[11, 22].

      Training:

      When the inter observer reliability coefficient will be more than 0.8 through data collection
      training, will be considered that the trainee to be eligible to take part in the test
      procedure. Quality of data collection will be checked at the field by supervisors/master
      trainers on 10% of the assessments.

      Data collection:

      All data will be collected from all groups- Group I: UCT+HE Group II: (UCT+HE)+ Psychosocial
      stimulation and group III: Comparison. Data will be collected at baseline, end line and some
      others monthly to compare the outcome between the groups.

      Data Storage Data will be stored in databases saved on icddr,b servers.The databases will be
      password protected and only members of the study team and investigators will have access to
      the password.

      Sample size The study requires 200 mother-child dyads in each arm with 11 clusters of 18
      participants in each cluster. So in total we will have 600 participants, 33 cluster, 18
      participants in each cluster considering 90% power, 5% level of significance, an intraclass
      correlation (ICC) of 0.05 and an effect size of previous study.

      Data analysis:

      Data will be checked for normality. Appropriate measures will be taken if there are any
      abnormal distributions. Differences between groups in socioeconomic and other background
      characteristics will be analyzed using t-test for continuous variables for two groups and a
      ANOVAforthree groups. Effect of the interventions will also be measured using
      intention-to-treat analysis controlling for the clustering effect.

      .

      Cost-effectiveness Analysis:

      The objective of the study is to estimate the resources used and costs associated with
      interventions. The research team will measure direct and indirect cost of for all the groups.
      Average costs per participants will be calculated by multiplying the cost of resource items
      by their respective unit costs. The outcomes of the study will be measured. Then the
      incremental cost-effectiveness ratio (ICER) will be used in cost-effectiveness analysis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Outcomes Assessor)
masking description: The testers of the participants will not have the information about type of intervention of the children
measure: Child development composite score
time frame: Change children's cognition, language and motor as composite score after one year intervention
description: Children's cognition, language and motor as composite score
measure: Children's behavior and composite score
time frame: Change children's behaviour after one year intervention
description: Children's behavior will be measured by Wolk's behavior rating scale during bayley
measure: Children's weight
time frame: Change children's weight after one year intervention
description: Children's weight will be measured by Gram
measure: Children's height
time frame: Change children's height after one year intervention
description: Children's height will be measured by centimeter
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 by Gram
measure: Mothers' height
time frame: Change mother's height after one year intervention
description: Mothers' height 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)
measure: Mothers' level of self-esteem
time frame: Change mother's level of self esteem after one year intervention
description: Mothers' level of self-esteem will be measured by Rosenberg Self-esteem 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
measure: Family's monthly health seeking behavior
time frame: Change family's health seeking behaviour status after one year intervention
description: Family's monthly health seeking behavior status will be measured by questionnaire
measure: Family's monthly 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 monthly expenditure
time frame: Change family's expenditure status after one year intervention
description: Family's monthly expenditure status will be measured by questionnaire
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
arm group label: Intervention (UCT+HE+PS)
arm group type: Experimental
description: The participants of this arm will receive UCT and HE along with psychosocial stimulation (PS)
arm group label: Government Intervention (UCT+HE)
arm group type: Sham Comparator
description: The participants of this arm will receive only UCT and HE
arm group label: Comparison
arm group type: No Intervention
intervention type: Other
intervention name: Psychosocial stimulation (PS)
description: i) Unconditional Cash Transfer(UCT)/ Maternity Allowance: MoWCA, GoB provides maternity allowance of taka 500 ($6.25) for each mother up to two years in each month.
ii) Health Education Awareness Program: All mothers receive health education training by designated LNGOs/CBOs
iii) Psychosocial stimulation: The participants will receive fortnightly sessions at home.
arm group label: Intervention (UCT+HE+PS)
intervention type: Other
intervention name: Government Intervention (UCT+HE)
description: fgbfgjhgykghilk
arm group label: Government Intervention (UCT+HE)
criteria: 
gender: All
minimum age: 6 Months
maximum age: 16 Months
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Bangladesh
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PMID: 17046468
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PMID: 18328930
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PMID: 1676083
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responsible party type: Sponsor
sharing ipd: Undecided
ipd description: Undecided