<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/NCT03025646</url>
  </required_header>
  <id_info>
    <org_study_id>PR-16070</org_study_id>
    <nct_id>NCT03025646</nct_id>
  </id_info>
  <brief_title>Feasibility of Implementing a Mental Health Care Program and Home-based Training for Mothers of Children With Autism Spectrum Disorder in an Urban Population in Bangladesh</brief_title>
  <official_title>Feasibility of Implementing a Mental Health Care Program and Home-based Training for Mothers of Children With Autism Spectrum Disorder in an Urban Population in Bangladesh</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>International Centre for Diarrhoeal Disease Research, Bangladesh</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Harvard Medical School (HMS and HSDM)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute of Mental Health (NIMH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute of Neurosciences Hospital (NINS)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Institute of Paediatric Neurodisorder and Autism (IPNA)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>International Centre for Diarrhoeal Disease Research, Bangladesh</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background (brief):&#xD;
&#xD;
      The global burden of depression accounts for 2.5% of global DALYs, and in South Asia the&#xD;
      estimate is 13.3 % of DALYs per 100,000 populations. Mothers of children with Autism Spectrum&#xD;
      Disorder (ASD) have reported higher level of depression than mothers of children with other&#xD;
      developmental disorder and the prevalence of ASD is high in Asian countries. In Bangladesh&#xD;
      16% of adults suffer from depression and a recent study conducted in Bangladesh has&#xD;
      documented a high prevalence of depression among mothers of children with ASD (45%). Mothers&#xD;
      are the life time care givers of children with ASD, and a high burden of depression is likely&#xD;
      negatively impact on the ability of the mothers to provide care to children at home. Mental&#xD;
      health is not addressed in Bangladesh and there is scarcity of qualified providers.&#xD;
&#xD;
      Objectives:&#xD;
&#xD;
      The investigators propose to pilot the feasibility of a package intervention including&#xD;
      implementation of mental health care and home based training program for the mothers of&#xD;
      children with ASD integrated in the regular activities of the special schools that offer ASD&#xD;
      care in Dhaka city in Bangladesh.&#xD;
&#xD;
      Methods:&#xD;
&#xD;
      The study will be conducted in 2 selected special schools over 15 months. In the first stage,&#xD;
      the investigators will set up the study in two schools and identify various stakeholders for&#xD;
      qualitative assessment of the barriers of implementing the intervention at the institutional&#xD;
      level, individual level, family level, provider level, policy maker level and at the level of&#xD;
      the state. Research staff will identify mothers 18 years of age or older who has a child with&#xD;
      ASD between 3 and 17 years of age enrolled in the school. Following consent, data collector&#xD;
      will obtain data and assess current major depressive episode (MDE) of the eligible mothers&#xD;
      following a standard diagnostic tool (SCID-I). All mothers diagnosed as having MDE will be&#xD;
      invited to participate in the intervention (intervention mothers) and the investigators will&#xD;
      assess the performances in children with ASD by applying ASD Diagnostic Check-list (ADCL).&#xD;
&#xD;
      In the second stage, investigators will implement interventions over 4-6 months, including&#xD;
      (a) implementing mental health care services at the selected schools targeting the&#xD;
      intervention mothers, and (b) organizing training sessions of the intervention mothers for&#xD;
      supporting child care at home for enhancing child performances. Every month a psychiatrist&#xD;
      will visit each school for providing necessary advice and treatment to the intervention&#xD;
      mothers or suggest referral to hospital care, if necessary.&#xD;
&#xD;
      One special educator will be deployed at each school who will organize structured training&#xD;
      sessions for educating the intervention mothers by using BCC materials developed and&#xD;
      validated by icddr,b in the local setting. The special educators will conduct multiple group&#xD;
      sessions including 5-8 mothers in each group for covering the 6 modules over 2 weeks time,&#xD;
      and follow up intervention mothers at home every month for conducting refresher's training,&#xD;
      documenting the need of additional training supports, and linking mother with an ASD expert&#xD;
      for helping mothers taking a decision.&#xD;
&#xD;
      In stage 3, investigators will conduct post intervention qualitative survey with various&#xD;
      stakeholders who would be involved with implementing the intervention and participated in the&#xD;
      baseline qualitative survey. End line assessment will be conducted of current major&#xD;
      depressive episode (MDE) among all mothers and assess the performance of the children of&#xD;
      intervention mothers in order to assess the impact of the training at home.&#xD;
&#xD;
      Outcome measures/variables:&#xD;
&#xD;
      The primary outcome of the study is to assess the feasibility of institutionalizing the&#xD;
      combined intervention of mental health care supports and the home based training program of&#xD;
      the mothers who would be diagnosed as having major current major depressive episode. The&#xD;
      primary outcome will be assessed by obtaining the perspectives of various stakeholders. The&#xD;
      following parameters will be assessed for measuring feasibility of the proposed intervention.&#xD;
&#xD;
      Acceptability, Adaptability, Demands, Practicality, Implementation, Integration&#xD;
&#xD;
      The secondary outcomes will include estimating the impact of the combined interventions on&#xD;
      the prevalence rate of maternal depression (MDE), individual performances of children, and&#xD;
      cost of intervention. Adaptation of the proposed strategy, if feasible will help the mothers&#xD;
      of children with ASD become skilled workforces for filling in the gap of the special&#xD;
      educators in resource poor settings, and extension of these services to more children with&#xD;
      ASD.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will be conducted in 2 selected special schools in Dhaka city, (i) Autiam welfare&#xD;
      Foundation (AWF: http://awfbd.com/) and (ii) Society for the Welfare of Autistic Children&#xD;
      (SWAC: http://www.ASDbd.com/swac-bd/) who have more than 10 years of experiences with&#xD;
      offering quality services for ASD care in Bangladesh. The investigator will conduct the study&#xD;
      in both schools in 3 stages:&#xD;
&#xD;
        -  Preparatory phase and baseline assessment (stage 1)&#xD;
&#xD;
        -  Implementation of intervention (stage 2)&#xD;
&#xD;
        -  End line assessment (stage 3)&#xD;
&#xD;
      Stage 1:&#xD;
