<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/NCT03031236</url>
  </required_header>
  <id_info>
    <org_study_id>PR-15002</org_study_id>
    <nct_id>NCT03031236</nct_id>
  </id_info>
  <brief_title>Reduce Childhood Maltreatment and Promote Development</brief_title>
  <official_title>Effect of Integrated Management of Childhood Maltreatment, Maternal Depression, Psychosocial Stimulation and Nutritional Intervention on Child Development - A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>International Centre for Diarrhoeal Disease Research, Bangladesh</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>UBS Optimus Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>International Centre for Diarrhoeal Disease Research, Bangladesh</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background (brief):&#xD;
&#xD;
        1. Burden: The uniqueness of each child is tremendously influenced by interaction between&#xD;
           nature and nurture during critical period of brain development that promotes foundation&#xD;
           of brain architecture through neuronal connections.&#xD;
&#xD;
        2. Knowledge gap: Young children in Bangladesh are prone to multiple physiological and&#xD;
           psycho-social risk factors e.g. poverty, maltreatment, malnutrition, disease, parental&#xD;
           illiteracy, maternal depression and lack of stimulation, all of which are preventable.&#xD;
           Little is reported about any comprehensive package of development that addresses most of&#xD;
           these early childhood risks and promotes optimum early childhood development (ECD).&#xD;
&#xD;
        3. Relevance: The aim of this study is to develop and evaluate an integrated, low cost, and&#xD;
           feasible center based approach that focuses on positive parenting of children during&#xD;
           early life that will promote early stimulation, minimize childhood maltreatment, boost&#xD;
           up of maternal self-esteem and healthy thinking and improve health and nutritional (HN)&#xD;
           status of children.&#xD;
&#xD;
      Hypothesis (if any):&#xD;
&#xD;
      This integrated intervention will promote maternal child-care practices and mental health&#xD;
      that will finally improve their children's growth, micro-nutrient status, early brain&#xD;
      development compared to control group.&#xD;
&#xD;
      Objectives:&#xD;
&#xD;
      To see the effect of an integrated intervention (ECD + HN) on growth, micro-nutrient status,&#xD;
      child development along with effect on maternal child-care practices and mental health.&#xD;
&#xD;
      Methods:&#xD;
&#xD;
      Randomly selected 2 groups will be identified as intervention and control (150 mothers'&#xD;
      from15 clusters in each group). Mothers of 8-23 months old children living in slums and&#xD;
      practice harsh child-disciplining will be identified as study population. The mothers of&#xD;
      intervention (ECD+HN) group will receive fortnightly group sessions for 11 months that will&#xD;
      include combined messages on a) psycho-social stimulation, b) positive parenting to prevent&#xD;
      child maltreatment and c) cognitive behavioral therapy (CBT) for positive thinking, d) health&#xD;
      and nutrition messages and e) 15 micro-nutrient sprinkle supplement.(90 sachets of over 6&#xD;
      month-period). The control group will only receive the usual health messages provided by the&#xD;
      government.&#xD;
&#xD;
      Outcome measures/variables:&#xD;
&#xD;
        -  Children's cognitive, motor, language and socio-emotional development; anthropometry;&#xD;
           hemoglobin and micro-nutrient status (serum vitamin B12, iron and folic acid)&#xD;
&#xD;
        -  Mother s' parenting practices, depressive symptoms, self-esteem and child-maltreatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hypothesis to be tested:&#xD;
&#xD;
      This integrated intervention will a) improve children's growth, hemoglobin, micro-nutrient&#xD;
      status (vitamin B12 and folic acid), cognitive, motor, language and social-emotional&#xD;
      development, b) minimize maltreatment of children by parents, c) improve positive parenting&#xD;
      and d) reduce mothers' stress and depressive symptoms compared to control group.&#xD;
&#xD;
      Objectives:&#xD;
&#xD;
      Primary: This integrated intervention will&#xD;
&#xD;
        -  Improve cognitive, motor, language and social-emotional development of children&#xD;
&#xD;
        -  Minimize maltreatment of children by the caregivers&#xD;
&#xD;
      Secondary: This integrated intervention will bring following benefits in intervention group&#xD;
      compared to control group- On children-&#xD;
&#xD;
        -  Improve height, weight and head circumference&#xD;
&#xD;
        -  Improve hemoglobin, vitamin B12 and folic acid status, On mothers (primary caregivers)&#xD;
&#xD;
        -  Reduce mothers' stress and depressive symptoms&#xD;
&#xD;
        -  Improve positive parenting practices&#xD;
&#xD;
      Background of the Project including Preliminary Observations:&#xD;
&#xD;
      The rate of global acute malnutrition is 16% while the rate of stunting in Bangladesh is as&#xD;
      high as 41% in &lt;five yrs children. Moreover, the children in Bangladesh are either deficient&#xD;
      in different micro-nutrients like iron 10.7% and iodine 34% or have inadequate&#xD;
      micro-nutrients in their diets like vitamin B12 and folate which is less than 50%. Many&#xD;
      children in developing countries fail to reach their developmental potential due to lack of&#xD;
      cognitive stimulation and Bangladeshi children have limited access to play materials and&#xD;
      activities.&#xD;
&#xD;
      According to Walker and colleagues 300 million children are exposed to violence globally. Our&#xD;
      unpublished data show that 32% of children &lt;2 years are subjected to maltreatment and harsh&#xD;
      punishment in Bangladesh.&#xD;
&#xD;
      Depression is one of the leading causes of disease burden for women and children of these&#xD;
      mothers may suffer from behavioral problems.. Depression is reported as a leading cause of&#xD;
      disease burden for women aged 15-44 years in all countries. The South Asia has the least&#xD;
      woman-friendly societies in the world. Maternal depression is becoming a major public health&#xD;
      problem in these societies, partly due to gender roles and practices and partly to poverty.&#xD;
      Depression indicates state of mind that causes symptoms like crying spells, sleeping&#xD;
      problems, depressed mood, irritability, fatigue, anxiety, poor concentration and&#xD;
      interpersonal hypersensitivity, and these can range from mild to severe in nature. Maternal&#xD;
      depression not only affects mothers' health, evidenced by poorer nutrition, higher suicide&#xD;
      attempts and self harm but also results in poor health and developmental outcomes of their&#xD;
      children.&#xD;
&#xD;
      In Bangladesh prevalence of anxiety and depressive symptoms are as high as 18-33% and we&#xD;
      found a significant association with child maltreatment in an urban community on). Rahman et&#xD;
      al. tested an innovative model of community-based management of depression using Cognitive&#xD;
      Behavioral Therapy (CBT) in Pakistan and reported improvement in maternal depression 6 months&#xD;
      postpartum. Considering similar family structure, religion and culture between Bangladesh and&#xD;
      Pakistan, it is likely that the program will work in Bangladesh too.&#xD;
&#xD;
      Despite prevalent child maltreatment in Bangladesh, there are very few interventions to&#xD;
      reduce maltreatment and those for children under 5 yrs of age are even rarer. Similarly,&#xD;
      though attention has been diverted to ECD for several years now, very few of those programs&#xD;
      address children under 3 yrs of age. Study design would probably be the 1st intervention&#xD;
      using a robust research method to test the efficacy of an integrated method to address ECD,&#xD;
      child maltreatment as well as health and nutrition of young children. Investigators will&#xD;
      modify existing curriculum to further focus on child maltreatment. Investigators have&#xD;
      targeted poor families from urban slums who are deprived of such services but face most of&#xD;
      the risk factors and hope to improve their families' condition using low-cost intervention.&#xD;
      Researchers have targeted the mothers as study participants who also primary caregiver of a&#xD;
      child especially at younger age and have a major role in the child development. Mothers are&#xD;
      also more vulnerable for depression than the fathers in Bangladeshi culture.&#xD;
&#xD;
      In addition, there is no culturally appropriate tool to assess child maltreatment in&#xD;
      Bangladesh. In this project researchers attempt to modify or adapt existing instruments or if&#xD;
      needed develop new tools suitable for use in Bangladesh.&#xD;
&#xD;
      Research Design and Methods&#xD;
&#xD;
      Population and sample size:&#xD;
&#xD;
      This study will be conducted in the semi-urban area (preferably in Kamalapur) of Dhaka,&#xD;
      Bangladesh. Total sample is 10 mother-child duos in randomly selected 30 clusters ( n=300),&#xD;
      half of which (n=150) will be beneficiaries from the intervention.&#xD;
&#xD;
      Plan of work: The intervention package will be piloted in the non study community for its&#xD;
      feasibility and will be modified accordingly. The selected mother-child duos will be invited&#xD;
      to field office for baseline assessments. Intervention group will be invited to join the&#xD;
      center-based group sessions fortnightly for one year, the control group will receive existing&#xD;
      government health messages. Both the groups will receive free health service from study&#xD;
      medical officer for acute illnesses. After a year, final assessments will be done in both the&#xD;
      groups. At baseline and end line mother-child interaction will be observed in a sub-sample of&#xD;
      the population.&#xD;
&#xD;
      Procedures:&#xD;
&#xD;
      It will be a cluster-randomized trial. Clusters will be formed based on number of household&#xD;
      members (those using the same cooking pot) as well as geographical boundary. On average there&#xD;
      will be 150-200 households in each cluster, but there may be some variation in household&#xD;
