Effect of Community Based Depression Management and Child Development
NCT ID: NCT02719054
Last Updated: 2016-03-25
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
300 participants
Study Classification
INTERVENTIONAL
Study Start Date
2014-01-31
Study Completion Date
2015-12-31
Brief Summary
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Investments in Early childhood Development (ECD) programs produce higher economic return through maximizing human potential. In developing countries over 200 million children do not reach their developmental potential. Early nutritional support and psycho social stimulation are essential for optimum development of children. Mothers are usually the key providers of childcare.
Depression is reported as a leading cause of disease burden for women and maternal mental health is identified as one of the major predictors of child development.
In Bangladesh, almost 60% children are at risk of poor development due to high prevalence of Low Birth Weight (22%), under nutrition (41%), poverty, and sub-optimal stimulation. About one third of Bangladeshi mothers suffer from depression. Early stimulation interventions in Bangladesh have showed moderate improvements to children's development. This indicates that there are still some gaps in the pathway to delivery. So, it is crucially important to address maternal mental health along with any Early Childhood Development intervention at community level to get bigger impact.
In Bangladesh mothers with sub clinical depressive symptoms often do not seek treatment due to the stigma attached to it. Depressed mothers who do not receive treatment often fail to provide sufficient stimulation and care for their children and in turn compromise benefits of early stimulation programs. Rahman and colleagues (2008) tested an innovative model of community-based depression management using Cognitive Behavioral Therapy in Pakistan and reported improvement in maternal depression 6 months postpartum.
The study plans to combine the above treatment of depression with an evidenced-based Early Childhood Development program to achieve maximum benefits on reducing maternal depressive symptoms as well as improving children's overall development.
Depression is reported as a leading cause of disease burden for women and maternal mental health is identified as one of the major predictors of child development.
In Bangladesh, almost 60% children are at risk of poor development due to high prevalence of Low Birth Weight (22%), under nutrition (41%), poverty, and sub-optimal stimulation. About one third of Bangladeshi mothers suffer from depression. Early stimulation interventions in Bangladesh have showed moderate improvements to children's development. This indicates that there are still some gaps in the pathway to delivery. So, it is crucially important to address maternal mental health along with any Early Childhood Development intervention at community level to get bigger impact.
In Bangladesh mothers with sub clinical depressive symptoms often do not seek treatment due to the stigma attached to it. Depressed mothers who do not receive treatment often fail to provide sufficient stimulation and care for their children and in turn compromise benefits of early stimulation programs. Rahman and colleagues (2008) tested an innovative model of community-based depression management using Cognitive Behavioral Therapy in Pakistan and reported improvement in maternal depression 6 months postpartum.
The study plans to combine the above treatment of depression with an evidenced-based Early Childhood Development program to achieve maximum benefits on reducing maternal depressive symptoms as well as improving children's overall development.
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Detailed Description
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Present study proposes to conduct the study in rural areas covered by community clinic (CC) services and will use their community based staff to deliver the intervention. Each Community Clinic is established at grass root level providing one stop service center for Primary Health Care for approx. 6000 population. There are over 12000 Community Clinics operating in Bangladesh. We chose this population as almost 75% of people live in rural areas and they will form a representative sample for scaling in future. There will be 2 groups in the study i) Intervention group (Cognitive Behavioral Therapy + play stimulation) and ii) control group (with none)..
Previous studies reported moderate benefit with both home and center based psycho social stimulation program in Bangladesh. However in most parts we found low self esteem among the mothers that required quite effort to bring them into the task. So it is assumed that the proposed community based Cognitive Behavioral Therapy model (Rahman et al 2008) for management of depressive symptoms, will be a unique sustainable approach to get maximize effect psycho social stimulation intervention. The study aimed to deliver the intervention using government health infrastructure. The study will evaluate the workload of existing 2 staff -Health Assistant (HA) and Family Welfare Assistant (FWA) at each Community Clinic who regularly go for home visits and will train them for intervention. The study may need to train one additional person from the same community to assist Health Assistant or Family Welfare Assistant in delivering the intervention. The overall success of the project will be able to come up with a model that can be used by other Community Clinics to take it to scale.