&#xD;
      The investigator will set up the study in two schools and identify various stakeholders&#xD;
      including the managers of the schools, special educators, psychologists, psychiatrists,&#xD;
      medical doctors, parent of children with ASD, policy makers etc. Data collector will obtain&#xD;
      written const from them and conduct in depth interviews for assessing barriers of&#xD;
      implementing the intervention at institutional level, individual level, family level,&#xD;
      provider level, policy makers level and at the level of the state prior to intervention.&#xD;
&#xD;
      Research staff will identify those mothers who are at least 18 years of age and has a child&#xD;
      with ASD between 3 and 17 years of age enrolled in the school. The staff in the intervention&#xD;
      phase would not be involved in the baseline or end line surveys. The investigator will&#xD;
      recruit separate staff for conducting baseline and end line surveys. Data collector will&#xD;
      obtain additional school based information regarding the children's ASD diagnosis and an&#xD;
      expert from IPNA will reconfirm their ASD by ADCL in order to further validate and rate the&#xD;
      ASD diagnoses with health and education related information.&#xD;
&#xD;
      Data collector will obtain written consent from the eligible mothers who have child with ASD&#xD;
      and obtain essential socio demographic and other relevant data, and perform clinical&#xD;
      diagnosis of major depressive disorder (MDD) and current major depressive episode (MDE)&#xD;
      following a standard diagnostic tool (SCID-I) based on DSM-IV criteria as it has already been&#xD;
      validated through several studies in Bangladesh. All mothers diagnosed as having MDE will be&#xD;
      invited to participate in the intervention following a written consent (intervention&#xD;
      mothers). However, any mother identified with severe forms of depression with any suicidal&#xD;
      ideation or unsafe thoughts will be referred for urgent hospital based mental health services&#xD;
      in the community (as per standard of care and ethical obligations), and they will not be&#xD;
      invited to participate in the study. The selected schools would have at least 100-150&#xD;
      children with ASD enrolled in a given year, and we anticipate that a total of ~ 54 to 80&#xD;
      mothers will participate in the intervention. Data collector will interview the intervention&#xD;
      mothers in order to assess the individual performances of their children by using a standard&#xD;
      tool ADCL (ASD Diagnostic Check-list). ADCL is a standard tool applied by ASD experts in&#xD;
      Bangladesh to track improvement in performances in children with ASD [22].This tool comprises&#xD;
      of 60 items focusing on 6 major areas of ASD, including (i) General Observation (13 items),&#xD;
      (ii) Cognition (10 items), (iii) Emotion (8 items), (iv) Social/Self Help (8 items), (v)&#xD;
      Communication (12 items), and (vi) Sensory deficiency (9 items).&#xD;
&#xD;
      Stage 2:&#xD;
&#xD;
      From day 0 of the study period investigator will initiate setting up the intervention in two&#xD;
      schools, which will include two components; (a) Implementing mental health care services at&#xD;
      schools targeting the mothers diagnosed as having depression who have consented to&#xD;
      participate in the study (intervention mother) and (b) Organizing training sessions of the&#xD;
      intervention mothers for supporting enhanced child care at home. Although the mental health&#xD;
      services will target mothers who would volunteer to participate in the intervention. The&#xD;
      proposed intervention will be implemented over 4-6 months period; the two components of the&#xD;
      package have been described below in details.&#xD;
&#xD;
        1. . Implementing mental health care services at school&#xD;
&#xD;
           The investigator will develop a counseling centre at each school by deploying one&#xD;
           trained female psychologists who would provide counseling to the intervention mothers.&#xD;
           Investigator will adopt the psychological management procedures that have been commonly&#xD;
           administered by the experts of National Institute of Mental Health, Bangladesh (NIMH,&#xD;
           B). Intervention guidelines will be submitted to ERC for reviewing and necessary&#xD;
           approval of the document before the final application in the study. The mental health&#xD;
           services counseling module will comprises of the following topics:&#xD;
&#xD;
             1. Psycho education&#xD;
&#xD;
                Psycho education refers to the education offered to individuals with a mental&#xD;
                health condition and their families to help empower them and deal with their&#xD;
                condition in an optimal way. Psycho education will be given by a trained&#xD;
                psychologists under the guidance of a psychiatrists to increase the self esteem of&#xD;
                the mothers, which will include the brief concept on depression, the probable&#xD;
                etiology, how to mitigate the symptoms, compliance to the therapeutic process and&#xD;
                the consequences. This method of psychological management is commonly practiced by&#xD;
                the psychologists and also has been used in the former studies in Bangladesh.&#xD;
&#xD;
             2. Assessment of the strength and weakness of the mothers&#xD;
&#xD;
                The psychologists will assess the strengths and weakness of the mothers, and&#xD;
                discover their personal obstacles, issues that might hinder their progress in terms&#xD;
                of social context, family support, financial state, educational qualification,&#xD;
                empowerment etc.&#xD;
&#xD;
             3. Sharing the management plan with the mothers The psychologists will share the whole&#xD;
                management processes with the mothers and any opinion from the mother could be a&#xD;
                part of the management. The goal is to empower mothers and include them as a part&#xD;
                of the management team counseling other mothers.&#xD;
&#xD;
             4. Reconstruction of the cognition Cognitive restructuring is a psychotherapeutic&#xD;
                process of learning to identify and dispute irrational or maladaptive thoughts&#xD;
                known as cognitive distortions. It is a core part of Cognitive Behavioral Therapy&#xD;
                (CBT). CBT is a structured method and one of the most effective psychological&#xD;
                treatments commonly used by the psychiatrists and psychologists of Bangladesh to&#xD;
                intervene depression. To manage depression minimum 12 sessions are required which&#xD;
                can be more upon the severity of the clients. CBT mainly deals with exploring&#xD;
                problems, thoughts, feelings and behavior of the clients. It is one of the major&#xD;
                components of our intervention protocol based on the standard practice of the&#xD;