      numbers per cluster and per stratum.Total sample will be 10 mother-child duos in randomly&#xD;
      selected 30 clusters (n=300), half of which (n=150) will be beneficiaries from the&#xD;
      intervention.&#xD;
&#xD;
      Plan of work: The intervention package will be piloted in the non study community for its&#xD;
      feasibility and will be modified accordingly. The selected mother-child duos will be invited&#xD;
      to field office for baseline assessments. Intervention group will be invited to join the&#xD;
      center-based group sessions fortnightly for 1 year, the control group will receive existing&#xD;
      government health messages. Both the groups will receive free health service from study&#xD;
      medical officer for acute illnesses. After a year, final assessments will be done in both the&#xD;
      groups. At baseline and end line mother-child interaction will be observed in a sub-sample of&#xD;
      the population. At the beginning of the study, 4 Focus group discussions of (8-10 non-study&#xD;
      mothers) will be conducted in the community to know about the mothers' parenting practices.&#xD;
      At the middle of the study qualitative information (case report and 30 In-Depth Interviews)&#xD;
      will be collected form the intervened mothers about the intervention package they are&#xD;
      receiving. Intervened mothers will be interviewed at their home according to their time&#xD;
      availability. Key Informant's Interview (KII) will be conducted after a year from 2 play&#xD;
      leaders (who will deliver the intervention) and 2 supervisors (who will train the play&#xD;
      leaders and monitored them). Interviews will be taken and tape recorded with consent of the&#xD;
      participants.&#xD;
&#xD;
        1. Preparatory works: At the first phase researchers will select the site and also complete&#xD;
           the process of 'Ethical Review' of the project.&#xD;
&#xD;
           Screening and enrollment: After taking the consent, screening of mothers of 8 to 23&#xD;
           months old children, who practice harsh discipline will be conducted in 30 identified&#xD;
           clusters by trained health workers using ISPCAN Child Abuse Screening Tool-Parent&#xD;
           Version (ICAST-P). Researchers have already used the modified version of these tools in&#xD;
           Bangladesh. According to primary investigation there are 10% mothers having 8 to 23&#xD;
           months old children in study field site. With this estimation to get 10 eligible mothers&#xD;
           from each cluster researcher group have to screen 100 mothers. Mothers who will fulfill&#xD;
           the study enrollment criteria will be offered to join the study and will be invited to&#xD;
           the test centers for baseline assessments.&#xD;
&#xD;
           At the same time research group will start developing the study materials:&#xD;
&#xD;
           For intervention: Development and piloting of following manuals, that already exist and&#xD;
           needs further simplification and adaptations&#xD;
&#xD;
             -  Psycho-social stimulation for individual visits&#xD;
&#xD;
             -  Cognitive behavioral therapy For assessments: Cultural adaptation, Standard&#xD;
                Operating Procedures (SOPs) preparation and field testing of following tools&#xD;
&#xD;
             -  Bayley Scale of Infant and Toddler Development (Already adapted, we have to take&#xD;
                permission from Pearson's to use it)&#xD;
&#xD;
             -  Field testing and adaptation of ISPCAN Child Abuse Screening Tool -Parent Version&#xD;
                (ICAST-P)&#xD;
&#xD;
             -  Qualitative questionnaires&#xD;
&#xD;
             -  Observational tools&#xD;
&#xD;
           Tools that are adapted, tested and ready to use&#xD;
&#xD;
             -  Parenting questionnaire&#xD;
&#xD;
             -  Home observation for measurement of environment (HOME)&#xD;
&#xD;
             -  Rosenberg Self Esteem Scale&#xD;
&#xD;
             -  CES-D to measure depressive symptoms&#xD;
&#xD;
             -  Socio-economic status (SES) questionnaire&#xD;
&#xD;
             -  Wolke's Behavior Rating scale&#xD;
&#xD;
             -  Anthropometric measurements&#xD;
&#xD;
        2. Baseline assessment:&#xD;
&#xD;
           On children:&#xD;
&#xD;
           Bayley Scales of Infant and Toddler Development (Bayley-III) will be used to assess&#xD;
           cognitive, language and motor development of the children. The test has been used in&#xD;
           many developing countries, and has been the instrument of choice for much nutrition and&#xD;
           child development research at this age in other countries like Indonesia and Brazil. The&#xD;
           Bayley has often been sensitive to changes following interventions. Because the Bayley&#xD;
           has not been standardized in Bangladesh, researcher will not compare these children's&#xD;
           scores with the test norms or children of other countries. Study aim is only to compare&#xD;
           the development of groups of children within the same community. Bayley usually takes&#xD;
           about an hour to test the children.&#xD;
&#xD;
           The children's behavior during the Bayley tests will be rated on five 9-point scales&#xD;
           using a modified version of the scales developed by Wolke (1990). These ratings include&#xD;
           infants' activity (very still=1 to overactive=9), emotional tone (unhappy=1 to radiates&#xD;
           happiness=9), approach or responsiveness to examiner in the first 10 minutes&#xD;
           (avoiding=1to friendly and inviting=9), cooperation with test procedure (resists all&#xD;
           suggestions=1to always complies=9), and vocalization (very quiet=1to constant&#xD;
           vocalization=9). The scale has been used in several studies in Bangladesh and was&#xD;
           sensitive to intervention effects .&#xD;
&#xD;
           Anthropometry: Mother and child's anthropometric measurements (height and weight of&#xD;
           mothers; length/height, weight, MUAC and head circumference of children) will be&#xD;
           assessed at using standard procedures.&#xD;
&#xD;
           On mothers':&#xD;
&#xD;
           Maternal self esteem: This will be assessed using adapted version of the Rosenberg Self&#xD;
           Esteem Scale, the most widely used measure of self esteem for research purposes. It has&#xD;
           been used previously in Bangladesh by this research team and by others as a valid&#xD;
           instrument.&#xD;
&#xD;
           Information on child maltreatment and neglect: The International Society for the&#xD;
           Prevention of Child Abuse and Neglect (ISPCAN) has developed ISPCAN Child Abuse&#xD;
           Screening Tool- Parent Version (ICAST-P) that has been widely used in developing&#xD;
           countries, like India and Jamaica. This research group already used modified version of&#xD;
           this tool in Bangladesh on hospital mothers.&#xD;
&#xD;
           Measurement of maternal depressive symptoms will be done using Center for Epidemiologic&#xD;
           Studies Depression Scale (CES-D). This tool has been used in Bangladesh and South-East&#xD;
           Asian countries.&#xD;
&#xD;
           Quality of stimulation at home was assessed using Caldwell's Home Observation for&#xD;
           Measurement of Environment (HOME) which was modified for Bangladesh and was used in&#xD;
           other studies by the same research team.&#xD;
&#xD;
           Other measurements: These following measures will be collected as covariates -&#xD;
           Socioeconomic status: On enrollment information will be collected on the family's assets&#xD;
           (furniture e.g. bed/tables/chairs, electrical household equipment's e.g. radio/TV/fan,&#xD;
           farm animals, vehicles e.g. rickshaw/boat/bicycle/motorbike, etc.), housing condition&#xD;
           (type of roof, floor and walls), access to water and sanitation, electricity, crowding&#xD;
           condition, and parental education and occupation. An asset quintile will be created from&#xD;
           all available assets available at household level.&#xD;
&#xD;
           Observational tools: Structured observation checklist will be used to see mother-child&#xD;
           interaction Qualitative assessments will be used to conduct focus group discussion, in&#xD;
           depth interviews and case reports.&#xD;
&#xD;
        3. Intervention:&#xD;
&#xD;
      It will be a low cost intervention focusing on building awareness among population at risk&#xD;
      through hands on training delivered by trained health workers with minimum educational level&#xD;
      and low salary. Our previous experience shows that it is possible to train paraprofessionals&#xD;
      to provide intervention of this intensity. We have also shown that psycho-social stimulation&#xD;
      provided for 10 or 12 months can improve the development and behavior of children&#xD;
      significantly. Two weeks training and one week's field practice will be required to train&#xD;
      these staff. We will train the play leaders regarding the whole intervention package&#xD;
      including stimulation, Cognitive Behavioral Therapy, health and nutrition messages that&#xD;
      include infant and young child feeding practices, good hygiene practice, and positive&#xD;
      parenting messages (stimulation, learning through play, love and affection). There will be&#xD;
      one-hour sessions fortnightly for 11 months. Attending 2 sessions per month is feasible for&#xD;
      the mothers. This intervention will address the major risk factors e.g. negative parenting,&#xD;
      lack of stimulation, child maltreatment, malnutrition, maternal stress/depressive symptoms,&#xD;
      faulty care-seeking practices due to knowledge gap, etc. using a combined package.&#xD;
&#xD;
      There will be a combination of 3 types of interventions:&#xD;
&#xD;
      (i) Early stimulation and prevention of maltreatment through positive parenting, boosting up&#xD;
      of maternal self-esteem and stress management (ECD): Psycho-social stimulation intervention&#xD;
      will follow a set of culturally appropriate, semi-structured, child's age appropriate&#xD;
      curriculum. This integrated approach will be given in groups of mothers and child. During the&#xD;
      session the field-workers will show the mothers how to play with home-made toys and books and&#xD;
