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
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03025646|
Recruitment Status : Recruiting
First Posted : January 19, 2017
Last Update Posted : April 26, 2021
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.
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.
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.
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.
|Condition or disease||Intervention/treatment||Phase|
|Maternal Depression||Other: Mental Health care services & home based training||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||78 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|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|
|Actual Study Start Date :||April 1, 2017|
|Estimated Primary Completion Date :||September 2021|
|Estimated Study Completion Date :||September 2021|
- Other: Mental Health care services & home based training
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 Names:
- psycho social management
- home based training program
- Participants who can accept, afford and adapt the implemented program of mental health service and home based training program [ Time Frame: 6 months ]assessed by qualitative guideline thorough IDI, KII
- Number of mothers with Major Depressive Disorder (MDD) [ Time Frame: 6 months ]assessed by SCID-I
- Number of children with ASD who have improved their skill in terms of communication, behavior and social skills [ Time Frame: 6 months ]assessed by ADCL (ASD Diagnostic Check-list)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03025646
|Contact: Kamrun Nahar Koly, MBBS, MPHemail@example.com|
|Contact: Aliya Naheed, MBBS (DU), MPH (JHU), PhD (TU)||01709651476 ext firstname.lastname@example.org|
|Dhaka, Bangladesh, 1214|