                experts of Bangladesh.&#xD;
&#xD;
             5. Behavior therapy- graded activity Graded activity is a principle of therapeutic&#xD;
                intervention in which tasks are classified and gradually presented according to the&#xD;
                client's level of function and the challenge or degree of skill (physical, social,&#xD;
                or cognitive) required by the task. In this study after assessing the strengths and&#xD;
                weaknesses of the mothers their functional activity also be monitored and will try&#xD;
                to increase. The graded activity starts from personal care, daily household&#xD;
                activities, child care, engagement in small and easy tasks and complex and&#xD;
                productive tasks.&#xD;
&#xD;
             6. Developing a mother's community and engaging depressed mothers in community related&#xD;
                activities&#xD;
&#xD;
           The psychologist will arrange a workshop in each participating school at two months&#xD;
           interval for enabling mothers meet other mothers in the intervention and create a common&#xD;
           platform where they can share their experiences , success stories and encourage a&#xD;
           positive reinforcement on the depressed mothers. The mothers will be encouraged to&#xD;
           participate in the social awareness or other activities arrange by the schools, so that&#xD;
           the mothers refrain from social isolation and rebuild their self esteem.&#xD;
&#xD;
           Every month a psychiatrist of NIMH, B will visit each school for reviewing the records&#xD;
           maintained by the psychologist and provide necessary advice to the psychologist for&#xD;
           additional care of the depressed mother as and when required. The psychiatrist will&#xD;
           reassess the additional need of a mother following face to face consultation if&#xD;
           suggested by the record review, or identified by the psychologist. The medical care will&#xD;
           specially focus on management of depression with varying degree of severity as listed&#xD;
           below, including care for common mental disorders (neurosis), if exists. Mothers will be&#xD;
           referred to the National Institute of Mental Health for providing advanced mental health&#xD;
           care if necessary and be provided with free medicines that are available at the NIMH&#xD;
           including anti- depressant, anxio-lytic, anti-psychotic etc.&#xD;
&#xD;
           The medical care will follow the management guideline adopted in NIMH for treating the&#xD;
           following conditions, including referral to the National Institute of Mental Health for&#xD;
           advanced mental health care if necessary.&#xD;
&#xD;
           If mild to moderate: field psychologist: counseling and Cognitive behavior therapy.&#xD;
&#xD;
           If moderate to severe (without suicidal tendency): Counseling and Cognitive behavior&#xD;
           therapy. Drugs prescribed by psychiatrists during the periodical visits at the school.&#xD;
           If mothers have a suicidal tendency she will be immediately referred to NIMH or other&#xD;
           collaborative institutes. For other psychiatric disorders, such as, major mental&#xD;
           disorder or psychosis), the psychiatrist will prescribe drugs during their periodic&#xD;
           visits and refer a mother to NIMH or any other hospital that a mothers prefers, if fund&#xD;
           necessary by the discretion of the psychiatrist.&#xD;
&#xD;
        2. Organizing training of the intervention mothers in the schools for supporting child care&#xD;
           at home A parental training module was developed in the local language (Bangla) by&#xD;
           icddr,b led by Naheed et al in 2015 and customized according to the local context under&#xD;
           the guidance of an Expert Working Group comprised of experts in various relevant&#xD;
           disciplines. The module was piloted with 56 parents and validated for its application in&#xD;
           the local setting. Investigator will deploy one special educator at each school who will&#xD;
           organize structured training sessions for the intervention mothers by using BCC&#xD;
           materials. The special educator will conduct multiple group sessions including 5-8&#xD;
           mothers in each group for covering the 6 modules over 2 weeks time. The special&#xD;
           educators will follow up with mothers at home every month for conducting refresher's&#xD;
           training and document the need of additional training supports for an individual child&#xD;
           as advised by the mother or observed by the educator herself. The special educator will&#xD;
           consult with one of the Co Investigators who is an ASD expert and incorporate necessary&#xD;
           aids or additional training for a specific child as advised by the expert, and link&#xD;
           mother with the ASD expert for helping mothers taking a decision.&#xD;
&#xD;
      Estimating the cost of the pilot intervention&#xD;
&#xD;
      The project will estimate the overall costs that would incur to an individual institution due&#xD;
      to introduction of the combined services at the school. As such, research staff will track&#xD;
      costs of mental health services throughout the intervention period of 6 months and cost of&#xD;
      conducting training of mothers at school over 4 months period. Costs related to mental health&#xD;
      services will include counseling sessions, psychiatrists' visits, facility, training, special&#xD;
      educators, training materials and any other cost that might be potentially borne by the&#xD;
      institutions.&#xD;
&#xD;
      Stage 3:&#xD;
&#xD;
      This will also include a qualitative end line survey conducted with the intervention mothers,&#xD;
      special educators, psychologists, psychiatrists and principals of the school who would be&#xD;
      involved with implementing the intervention and participated in the baseline qualitative&#xD;
      survey. The end line qualitative survey will assess views of various stakeholders about the&#xD;
      directions for institutionalizing the proposed intervention based on their experiences in the&#xD;
      intervention, particularly aligned with the barriers documented during the intervention&#xD;
      period. Research staff will also conduct an end assessment of current major depressive&#xD;
      episode (MDE) among all mothers in the selected schools including the mothers participated in&#xD;
      the intervention, and assess the performance level and degree of ASD in their children to&#xD;
      assess the impact of the training module.&#xD;
&#xD;
      Survey for the maternal depression&#xD;
&#xD;
      Inclusion criteria:&#xD;
&#xD;
        1. Managers, special educators, psychologists, therapists, depressed mothers, and family&#xD;
           members of the depressed mothers&#xD;
&#xD;
        2. Psychiatrists, Pediatricians, medical doctors, working in the collaborating medical&#xD;
           institutions who are involved with ASD care.&#xD;
&#xD;