      interact with their children in a way to promote their development. Along with the&#xD;
      stimulation program, the field workers will also provide some advice regarding positive&#xD;
      parenting and boosting up maternal self esteem and stress management. Care will be taken to&#xD;
      appreciate mothers for their activities and positive reinforcement will be strongly&#xD;
      encouraged. The developmental activities will be conducted in a playful manner and not as a&#xD;
      work-oriented activity. The activities in the curriculum will be ordered by difficulty level&#xD;
      and the health workers will be trained to choose the level for each child according to their&#xD;
      ability to do the activities.&#xD;
&#xD;
      (ii) Health education and sprinkles supplementation (HN): The participants will receive&#xD;
      health and nutrition messages to improve children's health. In addition children will receive&#xD;
      multiple micro-nutrient powder (Vitamin A 400 µg, vitamin D 5 µg, vitamin E 5 mg, vitamin C&#xD;
      30 mg, thiamine 0.5 mg, riboflavin 0.5 mg, niacin 6 mg, pyridoxine 0.5 mg, vitamin B12 0.9&#xD;
      mg, folate 150 µg, iron 10 mg, zinc 4.1 mg, copper 0.56 mg, selenium 17.0 µg and iodine 90&#xD;
      µg) supplementation at household level (90 sachets of over 6 month-period).&#xD;
&#xD;
      (iii) Cognitive Behavioral Therapy: Intervention to help mothers change their negative&#xD;
      behaviour and to improve self care, child care, income generation activities, will follow the&#xD;
      &quot;Thinking Healthy Program&quot; model of Rahman and colleague using cognitive behavior therapy&#xD;
      (CBT). CBT will improve maternal behaviour leading to &quot;positive parenting&quot; and prevention of&#xD;
      maltreatment. Cognitive Behavioral Therapy is an &quot;evidence-based and structured form of&#xD;
      talking therapy that aims to alter the cycle of unhelpful or unhealthy thinking (cognition)&#xD;
      and the resulting undesirable actions (behavior).&quot; Cognitive Behavioral Therapy specifically&#xD;
      focused on &quot;changing thinking style toward positive&quot; and not associated with any medication.&#xD;
      CBT found to be effective in managing or treating not only depression, also a variety of&#xD;
      other conditions-e.g. mood, personality, stress, eating habit, tic etc.This approach with&#xD;
      rural mothers of similar context showed positive impact on child outcome in Pakistan, which&#xD;
      is culturally and economically similar to Bangladesh.&#xD;
&#xD;
      CBT is aimed to alter the cycle of negative thinking of people to positive direction. The&#xD;
      cycle of negative thoughts usually breaks in two ways by using Cognitive and Behavioral&#xD;
      aspect of the therapy -&#xD;
&#xD;
        -  Cognitive aspect of CBT: This focuses on altering ways of thinking of a person (mother)&#xD;
           that includes thoughts, beliefs, ideas, attitudes, assumptions, mental imagery, and ways&#xD;
           of directing her attention.&#xD;
&#xD;
        -  Behavioral aspect of CBT: This focuses on helping the mother to face the challenges and&#xD;
           the opportunities that facilitates child-raising with a sound and clear mind- and then&#xD;
           to take necessary actions that are likely to have desired outcomes.&#xD;
&#xD;
      This model is proven to be an effective approach in breaking the cycle of depression and&#xD;
      improving confidence, coping strategies and assertiveness in poor community with low resource&#xD;
      setting. The cycle is broken through two ways of CBT- cognitive aspect (directing attention&#xD;
      to positive direction) and behavioral aspect (helping to meet challenges).&#xD;
&#xD;
      d) Final assessment, data entry and data analysis: After 11 months of intervention, the&#xD;
      participants will be invited again in the centre for end line assessment. The same assessment&#xD;
      tools will be used as in the base line. Simultaneous data entry will continue in SPSS&#xD;
      software. After data cleaning, preliminary analysis will be done according to following plan.&#xD;
&#xD;
      All the baseline variables will be used to compare between lost and tested groups as well as&#xD;
      the intervention and control groups. The two time-point assessment will also provide&#xD;
      information about within group changes. Some variables e.g. HOME, mother-child interaction,&#xD;
      parenting, childcare etc. will be used either as mediator or as outcome in separate analyses&#xD;
&#xD;
      Outcome Variables:&#xD;
&#xD;
      On Mothers-&#xD;
&#xD;
        1. Maternal stress and depressive symptoms using CES-D at baseline and at the end.&#xD;
&#xD;
        2. Self Esteem assessment using Rosenberg Self Esteem Scale at baseline and at the end in&#xD;
           test centre&#xD;
&#xD;
        3. Information about child maltreatment by parents will be collected at baseline during&#xD;
           screening at home and at the end.&#xD;
&#xD;
        4. Home observation for measurement of environment (HOME) at household level, twice (at&#xD;
           baseline and at the end)&#xD;
&#xD;
      On Children-&#xD;
&#xD;
        1. Child's cognitive, motor and language assessment using Bayley-III and behavioral&#xD;
           assessment during test using Wolke's Behavior Rating Scale, at baseline and at the end&#xD;
           in test centre. Children will accompany their mothers to the centre. (45 min)&#xD;
&#xD;
        2. Children's Micronutrient status (vitamin B12 and folic acid) at baseline and at the end&#xD;
           in test centre&#xD;
&#xD;
        3. Children's Hemoglobin status&#xD;
&#xD;
        4. Children's height, weight, MUAC, head circumference at baseline and at the end&#xD;
&#xD;
      Covariates-&#xD;
&#xD;
        1. Socio-economic variables (asset index/ quintile)&#xD;
&#xD;
        2. Demographic variables (housing/ sanitation)&#xD;
&#xD;
        3. Maternal nutritional status (BMI)&#xD;
&#xD;
        4. Child's age and sex&#xD;
&#xD;
        5. Compliance on micro-nutrients and dietary recall&#xD;
&#xD;
        6. Morbidity Sample Size Calculation and Outcome (Primary and Secondary) Variable(s)&#xD;
&#xD;
      Considering 5% level of significance, 80% power, an improvement of 0.4 SD in children's&#xD;
      developmental outcome based on our previous experiences, an ICC of 0.01 and 30% drop outs, we&#xD;
      need to enroll 150 mother-child duos in each group as per equation below- 2(SD)2 n =&#xD;
      ---------------- X f (αβ) (M1-M2) 2&#xD;
&#xD;
      n: sample required, SD: 16 (based on previous data of Bayley Score) α: 5% level of&#xD;
      significance β: 80% power f= α*β M1-M2 = Difference = 6.4 points (based on previous studies)&#xD;
      So the calculated n=100&#xD;
&#xD;
      Considering the clustering we need to adjust this sample size by multiplying the above value&#xD;
      (100) by the design effect.&#xD;
&#xD;
      Design Effect = 1 + [(m-1) * ICC m corresponds to the average number of infants per cluster.&#xD;
      Assuming there are on average 10 mother-child duos/cluster.&#xD;
&#xD;
      Using ICC = 0.01, the design effect = 1 + [(10-1) * ICC = 1 + 0.9 = 1.09 Therefore new sample&#xD;
      size = 100*1.09= 109 per group , considering 30% drop-out the sample size per group is around&#xD;
      150 infants in stimulation group and 150 infants in control group.&#xD;
&#xD;
      Data Analysis&#xD;
&#xD;
      icddr,b scientists and co-investigators of this research project will analyze the data using&#xD;
      Stata/SPSS. All data will be checked for normality. Log transformation will be done if not&#xD;
      normally distributed. Indices will be created where it is required (eg: SES index, housing&#xD;
      index etc). Pearson's correlations will be conducted to examine the association between age&#xD;
      of the child and each developmental measure. A comparison will be done between the&#xD;
      socio-demographic characteristics of the intervened and control groups using t-test for&#xD;
      continuous variables and χ2 for categorical variables. Partial correlation will be used&#xD;
      controlling age and sex to examine association of different covariates with developmental&#xD;
      scores.&#xD;
&#xD;
      Finally, multi-level regression analyses will be done. In each regression analysis, the&#xD;
      outcome will be the final developmental score, with age at enrollment, the relevant initial&#xD;
      scores, and intervention as predictors. Again, comparison will be done between the treatment&#xD;
      effect in intervention and control groups. All variables that will be different between&#xD;
      intervention and control groups at baseline and will correlate with the developmental&#xD;
      outcomes and will address high co-linearity among the covariates in all analyses.&#xD;
&#xD;
      The main outcomes are children's cognitive, language and motor development measured on Bayley&#xD;
      Scales of Infant and Toddler Development. In addition it is expected that an improvement in&#xD;
      growth, home stimulation and mother's positive parenting. It is also expected that&#xD;
      improvement of the hemoglobin and micro-nutrient status (vitamin B12 and folic acid) over 150&#xD;
      children in the intervention group by the end of the project. At the same time it is expected&#xD;
      of a reduction on mothers' stress and depressive symptom and rate of maltreatment of children&#xD;
      by parents. A cost analysis will be conducted based on the success indicators, cost per&#xD;
      successful outcome will be calculated from total cost of intervention program.&#xD;
&#xD;
      Data Safety Monitoring Plan (DSMP)&#xD;
&#xD;
      Researcher group do not expect the low risk activities of this study to put the study&#xD;
      population at increased risk of adverse outcomes, however any human activity can have&#xD;
      unforeseen untoward consequences. researchers will actively monitor the impact of the&#xD;
      intervention on the population. The primary objective of these evaluations is to understand&#xD;
      practices, knowledge, and attitudes towards the interventions. researchers will include&#xD;
      questions in the evaluations that ask if they have noted any adverse outcomes.&#xD;
&#xD;
      If the field team learns of any adverse outcomes they will be trained to report them to the&#xD;
