Effect of Community Based Depression Management and Child Development

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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

Official Title
-----------------
Effect of Community Based Depression Management and Psychosocial Stimulation Intervention on Maternal Mental Health and Child Development: A Randomized Controlled Trial

Conditions
-----------------
Maternal Depressive Symptom and Child Development

Intervention / Treatment
-----------------
* Behavioral: Cognitive behavioral therapy: Alter of negative thinking, positive thinking and social support and psychosocial stimulation: play stimulation and parenting


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 1 Year

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: stimulation<br>Cognitive behavioral therapy for mother and play stimulation for children aged 6 to 12 months | Behavioral: Cognitive behavioral therapy: Alter of negative thinking, positive thinking and social support and psychosocial stimulation: play stimulation and parenting<br>* 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.<br>* Other names: CBT & PS;|
| No Intervention: Mother child dyad<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child's cognitive, motor and language and behavioral assessment( developmental out come) | Child's cognitive, motor and language assessment using Bayley-III and behavioral assessment during test using Wolke's Behavior Rating Scale. Wolke,s Behavior Rating scale is used through observation during Bayley test. Bayley test includes cognitive, motor and language development. All outcomes will have quantitative scores and results will be made adding the scores. | At base line and change of develomental outcome after one year of intervention at end line | 
| Depressive symptoms | Depression Scores using Edinburgh Postpartum Depression Scale (EPDS) at baseline (during screening at home) and at the end. Result will be made adding score of each questions. | At base line and change of depressive symptomatic outcome after one year of intervention at end line | 
| Mother's self esteem | This will be assessed using adapted version of the Rosenberg Self Esteem Scale, the most widely used measure of self esteem for research purposes. It has been used previously in Bangladesh by our team as a valid instrument. | At base line and change of state of mother's self esteem after one year of intervention at end line | 
| Family Care Indicators | This will be used to measure quality of stimulation the child received at home. FCI has been used in Bangladesh previously and showed good reliabilities | At base line and change of Family Care Indicator after one year of intervention at end line | 
| Child care knowledge and practices | A modified questionnaire based on our previous studies (Hamadani et al. 2006; Nahar et al. 2012) will be given to mothers to assess child care practices. | At base line and change of care giver's child care knowledge and practice after one year of intervention at end line | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Children's height | Children's height at baseline and at the end in test centre. Both the children of control and intervention group may have some medical problems. So as the problems are for the both groups the study results will not be much varied. | At base line and change of children's height after one year of intervention at end line. | 
| Children's weight | Children's weight at baseline and at the end in test centre. Both the children of control and intervention group may have some medical problems. So as the problems are for the both groups the study results will not be much varied. | At base line and change of children's weight after one year of intervention at end line. | 
| Children's Mid Upper Arm Circumference (MUAC) | Children's Mid Upper Arm Circumference (MUAC) at baseline and at the end in test center. Both the children of control and intervention group may have some medical problems. So as the problems are for the both groups the study results will not be much varied. | At base line and change of children's weight after one year of intervention at end line. | 
| Children's Occipital Frontal Circumference | Children's Occipital Frontal Circumference at baseline and at the end in test center. Both the children of control and intervention group may have some medical problems. So as the problems are for the both groups the study results will not be much varied. | At base line and change of children's Occipital Frontal Circumference after one year of intervention at end line. | 
| Mother's height | Mother's height at baseline and at the end in test center. Both the mothers of control and intervention group may have some medical problems. So as the problems are for the both groups the study results will not be much varied. | At base line and change of mother's height after one year of intervention at end line. | 
| Mother's height | Mother's weight at baseline and at the end in test center. Both the mothers of control and intervention group may have some medical problems. So as the problems are for the both groups the study results will not be much varied. | At base line and change of mother's weight after one year of intervention at end line. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Depression, Child Development, Stimulation, CBT, Bangladesh