After selection of study sites under 30 Community Clinics, randomization will be done. The study will do several small group discussions with mothers living in those communities to know about their lifestyle, local terminologies of depressive symptoms, view about depressive symptoms, child rearing practices and coping strategies. Then Health Assistants and Family Welfare Assistants of 15 intervention Community Clinics will be identified and will receive training in batches. In next step, after taking consent, screening will be conducted in the community among mothers of 9-12 months old children by trained psychologists. Considering the Community Clinics as a center, data collectors will start screening from center to periphery in the community until we get 10 mothers with depressive symptoms. Mothers, who will fulfill the study enrollment criteria, will be offered to join the study and will be invited to the test center for baseline assessment (of mother-child dyad). We will set up temporary test centers in villages under each Community Clinic, using a space in Community Clinics (provided there is available space) or rooms in schools or convenient rented rooms in residence of local people. Two teams of testers and interviewers will be rotated from one Community Clinic to another after completing screening and baseline psychological assessments in areas under that Community Clinic which on average would take 2-3 days. It is expected that the baseline assessment will be covered by 2 months. Soon after baseline assessment in one Community Clinic, intervention in villages under that Community Clinic will be started by the trained Health Assistant/Family Welfare Assistant assigned to that Community Clinic. In the middle of the study, the study will conduct in-depth interview on two mothers under each Community Clinic to know about mothers' perception and comments about the intervention for further modification of the program. The study will also conduct small group discussions with the Health Assistant and Family Welfare Assistant about the intervention during monthly meetings with them- to know their views about the program. After 12 months intervention, final assessment will be done following the same procedure"
Previous studies reported moderate benefit with both home and center based psycho social stimulation program in Bangladesh. However in most parts we found low self esteem among the mothers that required quite effort to bring them into the task. So it is assumed that the proposed community based Cognitive Behavioral Therapy model (Rahman et al 2008) for management of depressive symptoms, will be a unique sustainable approach to get maximize effect psycho social stimulation intervention. The study aimed to deliver the intervention using government health infrastructure. The study will evaluate the workload of existing 2 staff -Health Assistant (HA) and Family Welfare Assistant (FWA) at each Community Clinic who regularly go for home visits and will train them for intervention. The study may need to train one additional person from the same community to assist Health Assistant or Family Welfare Assistant in delivering the intervention. The overall success of the project will be able to come up with a model that can be used by other Community Clinics to take it to scale.
After selection of study sites under 30 Community Clinics, randomization will be done. The study will do several small group discussions with mothers living in those communities to know about their lifestyle, local terminologies of depressive symptoms, view about depressive symptoms, child rearing practices and coping strategies. Then Health Assistants and Family Welfare Assistants of 15 intervention Community Clinics will be identified and will receive training in batches. In next step, after taking consent, screening will be conducted in the community among mothers of 9-12 months old children by trained psychologists. Considering the Community Clinics as a center, data collectors will start screening from center to periphery in the community until we get 10 mothers with depressive symptoms. Mothers, who will fulfill the study enrollment criteria, will be offered to join the study and will be invited to the test center for baseline assessment (of mother-child dyad). We will set up temporary test centers in villages under each Community Clinic, using a space in Community Clinics (provided there is available space) or rooms in schools or convenient rented rooms in residence of local people. Two teams of testers and interviewers will be rotated from one Community Clinic to another after completing screening and baseline psychological assessments in areas under that Community Clinic which on average would take 2-3 days. It is expected that the baseline assessment will be covered by 2 months. Soon after baseline assessment in one Community Clinic, intervention in villages under that Community Clinic will be started by the trained Health Assistant/Family Welfare Assistant assigned to that Community Clinic. In the middle of the study, the study will conduct in-depth interview on two mothers under each Community Clinic to know about mothers' perception and comments about the intervention for further modification of the program. The study will also conduct small group discussions with the Health Assistant and Family Welfare Assistant about the intervention during monthly meetings with them- to know their views about the program. After 12 months intervention, final assessment will be done following the same procedure"
Conditions
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Maternal Depressive Symptom and Child Development
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
PREVENTION
Blinding Strategy
NONE
Study Groups
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stimulation
Cognitive behavioral therapy for mother and play stimulation for children aged 6 to 12 months
Group Type
EXPERIMENTAL
Cognitive behavioral therapy: Alter of negative thinking, positive thinking and social support and psychosocial stimulation: play stimulation and parenting
Intervention Type
BEHAVIORAL
A:Cognitive Behavioral Therapy specifically focused on "changing thinking style toward positive" and not associated with any medication. CBT found to be effective in managing or treating not only depression, also a variety of other conditions-e.g. mood, personality, stress, eating habit, tic etc.