      study team the same day they learn of them.&#xD;
&#xD;
      Ethical Assurance for Protection of Human rights&#xD;
&#xD;
      The project will have to be approved by the Institutional Review Board of icddr,b.&#xD;
      Investigator group will collect written informed consent in Bengali from the parents before&#xD;
      starting data collection. Research group will ensure confidentiality when collecting data on&#xD;
      sensitive issues like maternal depression. Hard copies of the data will be kept in a locked&#xD;
      cabinet only accessible to the investigators. The electronic data will not have the name and&#xD;
      other identifiable information. Clinically depressed mothers will be referred to counsellors&#xD;
      or psychiatrists as needed. Children with mental retardation or developmental disabilities&#xD;
      will be referred to proper places for treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2015</start_date>
  <completion_date type="Actual">December 2016</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cognitive development (composite score of cognitive,motor, language and social-emotional development of children)</measure>
    <time_frame>Change from baseline at 11 months of intervention</time_frame>
    <description>cognitive development will be measured by Bayley tools. All individuals score will be aggregated in to composite score of cognitive,motor, language and social-emotional development of children</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maltreatment of children by the caregivers</measure>
    <time_frame>Change from baseline at 11 months of intervention</time_frame>
    <description>The International Society for the Prevention of Child Abuse and Neglect (ISPCAN) has developed ISPCAN Child Abuse Screening Tool- Parent Version (ICAST-P) will be used for measuring the severity of maltreatment calculating score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Height</measure>
    <time_frame>Change from baseline at 11 months of intervention</time_frame>
    <description>Height will be measure in centimeter through World Health Organization (WHO) guideline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Weight</measure>
    <time_frame>Change from baseline at 11 months of intervention</time_frame>
    <description>Weight will be measure in gram through World Health Organization (WHO) guideline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Head circumference</measure>
    <time_frame>Change from baseline at 11 months of intervention</time_frame>
    <description>Head circumference will be measure in centimeter through World Health Organization (WHO) guideline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Haemoglobin</measure>
    <time_frame>Change from baseline at 11 months of intervention</time_frame>
    <description>The Hematological measurement will be measured as Hb per g/dl ,</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>vitamin B12</measure>
    <time_frame>Change from baseline at 11 months of intervention</time_frame>
    <description>vitamin B12 will be measured as Pg/ml</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>folic acid status</measure>
    <time_frame>Change from baseline at 11 months of intervention</time_frame>
    <description>folic acid status will be measured as ng/ml</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Retinol</measure>
    <time_frame>Change from baseline at 11 months of intervention</time_frame>
    <description>The Hematological measurement will be measured as Retinol per Mg /ml</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>STfR per Mg/ml</measure>
    <time_frame>Change from baseline at 11 months of intervention</time_frame>
    <description>The Hematological measurement will be measured as STfR per Mg/ml</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mothers' stress and depressive symptoms</measure>
    <time_frame>Change from baseline at 11 months of intervention</time_frame>
    <description>the Rosenberg Self Esteem Scale (Rosenberg, 1965), the most widely used measure of self esteem for research purposes and Measurement of maternal depressive symptoms will be done using Center for Epidemiologic Studies Depression Scale (CESD)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Positive parenting practices,</measure>
    <time_frame>Change from baseline at 11 months of intervention</time_frame>
    <description>A questionnaire will be used to measure positive parenting</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">306</enrollment>
  <condition>Maltreatment</condition>
  <arm_group>
    <arm_group_label>ECD+</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Behavioral: Psychosocial stimulation, Cognitive behavioral therapy and positive parenting practice The mothers of intervention (ECD+HN) group will receive fortnightly group sessions for 12 months that will include combined messages on a) psychosocial stimulation, b) positive parenting to prevent child maltreatment and c) cognitive behavioural therapy (CBT) for positive thinking, d) health and nutrition messages and e) 15 micronutrient sprinkle supplement.(90 sachets of over 6 month-period)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Only regular health messages</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Only regular health message from government health services</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Psychosocial stimulation, Cognitive behavioral therapy and positive parenting practice</intervention_name>
    <description>The mothers of intervention (ECD+HN) group will receive fortnightly group sessions for 12 months that will include combined messages on a) psychosocial stimulation, b) positive parenting to prevent child maltreatment and c) cognitive behavioural therapy (CBT) for positive thinking, d) health and nutrition messages and e) 15 micronutrient sprinkle supplement.(90 sachets of over 6 month-period)</description>
    <arm_group_label>ECD+</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Mothers of 8 to 23 months old children, who practice maltreatment or harsh&#xD;
             child-discipline (screened by a previously used tool), will be included.&#xD;
&#xD;
          -  Children 8-23 months old with weight-for-length ≥-3 z score, MUAC ≥ 115 mm&#xD;
&#xD;
          -  Mothers are the primary caregivers and consented to participate.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  severe malnutrition nutritional edema, known developmental disability, chronic&#xD;
             illness, haemoglobin level &lt;8 gm/L (at enrolment). They will be referred to the nearby&#xD;
             health facilities for necessary clinical management&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Months</minimum_age>
    <maximum_age>23 Months</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Fahmida Tofail, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>International Centre for Diarrhoeal Disease Research, Bangladesh</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Fahmida Tofail, PhD</name>
      <address>
        <city>Dhaka</city>
        <country>Bangladesh</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Bangladesh</country>
  </location_countries>
  <link>
    <url>https://www.academia.edu/4936041/Perceived_Stress_and_Self-Esteem_as_Significant_Predictors_of_Cigarette_Smoking_Behavior_of_Bangladeshi_Male_Adults</url>
    <description>Uddin MK, Islam MT, Asaduzzaman M. Perceived Stress and Self-Esteem as Significant Predictors of Cigarette Smoking Behavior of Bangladeshi Male Adults.</description>
  </link>
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    <PMID>21944375</PMID>
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    <PMID>7678046</PMID>
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    <PMID>15652693</PMID>
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    <PMID>10793469</PMID>
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    <citation>Kumar V. Poisoning deaths in married women. J Clin Forensic Med. 2004 Feb;11(1):2-5. doi: 10.1016/j.jcfm.2003.10.010.</citation>
    <PMID>15261005</PMID>
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    <PMID>16452281</PMID>
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    <citation>Lind T, Lonnerdal B, Stenlund H, Gamayanti IL, Ismail D, Seswandhana R, Persson LA. A community-based randomized controlled trial of iron and zinc supplementation in Indonesian infants: effects on growth and development. Am J Clin Nutr. 2004 Sep;80(3):729-36. doi: 10.1093/ajcn/80.3.729.</citation>
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    <citation>Lovejoy MC, Graczyk PA, O'Hare E, Neuman G. Maternal depression and parenting behavior: a meta-analytic review. Clin Psychol Rev. 2000 Aug;20(5):561-92. doi: 10.1016/s0272-7358(98)00100-7.</citation>
    <PMID>10860167</PMID>
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    <citation>Murray L, Cooper P. Effects of postnatal depression on infant development. Arch Dis Child. 1997 Aug;77(2):99-101. doi: 10.1136/adc.77.2.99. No abstract available.</citation>
    <PMID>9301345</PMID>
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    <PMID>11991419</PMID>
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    <citation>Schellenberg JA, Victora CG, Mushi A, de Savigny D, Schellenberg D, Mshinda H, Bryce J; Tanzania Integrated Management of Childhood Illness MCE Baseline Household Survey Study Group. Inequities among the very poor: health care for children in rural southern Tanzania. Lancet. 2003 Feb 15;361(9357):561-6. doi: 10.1016/S0140-6736(03)12515-9.</citation>
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  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 13, 2016</study_first_submitted>
  <study_first_submitted_qc>January 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 25, 2017</study_first_posted>
  <last_update_submitted>January 22, 2017</last_update_submitted>
  <last_update_submitted_qc>January 22, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 25, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Early Childhood Development (ECD)</keyword>
  <keyword>Psychosocial stimulation</keyword>
  <keyword>Cognition</keyword>
  <keyword>Parenting</keyword>
  <keyword>Malnutrition</keyword>
  <keyword>Bangladesh</keyword>
  <keyword>Childhood Maltreatment</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/NCT03031236
org study id: PR-15002
nct id: NCT03031236
lead sponsor: 
collaborator: 
has dmc: No
Background (brief):

