Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT03025646 |
| Other study ID # |
PR-16070 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 1, 2017 |
| Est. completion date |
September 2021 |
Study information
| Verified date |
February 2021 |
| Source |
International Centre for Diarrhoeal Disease Research, Bangladesh |
| Contact |
Kamrun Nahar Koly, MBBS, MPH |
| Phone |
01717190955 |
| Email |
koly[@]icddrb.org |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
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.