        3. Parents of children with ASD enrolled in other schools that offer ASD services.&#xD;
&#xD;
        4. Policy makers who are involved in the Ministry of Health, the Ministry of Family&#xD;
           Welfare, Autism cell etc. for developing the national strategic plan and policies for&#xD;
           strengthening ASD care in Bangladesh. .&#xD;
&#xD;
      Exclusion Criteria:&#xD;
&#xD;
        1. Participants who are too ill to commute&#xD;
&#xD;
        2. Participants who are mentally compromised to give a voluntary consent for her own.&#xD;
&#xD;
      Research staff will conduct in depth interviews with the above listed participants for&#xD;
      assessing barriers of implementing the intervention at institutional level, individual level,&#xD;
      family level, provider level, policy makers level and at the level of the state prior to&#xD;
      intervention.&#xD;
&#xD;
      Intervention Phase:&#xD;
&#xD;
      Inclusion criteria:&#xD;
&#xD;
      Psychologists will identify those mothers who would be diagnosed as having a current major&#xD;
      depressive episode (MDE) at the baseline survey as assessed by PHQ-9 and SCID, and willing to&#xD;
      participate in the intervention for the next 6 months.&#xD;
&#xD;
      Exclusion Criteria:&#xD;
&#xD;
      Any mother diagnosed as having a severe forms of depression with any suicidal ideation or&#xD;
      unsafe thoughts will be referred for urgent hospital based mental health services in the&#xD;
      community (as per standard of care and ethical obligations), and will not be invited to&#xD;
      participate in the study or will be withdrawn from the study if such a condition develops in&#xD;
      the course of intervention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 1, 2017</start_date>
  <completion_date type="Anticipated">September 2021</completion_date>
  <primary_completion_date type="Anticipated">September 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Participants who can accept, afford and adapt the implemented program of mental health service and home based training program</measure>
    <time_frame>6 months</time_frame>
    <description>assessed by qualitative guideline thorough IDI, KII</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of mothers with Major Depressive Disorder (MDD)</measure>
    <time_frame>6 months</time_frame>
    <description>assessed by SCID-I</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of children with ASD who have improved their skill in terms of communication, behavior and social skills</measure>
    <time_frame>6 months</time_frame>
    <description>assessed by ADCL (ASD Diagnostic Check-list)</description>
  </secondary_outcome>
  <enrollment type="Anticipated">78</enrollment>
  <condition>Maternal Depression</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Mental Health care services &amp; home based training</intervention_name>
    <description>From day 0 of the study period we will initiate setting up the intervention in two schools, which will include two components:&#xD;
Implementing mental health care services at schools targeting the mothers diagnosed as having depression who have consented to participate in the study (intervention mother).&#xD;
Psychologists will provide counseling session over 4-6 months period. Every month a psychiatrist will visit each school for reviewing the records of the mothers and mothers will be referred to the National Institute of Mental Health (NIMH) if necessary&#xD;
Organizing training sessions of the intervention mothers for supporting enhanced child care at home.&#xD;
Organizing training of the intervention mothers by special educator through a parental training module in the schools. Special educator will conduct refresher training at home every month.</description>
    <other_name>psycho social management</other_name>
    <other_name>home based training program</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Survey for the maternal depression&#xD;
&#xD;
        Inclusion criteria:&#xD;
&#xD;
          1. Managers, special educators, psychologists, therapists, depressed mothers, and family&#xD;
             members of the depressed mothers&#xD;
&#xD;
          2. Psychiatrists, Pediatricians, medical doctors, working in the collaborating medical&#xD;
             institutions who are involved with ASD care.&#xD;
&#xD;
          3. Parents of children with ASD enrolled in other schools that offer ASD services.&#xD;
&#xD;
          4. Policy makers who are involved in the Ministry of Health, the Ministry of Family&#xD;
             Welfare, Autism cell etc. for developing the national strategic plan and policies for&#xD;
             strengthening ASD care in Bangladesh.&#xD;
&#xD;
        Intervention Phase:&#xD;
&#xD;
        Inclusion criteria:&#xD;
&#xD;
        We will identify those mothers who would be diagnosed as having a current major depressive&#xD;
        episode (MDE) at the baseline survey as assessed by PHQ-9 and SCID, and willing to&#xD;
        participate in the intervention for the next 6 months.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Survey for the maternal depression&#xD;
&#xD;
          1. Participants who are too ill to commute&#xD;
&#xD;
          2. Participants who are mentally compromised to give a voluntary consent for her own.&#xD;
&#xD;
        Intervention Phase:&#xD;
&#xD;
        Any mother diagnosed as having a severe forms of depression with any suicidal ideation or&#xD;
        unsafe thoughts will be referred for urgent hospital based mental health services in the&#xD;
        community (as per standard of care and ethical obligations), and will not be invited to&#xD;
        participate in the study or will be withdrawn from the study if such a condition develops&#xD;
        in the course of intervention.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Kamrun Nahar Koly, MBBS, MPH</last_name>
    <phone>01717190955</phone>
    <email>koly@icddrb.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Aliya Naheed, MBBS (DU), MPH (JHU), PhD (TU)</last_name>
    <phone>01709651476</phone>
    <phone_ext>2521</phone_ext>
    <email>anaheed@icddrb.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Awf, Swac</name>
      <address>
        <city>Dhaka</city>
        <zip>1214</zip>
        <country>Bangladesh</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Bangladesh</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>January 2, 2017</study_first_submitted>
  <study_first_submitted_qc>January 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 19, 2017</study_first_posted>
  <last_update_submitted>April 23, 2021</last_update_submitted>
  <last_update_submitted_qc>April 23, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 26, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Maternal depression</keyword>
  <keyword>ASD</keyword>
  <keyword>Home based training program</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</mesh_term>
    <mesh_term>Autism Spectrum Disorder</mesh_term>
  </condition_browse>
  <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/NCT03025646
org study id: PR-16070
nct id: NCT03025646
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Background (brief):