        1. Burden: The uniqueness of each child is tremendously influenced by interaction between
           nature and nurture during critical period of brain development that promotes foundation
           of brain architecture through neuronal connections.

        2. Knowledge gap: Young children in Bangladesh are prone to multiple physiological and
           psycho-social risk factors e.g. poverty, maltreatment, malnutrition, disease, parental
           illiteracy, maternal depression and lack of stimulation, all of which are preventable.
           Little is reported about any comprehensive package of development that addresses most of
           these early childhood risks and promotes optimum early childhood development (ECD).

        3. Relevance: The aim of this study is to develop and evaluate an integrated, low cost, and
           feasible center based approach that focuses on positive parenting of children during
           early life that will promote early stimulation, minimize childhood maltreatment, boost
           up of maternal self-esteem and healthy thinking and improve health and nutritional (HN)
           status of children.

      Hypothesis (if any):

      This integrated intervention will promote maternal child-care practices and mental health
      that will finally improve their children's growth, micro-nutrient status, early brain
      development compared to control group.

      Objectives:

      To see the effect of an integrated intervention (ECD + HN) on growth, micro-nutrient status,
      child development along with effect on maternal child-care practices and mental health.

      Methods:

      Randomly selected 2 groups will be identified as intervention and control (150 mothers'
      from15 clusters in each group). Mothers of 8-23 months old children living in slums and
      practice harsh child-disciplining will be identified as study population. The mothers of
      intervention (ECD+HN) group will receive fortnightly group sessions for 11 months that will
      include combined messages on a) psycho-social stimulation, b) positive parenting to prevent
      child maltreatment and c) cognitive behavioral therapy (CBT) for positive thinking, d) health
      and nutrition messages and e) 15 micro-nutrient sprinkle supplement.(90 sachets of over 6
      month-period). The control group will only receive the usual health messages provided by the
      government.

      Outcome measures/variables:

        -  Children's cognitive, motor, language and socio-emotional development; anthropometry;
           hemoglobin and micro-nutrient status (serum vitamin B12, iron and folic acid)

        -  Mother s' parenting practices, depressive symptoms, self-esteem and child-maltreatment.
Hypothesis to be tested:

      This integrated intervention will a) improve children's growth, hemoglobin, micro-nutrient
      status (vitamin B12 and folic acid), cognitive, motor, language and social-emotional
      development, b) minimize maltreatment of children by parents, c) improve positive parenting
      and d) reduce mothers' stress and depressive symptoms compared to control group.

