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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

This study is not yet open for participant recruitment.
See Contacts and Locations
Verified November 2016 by International Centre for Diarrhoeal Disease Research, Bangladesh
Sponsor:
Collaborators:
Harvard Medical School
National Institute of Mental Health (NIMH)
National Institute of Neurosciences Hospital (NINS)
Institute of Paediatric Neurodisorder and Autism (IPNA)
Information provided by (Responsible Party):
International Centre for Diarrhoeal Disease Research, Bangladesh
ClinicalTrials.gov Identifier:
NCT03025646
First received: January 2, 2017
Last updated: January 18, 2017
Last verified: November 2016
  Purpose

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.


Condition Intervention
Maternal Depression Other: Mental Health care services & home based training

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: No masking
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

Resource links provided by NLM:


Further study details as provided by International Centre for Diarrhoeal Disease Research, Bangladesh:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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)


Estimated Enrollment: 78
Study Start Date: January 2017
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Intervention Details:
    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:

    1. 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

    2. 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
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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.

Intervention Phase:

Inclusion criteria:

We 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:

Survey for the maternal depression

  1. Participants who are too ill to commute
  2. Participants who are mentally compromised to give a voluntary consent for her own.

Intervention Phase:

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03025646

Contacts
Contact: Kamrun Nahar Koly, MBBS, MPH 01717190955 koly@icddrb.org
Contact: Aliya Naheed, MBBS (DU), MPH (JHU), PhD (TU) 01709651476 ext 2521 anaheed@icddrb.org

Sponsors and Collaborators
International Centre for Diarrhoeal Disease Research, Bangladesh
Harvard Medical School
National Institute of Mental Health (NIMH)
National Institute of Neurosciences Hospital (NINS)
Institute of Paediatric Neurodisorder and Autism (IPNA)
  More Information

Responsible Party: International Centre for Diarrhoeal Disease Research, Bangladesh
ClinicalTrials.gov Identifier: NCT03025646     History of Changes
Other Study ID Numbers: PR-16070
Study First Received: January 2, 2017
Last Updated: January 18, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by International Centre for Diarrhoeal Disease Research, Bangladesh:
Maternal depression
ASD
Home based training program

Additional relevant MeSH terms:
Depression
Autism Spectrum Disorder
Behavioral Symptoms
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 25, 2017