      The global burden of depression accounts for 2.5% of global DALYs, and in South Asia the
      estimate is 13.3 % of DALYs per 100,000 populations. Mothers of children with Autism Spectrum
      Disorder (ASD) have reported higher level of depression than mothers of children with other
      developmental disorder and the prevalence of ASD is high in Asian countries. In Bangladesh
      16% of adults suffer from depression and a recent study conducted in Bangladesh has
      documented a high prevalence of depression among mothers of children with ASD (45%). Mothers
      are the life time care givers of children with ASD, and a high burden of depression is likely
      negatively impact on the ability of the mothers to provide care to children at home. Mental
      health is not addressed in Bangladesh and there is scarcity of qualified providers.

      Objectives:

      The investigators propose to pilot the feasibility of a package intervention including
      implementation of mental health care and home based training program for the mothers of
      children with ASD integrated in the regular activities of the special schools that offer ASD
      care in Dhaka city in Bangladesh.

      Methods:

      The study will be conducted in 2 selected special schools over 15 months. In the first stage,
      the investigators will set up the study in two schools and identify various stakeholders for
      qualitative assessment of the barriers of implementing the intervention at the institutional
      level, individual level, family level, provider level, policy maker level and at the level of
      the state. Research staff will identify mothers 18 years of age or older who has a child with
      ASD between 3 and 17 years of age enrolled in the school. Following consent, data collector
      will obtain data and assess current major depressive episode (MDE) of the eligible mothers
      following a standard diagnostic tool (SCID-I). All mothers diagnosed as having MDE will be
      invited to participate in the intervention (intervention mothers) and the investigators will
      assess the performances in children with ASD by applying ASD Diagnostic Check-list (ADCL).