      Objectives:

      Primary: This integrated intervention will

        -  Improve cognitive, motor, language and social-emotional development of children

        -  Minimize maltreatment of children by the caregivers

      Secondary: This integrated intervention will bring following benefits in intervention group
      compared to control group- On children-

        -  Improve height, weight and head circumference

        -  Improve hemoglobin, vitamin B12 and folic acid status, On mothers (primary caregivers)

        -  Reduce mothers' stress and depressive symptoms

        -  Improve positive parenting practices

      Background of the Project including Preliminary Observations:

      The rate of global acute malnutrition is 16% while the rate of stunting in Bangladesh is as
      high as 41% in <five yrs children. Moreover, the children in Bangladesh are either deficient
      in different micro-nutrients like iron 10.7% and iodine 34% or have inadequate
      micro-nutrients in their diets like vitamin B12 and folate which is less than 50%. Many
      children in developing countries fail to reach their developmental potential due to lack of
      cognitive stimulation and Bangladeshi children have limited access to play materials and
      activities.

      According to Walker and colleagues 300 million children are exposed to violence globally. Our
      unpublished data show that 32% of children <2 years are subjected to maltreatment and harsh
      punishment in Bangladesh.

      Depression is one of the leading causes of disease burden for women and children of these
      mothers may suffer from behavioral problems.. Depression is reported as a leading cause of
      disease burden for women aged 15-44 years in all countries. The South Asia has the least
      woman-friendly societies in the world. Maternal depression is becoming a major public health
      problem in these societies, partly due to gender roles and practices and partly to poverty.
      Depression indicates state of mind that causes symptoms like crying spells, sleeping
      problems, depressed mood, irritability, fatigue, anxiety, poor concentration and
      interpersonal hypersensitivity, and these can range from mild to severe in nature. Maternal
      depression not only affects mothers' health, evidenced by poorer nutrition, higher suicide
      attempts and self harm but also results in poor health and developmental outcomes of their
      children.

      In Bangladesh prevalence of anxiety and depressive symptoms are as high as 18-33% and we
      found a significant association with child maltreatment in an urban community on). Rahman et
      al. tested an innovative model of community-based management of depression using Cognitive
      Behavioral Therapy (CBT) in Pakistan and reported improvement in maternal depression 6 months
      postpartum. Considering similar family structure, religion and culture between Bangladesh and
      Pakistan, it is likely that the program will work in Bangladesh too.

      Despite prevalent child maltreatment in Bangladesh, there are very few interventions to
      reduce maltreatment and those for children under 5 yrs of age are even rarer. Similarly,
      though attention has been diverted to ECD for several years now, very few of those programs
      address children under 3 yrs of age. Study design would probably be the 1st intervention
      using a robust research method to test the efficacy of an integrated method to address ECD,
      child maltreatment as well as health and nutrition of young children. Investigators will
      modify existing curriculum to further focus on child maltreatment. Investigators have
      targeted poor families from urban slums who are deprived of such services but face most of
      the risk factors and hope to improve their families' condition using low-cost intervention.
      Researchers have targeted the mothers as study participants who also primary caregiver of a
      child especially at younger age and have a major role in the child development. Mothers are
      also more vulnerable for depression than the fathers in Bangladeshi culture.

      In addition, there is no culturally appropriate tool to assess child maltreatment in
      Bangladesh. In this project researchers attempt to modify or adapt existing instruments or if
      needed develop new tools suitable for use in Bangladesh.

      Research Design and Methods

      Population and sample size:

      This study will be conducted in the semi-urban area (preferably in Kamalapur) of Dhaka,
      Bangladesh. Total sample is 10 mother-child duos in randomly selected 30 clusters ( n=300),
      half of which (n=150) will be beneficiaries from the intervention.

      Plan of work: The intervention package will be piloted in the non study community for its
      feasibility and will be modified accordingly. The selected mother-child duos will be invited
      to field office for baseline assessments. Intervention group will be invited to join the
      center-based group sessions fortnightly for one year, the control group will receive existing
      government health messages. Both the groups will receive free health service from study
      medical officer for acute illnesses. After a year, final assessments will be done in both the
      groups. At baseline and end line mother-child interaction will be observed in a sub-sample of
      the population.

      Procedures:

      It will be a cluster-randomized trial. Clusters will be formed based on number of household
      members (those using the same cooking pot) as well as geographical boundary. On average there
      will be 150-200 households in each cluster, but there may be some variation in household
      numbers per cluster and per stratum.Total sample will be 10 mother-child duos in randomly
      selected 30 clusters (n=300), half of which (n=150) will be beneficiaries from the
      intervention.

      Plan of work: The intervention package will be piloted in the non study community for its
      feasibility and will be modified accordingly. The selected mother-child duos will be invited
      to field office for baseline assessments. Intervention group will be invited to join the
      center-based group sessions fortnightly for 1 year, the control group will receive existing
      government health messages. Both the groups will receive free health service from study
      medical officer for acute illnesses. After a year, final assessments will be done in both the
      groups. At baseline and end line mother-child interaction will be observed in a sub-sample of
      the population. At the beginning of the study, 4 Focus group discussions of (8-10 non-study
      mothers) will be conducted in the community to know about the mothers' parenting practices.
      At the middle of the study qualitative information (case report and 30 In-Depth Interviews)
      will be collected form the intervened mothers about the intervention package they are
      receiving. Intervened mothers will be interviewed at their home according to their time
      availability. Key Informant's Interview (KII) will be conducted after a year from 2 play
      leaders (who will deliver the intervention) and 2 supervisors (who will train the play
      leaders and monitored them). Interviews will be taken and tape recorded with consent of the
      participants.

        1. Preparatory works: At the first phase researchers will select the site and also complete
           the process of 'Ethical Review' of the project.

           Screening and enrollment: After taking the consent, screening of mothers of 8 to 23
           months old children, who practice harsh discipline will be conducted in 30 identified
           clusters by trained health workers using ISPCAN Child Abuse Screening Tool-Parent
           Version (ICAST-P). Researchers have already used the modified version of these tools in
           Bangladesh. According to primary investigation there are 10% mothers having 8 to 23
           months old children in study field site. With this estimation to get 10 eligible mothers
           from each cluster researcher group have to screen 100 mothers. Mothers who will fulfill
           the study enrollment criteria will be offered to join the study and will be invited to
           the test centers for baseline assessments.

           At the same time research group will start developing the study materials:

           For intervention: Development and piloting of following manuals, that already exist and
           needs further simplification and adaptations

             -  Psycho-social stimulation for individual visits

             -  Cognitive behavioral therapy For assessments: Cultural adaptation, Standard
                Operating Procedures (SOPs) preparation and field testing of following tools

             -  Bayley Scale of Infant and Toddler Development (Already adapted, we have to take
                permission from Pearson's to use it)

             -  Field testing and adaptation of ISPCAN Child Abuse Screening Tool -Parent Version
                (ICAST-P)

             -  Qualitative questionnaires

             -  Observational tools

           Tools that are adapted, tested and ready to use

             -  Parenting questionnaire

             -  Home observation for measurement of environment (HOME)

             -  Rosenberg Self Esteem Scale

             -  CES-D to measure depressive symptoms

             -  Socio-economic status (SES) questionnaire

             -  Wolke's Behavior Rating scale

             -  Anthropometric measurements

        2. Baseline assessment:

           On children:

           Bayley Scales of Infant and Toddler Development (Bayley-III) will be used to assess
           cognitive, language and motor development of the children. The test has been used in
           many developing countries, and has been the instrument of choice for much nutrition and
           child development research at this age in other countries like Indonesia and Brazil. The
           Bayley has often been sensitive to changes following interventions. Because the Bayley
           has not been standardized in Bangladesh, researcher will not compare these children's
           scores with the test norms or children of other countries. Study aim is only to compare
           the development of groups of children within the same community. Bayley usually takes
           about an hour to test the children.