B: Psycho social stimulation will follow a set of culturally appropriate, semi-structured, child's age appropriate curriculum.
Mother child dyad
Group Type
NO_INTERVENTION
No interventions assigned to this group
Interventions
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Cognitive behavioral therapy: Alter of negative thinking, positive thinking and social support and psychosocial stimulation: play stimulation and parenting
A:Cognitive Behavioral Therapy specifically focused on "changing thinking style toward positive" and not associated with any medication. CBT found to be effective in managing or treating not only depression, also a variety of other conditions-e.g. mood, personality, stress, eating habit, tic etc.
B: Psycho social stimulation will follow a set of culturally appropriate, semi-structured, child's age appropriate curriculum.
Intervention Type
BEHAVIORAL
Other Intervention Names
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CBT & PS
Eligibility Criteria
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Inclusion Criteria
* Mother with depressive symptom( EPDS ≥10) with child aged 6 to 12 months
Exclusion Criteria
* Mother with known severe chronic diseases
* Children with known severe chronic diseases
* Children with known severe chronic diseases
Minimum Eligible Age
6 Months
Maximum Eligible Age
1 Year
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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Bangor University
OTHER
Sponsor Role
collaborator
Institute of Child Health
OTHER
Sponsor Role
collaborator
International Centre for Diarrhoeal Disease Research, Bangladesh
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
References
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Black MM, Baqui AH, Zaman K, McNary SW, Le K, Arifeen SE, Hamadani JD, Parveen M, Yunus M, Black RE. Depressive symptoms among rural Bangladeshi mothers: implications for infant development. J Child Psychol Psychiatry. 2007 Aug;48(8):764-72. doi: 10.1111/j.1469-7610.2007.01752.x.
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Hamadani JD, Huda SN, Khatun F, Grantham-McGregor SM. Psychosocial stimulation improves the development of undernourished children in rural Bangladesh. J Nutr. 2006 Oct;136(10):2645-52. doi: 10.1093/jn/136.10.2645.
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Hamadani JD, Tofail F, Hilaly A, Huda SN, Engle P, Grantham-McGregor SM. Use of family care indicators and their relationship with child development in Bangladesh. J Health Popul Nutr. 2010 Feb;28(1):23-33. doi: 10.3329/jhpn.v28i1.4520.
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Nahar B, Hamadani JD, Ahmed T, Tofail F, Rahman A, Huda SN, Grantham-McGregor SM. Effects of psychosocial stimulation on growth and development of severely malnourished children in a nutrition unit in Bangladesh. Eur J Clin Nutr. 2009 Jun;63(6):725-31. doi: 10.1038/ejcn.2008.44. Epub 2008 Sep 3.
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Tofail F, Persson LA, El Arifeen S, Hamadani JD, Mehrin F, Ridout D, Ekstrom EC, Huda SN, Grantham-McGregor SM. Effects of prenatal food and micronutrient supplementation on infant development: a randomized trial from the Maternal and Infant Nutrition Interventions, Matlab (MINIMat) study. Am J Clin Nutr. 2008 Mar;87(3):704-11. doi: 10.1093/ajcn/87.3.704.
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Tofail F, Hamadani JD, Mehrin F, Ridout DA, Huda SN, Grantham-McGregor SM. Psychosocial stimulation benefits development in nonanemic children but not in anemic, iron-deficient children. J Nutr. 2013 Jun;143(6):885-93. doi: 10.3945/jn.112.160473. Epub 2013 Apr 24.
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Walker SP, Wachs TD, Grantham-McGregor S, Black MM, Nelson CA, Huffman SL, Baker-Henningham H, Chang SM, Hamadani JD, Lozoff B, Gardner JM, Powell CA, Rahman A, Richter L. Inequality in early childhood: risk and protective factors for early child development. Lancet. 2011 Oct 8;378(9799):1325-38. doi: 10.1016/S0140-6736(11)60555-2. Epub 2011 Sep 22.
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Other Identifiers
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PR-13066
Identifier Type: -
Identifier Source: org_study_id
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