      In the second stage, investigators will implement interventions over 4-6 months, including
      (a) implementing mental health care services at the selected schools targeting the
      intervention mothers, and (b) organizing training sessions of the intervention mothers for
      supporting child care at home for enhancing child performances. Every month a psychiatrist
      will visit each school for providing necessary advice and treatment to the intervention
      mothers or suggest referral to hospital care, if necessary.

      One special educator will be deployed at each school who will organize structured training
      sessions for educating the intervention mothers by using BCC materials developed and
      validated by icddr,b in the local setting. The special educators will conduct multiple group
      sessions including 5-8 mothers in each group for covering the 6 modules over 2 weeks time,
      and follow up intervention mothers at home every month for conducting refresher's training,
      documenting the need of additional training supports, and linking mother with an ASD expert
      for helping mothers taking a decision.

      In stage 3, investigators will conduct post intervention qualitative survey with various
      stakeholders who would be involved with implementing the intervention and participated in the
      baseline qualitative survey. End line assessment will be conducted of current major
      depressive episode (MDE) among all mothers and assess the performance of the children of
      intervention mothers in order to assess the impact of the training at home.

      Outcome measures/variables:

      The primary outcome of the study is to assess the feasibility of institutionalizing the
      combined intervention of mental health care supports and the home based training program of
      the mothers who would be diagnosed as having major current major depressive episode. The
      primary outcome will be assessed by obtaining the perspectives of various stakeholders. The
      following parameters will be assessed for measuring feasibility of the proposed intervention.

      Acceptability, Adaptability, Demands, Practicality, Implementation, Integration

      The secondary outcomes will include estimating the impact of the combined interventions on
      the prevalence rate of maternal depression (MDE), individual performances of children, and
      cost of intervention. Adaptation of the proposed strategy, if feasible will help the mothers
      of children with ASD become skilled workforces for filling in the gap of the special
      educators in resource poor settings, and extension of these services to more children with
      ASD.
The study will be conducted in 2 selected special schools in Dhaka city, (i) Autiam welfare
      Foundation (AWF: http://awfbd.com/) and (ii) Society for the Welfare of Autistic Children
      (SWAC: http://www.ASDbd.com/swac-bd/) who have more than 10 years of experiences with
      offering quality services for ASD care in Bangladesh. The investigator will conduct the study
      in both schools in 3 stages:

        -  Preparatory phase and baseline assessment (stage 1)

        -  Implementation of intervention (stage 2)

        -  End line assessment (stage 3)

      Stage 1:

      The investigator will set up the study in two schools and identify various stakeholders
      including the managers of the schools, special educators, psychologists, psychiatrists,
      medical doctors, parent of children with ASD, policy makers etc. Data collector will obtain
      written const from them and conduct in depth interviews for assessing barriers of
      implementing the intervention at institutional level, individual level, family level,
      provider level, policy makers level and at the level of the state prior to intervention.

      Research staff will identify those mothers who are at least 18 years of age and has a child
      with ASD between 3 and 17 years of age enrolled in the school. The staff in the intervention
      phase would not be involved in the baseline or end line surveys. The investigator will
      recruit separate staff for conducting baseline and end line surveys. Data collector will
      obtain additional school based information regarding the children's ASD diagnosis and an
      expert from IPNA will reconfirm their ASD by ADCL in order to further validate and rate the
      ASD diagnoses with health and education related information.

      Data collector will obtain written consent from the eligible mothers who have child with ASD
      and obtain essential socio demographic and other relevant data, and perform clinical
      diagnosis of major depressive disorder (MDD) and current major depressive episode (MDE)
      following a standard diagnostic tool (SCID-I) based on DSM-IV criteria as it has already been
      validated through several studies in Bangladesh. All mothers diagnosed as having MDE will be
      invited to participate in the intervention following a written consent (intervention
      mothers). However, any mother identified with severe forms of depression with any suicidal
      ideation or unsafe thoughts will be referred for urgent hospital based mental health services
      in the community (as per standard of care and ethical obligations), and they will not be
      invited to participate in the study. The selected schools would have at least 100-150
      children with ASD enrolled in a given year, and we anticipate that a total of ~ 54 to 80
      mothers will participate in the intervention. Data collector will interview the intervention
      mothers in order to assess the individual performances of their children by using a standard
      tool ADCL (ASD Diagnostic Check-list). ADCL is a standard tool applied by ASD experts in
      Bangladesh to track improvement in performances in children with ASD [22].This tool comprises
      of 60 items focusing on 6 major areas of ASD, including (i) General Observation (13 items),
      (ii) Cognition (10 items), (iii) Emotion (8 items), (iv) Social/Self Help (8 items), (v)
      Communication (12 items), and (vi) Sensory deficiency (9 items).