           The children's behavior during the Bayley tests will be rated on five 9-point scales
           using a modified version of the scales developed by Wolke (1990). These ratings include
           infants' activity (very still=1 to overactive=9), emotional tone (unhappy=1 to radiates
           happiness=9), approach or responsiveness to examiner in the first 10 minutes
           (avoiding=1to friendly and inviting=9), cooperation with test procedure (resists all
           suggestions=1to always complies=9), and vocalization (very quiet=1to constant
           vocalization=9). The scale has been used in several studies in Bangladesh and was
           sensitive to intervention effects .

           Anthropometry: Mother and child's anthropometric measurements (height and weight of
           mothers; length/height, weight, MUAC and head circumference of children) will be
           assessed at using standard procedures.

           On mothers':

           Maternal self esteem: This will be assessed using adapted version of the Rosenberg Self
           Esteem Scale, the most widely used measure of self esteem for research purposes. It has
           been used previously in Bangladesh by this research team and by others as a valid
           instrument.

           Information on child maltreatment and neglect: The International Society for the
           Prevention of Child Abuse and Neglect (ISPCAN) has developed ISPCAN Child Abuse
           Screening Tool- Parent Version (ICAST-P) that has been widely used in developing
           countries, like India and Jamaica. This research group already used modified version of
           this tool in Bangladesh on hospital mothers.

           Measurement of maternal depressive symptoms will be done using Center for Epidemiologic
           Studies Depression Scale (CES-D). This tool has been used in Bangladesh and South-East
           Asian countries.

           Quality of stimulation at home was assessed using Caldwell's Home Observation for
           Measurement of Environment (HOME) which was modified for Bangladesh and was used in
           other studies by the same research team.

           Other measurements: These following measures will be collected as covariates -
           Socioeconomic status: On enrollment information will be collected on the family's assets
           (furniture e.g. bed/tables/chairs, electrical household equipment's e.g. radio/TV/fan,
           farm animals, vehicles e.g. rickshaw/boat/bicycle/motorbike, etc.), housing condition
           (type of roof, floor and walls), access to water and sanitation, electricity, crowding
           condition, and parental education and occupation. An asset quintile will be created from
           all available assets available at household level.

           Observational tools: Structured observation checklist will be used to see mother-child
           interaction Qualitative assessments will be used to conduct focus group discussion, in
           depth interviews and case reports.

        3. Intervention:

      It will be a low cost intervention focusing on building awareness among population at risk
      through hands on training delivered by trained health workers with minimum educational level
      and low salary. Our previous experience shows that it is possible to train paraprofessionals
      to provide intervention of this intensity. We have also shown that psycho-social stimulation
      provided for 10 or 12 months can improve the development and behavior of children
      significantly. Two weeks training and one week's field practice will be required to train
      these staff. We will train the play leaders regarding the whole intervention package
      including stimulation, Cognitive Behavioral Therapy, health and nutrition messages that
      include infant and young child feeding practices, good hygiene practice, and positive
      parenting messages (stimulation, learning through play, love and affection). There will be
      one-hour sessions fortnightly for 11 months. Attending 2 sessions per month is feasible for
      the mothers. This intervention will address the major risk factors e.g. negative parenting,
      lack of stimulation, child maltreatment, malnutrition, maternal stress/depressive symptoms,
      faulty care-seeking practices due to knowledge gap, etc. using a combined package.

      There will be a combination of 3 types of interventions:

      (i) Early stimulation and prevention of maltreatment through positive parenting, boosting up
      of maternal self-esteem and stress management (ECD): Psycho-social stimulation intervention
      will follow a set of culturally appropriate, semi-structured, child's age appropriate
      curriculum. This integrated approach will be given in groups of mothers and child. During the
      session the field-workers will show the mothers how to play with home-made toys and books and
      interact with their children in a way to promote their development. Along with the
      stimulation program, the field workers will also provide some advice regarding positive
      parenting and boosting up maternal self esteem and stress management. Care will be taken to
      appreciate mothers for their activities and positive reinforcement will be strongly
      encouraged. The developmental activities will be conducted in a playful manner and not as a
      work-oriented activity. The activities in the curriculum will be ordered by difficulty level
      and the health workers will be trained to choose the level for each child according to their
      ability to do the activities.

      (ii) Health education and sprinkles supplementation (HN): The participants will receive
      health and nutrition messages to improve children's health. In addition children will receive
      multiple micro-nutrient powder (Vitamin A 400 µg, vitamin D 5 µg, vitamin E 5 mg, vitamin C
      30 mg, thiamine 0.5 mg, riboflavin 0.5 mg, niacin 6 mg, pyridoxine 0.5 mg, vitamin B12 0.9
      mg, folate 150 µg, iron 10 mg, zinc 4.1 mg, copper 0.56 mg, selenium 17.0 µg and iodine 90
      µg) supplementation at household level (90 sachets of over 6 month-period).

      (iii) Cognitive Behavioral Therapy: Intervention to help mothers change their negative
      behaviour and to improve self care, child care, income generation activities, will follow the
      "Thinking Healthy Program" model of Rahman and colleague using cognitive behavior therapy
      (CBT). CBT will improve maternal behaviour leading to "positive parenting" and prevention of
      maltreatment. Cognitive Behavioral Therapy is an "evidence-based and structured form of
      talking therapy that aims to alter the cycle of unhelpful or unhealthy thinking (cognition)
      and the resulting undesirable actions (behavior)." Cognitive Behavioral Therapy specifically
      focused on "changing thinking style toward positive" and not associated with any medication.
      CBT found to be effective in managing or treating not only depression, also a variety of
      other conditions-e.g. mood, personality, stress, eating habit, tic etc.This approach with
      rural mothers of similar context showed positive impact on child outcome in Pakistan, which
      is culturally and economically similar to Bangladesh.

      CBT is aimed to alter the cycle of negative thinking of people to positive direction. The
      cycle of negative thoughts usually breaks in two ways by using Cognitive and Behavioral
      aspect of the therapy -

        -  Cognitive aspect of CBT: This focuses on altering ways of thinking of a person (mother)
           that includes thoughts, beliefs, ideas, attitudes, assumptions, mental imagery, and ways
           of directing her attention.

        -  Behavioral aspect of CBT: This focuses on helping the mother to face the challenges and
           the opportunities that facilitates child-raising with a sound and clear mind- and then
           to take necessary actions that are likely to have desired outcomes.

      This model is proven to be an effective approach in breaking the cycle of depression and
      improving confidence, coping strategies and assertiveness in poor community with low resource
      setting. The cycle is broken through two ways of CBT- cognitive aspect (directing attention
      to positive direction) and behavioral aspect (helping to meet challenges).

      d) Final assessment, data entry and data analysis: After 11 months of intervention, the
      participants will be invited again in the centre for end line assessment. The same assessment
      tools will be used as in the base line. Simultaneous data entry will continue in SPSS
      software. After data cleaning, preliminary analysis will be done according to following plan.

      All the baseline variables will be used to compare between lost and tested groups as well as
      the intervention and control groups. The two time-point assessment will also provide
      information about within group changes. Some variables e.g. HOME, mother-child interaction,
      parenting, childcare etc. will be used either as mediator or as outcome in separate analyses

      Outcome Variables:

      On Mothers-

        1. Maternal stress and depressive symptoms using CES-D at baseline and at the end.

        2. Self Esteem assessment using Rosenberg Self Esteem Scale at baseline and at the end in
           test centre

        3. Information about child maltreatment by parents will be collected at baseline during
           screening at home and at the end.