      Stage 2:

      From day 0 of the study period investigator will initiate setting up the intervention in two
      schools, which will include two components; (a) Implementing mental health care services at
      schools targeting the mothers diagnosed as having depression who have consented to
      participate in the study (intervention mother) and (b) Organizing training sessions of the
      intervention mothers for supporting enhanced child care at home. Although the mental health
      services will target mothers who would volunteer to participate in the intervention. The
      proposed intervention will be implemented over 4-6 months period; the two components of the
      package have been described below in details.

        1. . Implementing mental health care services at school

           The investigator will develop a counseling centre at each school by deploying one
           trained female psychologists who would provide counseling to the intervention mothers.
           Investigator will adopt the psychological management procedures that have been commonly
           administered by the experts of National Institute of Mental Health, Bangladesh (NIMH,
           B). Intervention guidelines will be submitted to ERC for reviewing and necessary
           approval of the document before the final application in the study. The mental health
           services counseling module will comprises of the following topics:

             1. Psycho education

                Psycho education refers to the education offered to individuals with a mental
                health condition and their families to help empower them and deal with their
                condition in an optimal way. Psycho education will be given by a trained
                psychologists under the guidance of a psychiatrists to increase the self esteem of
                the mothers, which will include the brief concept on depression, the probable
                etiology, how to mitigate the symptoms, compliance to the therapeutic process and
                the consequences. This method of psychological management is commonly practiced by
                the psychologists and also has been used in the former studies in Bangladesh.

             2. Assessment of the strength and weakness of the mothers

                The psychologists will assess the strengths and weakness of the mothers, and
                discover their personal obstacles, issues that might hinder their progress in terms
                of social context, family support, financial state, educational qualification,
                empowerment etc.

             3. Sharing the management plan with the mothers The psychologists will share the whole
                management processes with the mothers and any opinion from the mother could be a
                part of the management. The goal is to empower mothers and include them as a part
                of the management team counseling other mothers.

             4. Reconstruction of the cognition Cognitive restructuring is a psychotherapeutic
                process of learning to identify and dispute irrational or maladaptive thoughts
                known as cognitive distortions. It is a core part of Cognitive Behavioral Therapy
                (CBT). CBT is a structured method and one of the most effective psychological
                treatments commonly used by the psychiatrists and psychologists of Bangladesh to
                intervene depression. To manage depression minimum 12 sessions are required which
                can be more upon the severity of the clients. CBT mainly deals with exploring
                problems, thoughts, feelings and behavior of the clients. It is one of the major
                components of our intervention protocol based on the standard practice of the
                experts of Bangladesh.

             5. Behavior therapy- graded activity Graded activity is a principle of therapeutic
                intervention in which tasks are classified and gradually presented according to the
                client's level of function and the challenge or degree of skill (physical, social,
                or cognitive) required by the task. In this study after assessing the strengths and
                weaknesses of the mothers their functional activity also be monitored and will try
                to increase. The graded activity starts from personal care, daily household
                activities, child care, engagement in small and easy tasks and complex and
                productive tasks.

             6. Developing a mother's community and engaging depressed mothers in community related
                activities

           The psychologist will arrange a workshop in each participating school at two months
           interval for enabling mothers meet other mothers in the intervention and create a common
           platform where they can share their experiences , success stories and encourage a
           positive reinforcement on the depressed mothers. The mothers will be encouraged to
           participate in the social awareness or other activities arrange by the schools, so that
           the mothers refrain from social isolation and rebuild their self esteem.

           Every month a psychiatrist of NIMH, B will visit each school for reviewing the records
           maintained by the psychologist and provide necessary advice to the psychologist for
           additional care of the depressed mother as and when required. The psychiatrist will
           reassess the additional need of a mother following face to face consultation if
           suggested by the record review, or identified by the psychologist. The medical care will
           specially focus on management of depression with varying degree of severity as listed
           below, including care for common mental disorders (neurosis), if exists. Mothers will be
           referred to the National Institute of Mental Health for providing advanced mental health
           care if necessary and be provided with free medicines that are available at the NIMH
           including anti- depressant, anxio-lytic, anti-psychotic etc.

           The medical care will follow the management guideline adopted in NIMH for treating the
           following conditions, including referral to the National Institute of Mental Health for
           advanced mental health care if necessary.

           If mild to moderate: field psychologist: counseling and Cognitive behavior therapy.

           If moderate to severe (without suicidal tendency): Counseling and Cognitive behavior
           therapy. Drugs prescribed by psychiatrists during the periodical visits at the school.
           If mothers have a suicidal tendency she will be immediately referred to NIMH or other
           collaborative institutes. For other psychiatric disorders, such as, major mental
           disorder or psychosis), the psychiatrist will prescribe drugs during their periodic
           visits and refer a mother to NIMH or any other hospital that a mothers prefers, if fund
           necessary by the discretion of the psychiatrist.

        2. Organizing training of the intervention mothers in the schools for supporting child care
           at home A parental training module was developed in the local language (Bangla) by
           icddr,b led by Naheed et al in 2015 and customized according to the local context under
           the guidance of an Expert Working Group comprised of experts in various relevant
           disciplines. The module was piloted with 56 parents and validated for its application in
           the local setting. Investigator will deploy one special educator at each school who will
           organize structured training sessions for the intervention mothers by using BCC
           materials. The special educator will conduct multiple group sessions including 5-8
           mothers in each group for covering the 6 modules over 2 weeks time. The special
           educators will follow up with mothers at home every month for conducting refresher's
           training and document the need of additional training supports for an individual child
           as advised by the mother or observed by the educator herself. The special educator will
           consult with one of the Co Investigators who is an ASD expert and incorporate necessary
           aids or additional training for a specific child as advised by the expert, and link
           mother with the ASD expert for helping mothers taking a decision.

      Estimating the cost of the pilot intervention

      The project will estimate the overall costs that would incur to an individual institution due
      to introduction of the combined services at the school. As such, research staff will track
      costs of mental health services throughout the intervention period of 6 months and cost of
      conducting training of mothers at school over 4 months period. Costs related to mental health
      services will include counseling sessions, psychiatrists' visits, facility, training, special
      educators, training materials and any other cost that might be potentially borne by the
      institutions.

      Stage 3:

      This will also include a qualitative end line survey conducted with the intervention mothers,
      special educators, psychologists, psychiatrists and principals of the school who would be
      involved with implementing the intervention and participated in the baseline qualitative
      survey. The end line qualitative survey will assess views of various stakeholders about the
      directions for institutionalizing the proposed intervention based on their experiences in the
      intervention, particularly aligned with the barriers documented during the intervention
      period. Research staff will also conduct an end assessment of current major depressive
      episode (MDE) among all mothers in the selected schools including the mothers participated in
      the intervention, and assess the performance level and degree of ASD in their children to
      assess the impact of the training module.

      Survey for the maternal depression

      Inclusion criteria:

        1. Managers, special educators, psychologists, therapists, depressed mothers, and family
           members of the depressed mothers

        2. Psychiatrists, Pediatricians, medical doctors, working in the collaborating medical
           institutions who are involved with ASD care.

        3. Parents of children with ASD enrolled in other schools that offer ASD services.

        4. Policy makers who are involved in the Ministry of Health, the Ministry of Family
           Welfare, Autism cell etc. for developing the national strategic plan and policies for
           strengthening ASD care in Bangladesh. .

      Exclusion Criteria:

        1. Participants who are too ill to commute

        2. Participants who are mentally compromised to give a voluntary consent for her own.

      Research staff will conduct in depth interviews with the above listed participants for
      assessing barriers of implementing the intervention at institutional level, individual level,
      family level, provider level, policy makers level and at the level of the state prior to
      intervention.

      Intervention Phase:

      Inclusion criteria:

      Psychologists will identify those mothers who would be diagnosed as having a current major
      depressive episode (MDE) at the baseline survey as assessed by PHQ-9 and SCID, and willing to
      participate in the intervention for the next 6 months.

      Exclusion Criteria:

      Any mother diagnosed as having a severe forms of depression with any suicidal ideation or
      unsafe thoughts will be referred for urgent hospital based mental health services in the
      community (as per standard of care and ethical obligations), and will not be invited to
      participate in the study or will be withdrawn from the study if such a condition develops in
      the course of intervention.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Participants who can accept, afford and adapt the implemented program of mental health service and home based training program
time frame: 6 months
description: assessed by qualitative guideline thorough IDI, KII
measure: Number of mothers with Major Depressive Disorder (MDD)
time frame: 6 months
description: assessed by SCID-I
measure: Number of children with ASD who have improved their skill in terms of communication, behavior and social skills
time frame: 6 months
description: assessed by ADCL (ASD Diagnostic Check-list)
intervention type: Other
intervention name: Mental Health care services & home based training
description: From day 0 of the study period we will initiate setting up the intervention in two schools, which will include two components:
Implementing mental health care services at schools targeting the mothers diagnosed as having depression who have consented to participate in the study (intervention mother).
Psychologists will provide counseling session over 4-6 months period. Every month a psychiatrist will visit each school for reviewing the records of the mothers and mothers will be referred to the National Institute of Mental Health (NIMH) if necessary
Organizing training sessions of the intervention mothers for supporting enhanced child care at home.
Organizing training of the intervention mothers by special educator through a parental training module in the schools. Special educator will conduct refresher training at home every month.
other name: psycho social management
other name: home based training program
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
last name: Kamrun Nahar Koly, MBBS, MPH
phone: 01717190955
email: koly@icddrb.org
last name: Aliya Naheed, MBBS (DU), MPH (JHU), PhD (TU)
phone: 01709651476
phone ext: 2521
email: anaheed@icddrb.org
facility: 
status: Recruiting
country: Bangladesh
responsible party type: Sponsor
mesh term: Depression
mesh term: Autism Spectrum Disorder
sharing ipd: No