        4. Home observation for measurement of environment (HOME) at household level, twice (at
           baseline and at the end)

      On Children-

        1. Child's cognitive, motor and language assessment using Bayley-III and behavioral
           assessment during test using Wolke's Behavior Rating Scale, at baseline and at the end
           in test centre. Children will accompany their mothers to the centre. (45 min)

        2. Children's Micronutrient status (vitamin B12 and folic acid) at baseline and at the end
           in test centre

        3. Children's Hemoglobin status

        4. Children's height, weight, MUAC, head circumference at baseline and at the end

      Covariates-

        1. Socio-economic variables (asset index/ quintile)

        2. Demographic variables (housing/ sanitation)

        3. Maternal nutritional status (BMI)

        4. Child's age and sex

        5. Compliance on micro-nutrients and dietary recall

        6. Morbidity Sample Size Calculation and Outcome (Primary and Secondary) Variable(s)

      Considering 5% level of significance, 80% power, an improvement of 0.4 SD in children's
      developmental outcome based on our previous experiences, an ICC of 0.01 and 30% drop outs, we
      need to enroll 150 mother-child duos in each group as per equation below- 2(SD)2 n =
      ---------------- X f (αβ) (M1-M2) 2

      n: sample required, SD: 16 (based on previous data of Bayley Score) α: 5% level of
      significance β: 80% power f= α*β M1-M2 = Difference = 6.4 points (based on previous studies)
      So the calculated n=100

      Considering the clustering we need to adjust this sample size by multiplying the above value
      (100) by the design effect.

      Design Effect = 1 + [(m-1) * ICC m corresponds to the average number of infants per cluster.
      Assuming there are on average 10 mother-child duos/cluster.

      Using ICC = 0.01, the design effect = 1 + [(10-1) * ICC = 1 + 0.9 = 1.09 Therefore new sample
      size = 100*1.09= 109 per group , considering 30% drop-out the sample size per group is around
      150 infants in stimulation group and 150 infants in control group.

      Data Analysis

      icddr,b scientists and co-investigators of this research project will analyze the data using
      Stata/SPSS. All data will be checked for normality. Log transformation will be done if not
      normally distributed. Indices will be created where it is required (eg: SES index, housing
      index etc). Pearson's correlations will be conducted to examine the association between age
      of the child and each developmental measure. A comparison will be done between the
      socio-demographic characteristics of the intervened and control groups using t-test for
      continuous variables and χ2 for categorical variables. Partial correlation will be used
      controlling age and sex to examine association of different covariates with developmental
      scores.

      Finally, multi-level regression analyses will be done. In each regression analysis, the
      outcome will be the final developmental score, with age at enrollment, the relevant initial
      scores, and intervention as predictors. Again, comparison will be done between the treatment
      effect in intervention and control groups. All variables that will be different between
      intervention and control groups at baseline and will correlate with the developmental
      outcomes and will address high co-linearity among the covariates in all analyses.

      The main outcomes are children's cognitive, language and motor development measured on Bayley
      Scales of Infant and Toddler Development. In addition it is expected that an improvement in
      growth, home stimulation and mother's positive parenting. It is also expected that
      improvement of the hemoglobin and micro-nutrient status (vitamin B12 and folic acid) over 150
      children in the intervention group by the end of the project. At the same time it is expected
      of a reduction on mothers' stress and depressive symptom and rate of maltreatment of children
      by parents. A cost analysis will be conducted based on the success indicators, cost per
      successful outcome will be calculated from total cost of intervention program.

      Data Safety Monitoring Plan (DSMP)

      Researcher group do not expect the low risk activities of this study to put the study
      population at increased risk of adverse outcomes, however any human activity can have
      unforeseen untoward consequences. researchers will actively monitor the impact of the
      intervention on the population. The primary objective of these evaluations is to understand
      practices, knowledge, and attitudes towards the interventions. researchers will include
      questions in the evaluations that ask if they have noted any adverse outcomes.

      If the field team learns of any adverse outcomes they will be trained to report them to the
      study team the same day they learn of them.

      Ethical Assurance for Protection of Human rights

      The project will have to be approved by the Institutional Review Board of icddr,b.
      Investigator group will collect written informed consent in Bengali from the parents before
      starting data collection. Research group will ensure confidentiality when collecting data on
      sensitive issues like maternal depression. Hard copies of the data will be kept in a locked
      cabinet only accessible to the investigators. The electronic data will not have the name and
      other identifiable information. Clinically depressed mothers will be referred to counsellors
      or psychiatrists as needed. Children with mental retardation or developmental disabilities
      will be referred to proper places for treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Cognitive development (composite score of cognitive,motor, language and social-emotional development of children)
time frame: Change from baseline at 11 months of intervention
description: cognitive development will be measured by Bayley tools. All individuals score will be aggregated in to composite score of cognitive,motor, language and social-emotional development of children
measure: Maltreatment of children by the caregivers
time frame: Change from baseline at 11 months of intervention
description: The International Society for the Prevention of Child Abuse and Neglect (ISPCAN) has developed ISPCAN Child Abuse Screening Tool- Parent Version (ICAST-P) will be used for measuring the severity of maltreatment calculating score.
measure: Height
time frame: Change from baseline at 11 months of intervention
description: Height will be measure in centimeter through World Health Organization (WHO) guideline.
measure: Weight
time frame: Change from baseline at 11 months of intervention
description: Weight will be measure in gram through World Health Organization (WHO) guideline.
measure: Head circumference
time frame: Change from baseline at 11 months of intervention
description: Head circumference will be measure in centimeter through World Health Organization (WHO) guideline.
measure: Haemoglobin
time frame: Change from baseline at 11 months of intervention
description: The Hematological measurement will be measured as Hb per g/dl ,
measure: vitamin B12
time frame: Change from baseline at 11 months of intervention
description: vitamin B12 will be measured as Pg/ml
measure: folic acid status
time frame: Change from baseline at 11 months of intervention
description: folic acid status will be measured as ng/ml
measure: Retinol
time frame: Change from baseline at 11 months of intervention
description: The Hematological measurement will be measured as Retinol per Mg /ml
measure: STfR per Mg/ml
time frame: Change from baseline at 11 months of intervention
description: The Hematological measurement will be measured as STfR per Mg/ml
measure: Mothers' stress and depressive symptoms
time frame: Change from baseline at 11 months of intervention
description: the Rosenberg Self Esteem Scale (Rosenberg, 1965), the most widely used measure of self esteem for research purposes and Measurement of maternal depressive symptoms will be done using Center for Epidemiologic Studies Depression Scale (CESD)
measure: Positive parenting practices,
time frame: Change from baseline at 11 months of intervention
description: A questionnaire will be used to measure positive parenting
arm group label: ECD+
arm group type: Active Comparator
description: Behavioral: Psychosocial stimulation, Cognitive behavioral therapy and positive parenting practice The mothers of intervention (ECD+HN) group will receive fortnightly group sessions for 12 months that will include combined messages on a) psychosocial stimulation, b) positive parenting to prevent child maltreatment and c) cognitive behavioural therapy (CBT) for positive thinking, d) health and nutrition messages and e) 15 micronutrient sprinkle supplement.(90 sachets of over 6 month-period)
arm group label: Only regular health messages
arm group type: No Intervention
description: Only regular health message from government health services
intervention type: Behavioral
intervention name: Psychosocial stimulation, Cognitive behavioral therapy and positive parenting practice
description: The mothers of intervention (ECD+HN) group will receive fortnightly group sessions for 12 months that will include combined messages on a) psychosocial stimulation, b) positive parenting to prevent child maltreatment and c) cognitive behavioural therapy (CBT) for positive thinking, d) health and nutrition messages and e) 15 micronutrient sprinkle supplement.(90 sachets of over 6 month-period)
arm group label: ECD+
criteria: 
gender: All
minimum age: 8 Months
maximum age: 23 Months
healthy volunteers: Accepts Healthy Volunteers
last name: Fahmida Tofail, PhD
role: Principal Investigator
affiliation: International Centre for Diarrhoeal Disease Research, Bangladesh
facility: 
country: Bangladesh
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responsible party type: Sponsor
sharing ipd: No