Maltreatment Clinical Trial
Official title:
Effect of Integrated Management of Childhood Maltreatment, Maternal Depression, Psychosocial Stimulation and Nutritional Intervention on Child Development - A Randomized Controlled Trial
Background (brief):
1. Burden: The uniqueness of each child is tremendously influenced by interaction between
nature and nurture during critical period of brain development that promotes foundation
of brain architecture through neuronal connections.
2. Knowledge gap: Young children in Bangladesh are prone to multiple physiological and
psycho-social risk factors e.g. poverty, maltreatment, malnutrition, disease, parental
illiteracy, maternal depression and lack of stimulation, all of which are preventable.
Little is reported about any comprehensive package of development that addresses most
of these early childhood risks and promotes optimum early childhood development (ECD).
3. Relevance: The aim of this study is to develop and evaluate an integrated, low cost,
and feasible center based approach that focuses on positive parenting of children
during early life that will promote early stimulation, minimize childhood maltreatment,
boost up of maternal self-esteem and healthy thinking and improve health and
nutritional (HN) status of children.
Hypothesis (if any):
This integrated intervention will promote maternal child-care practices and mental health
that will finally improve their children's growth, micro-nutrient status, early brain
development compared to control group.
Objectives:
To see the effect of an integrated intervention (ECD + HN) on growth, micro-nutrient status,
child development along with effect on maternal child-care practices and mental health.
Methods:
Randomly selected 2 groups will be identified as intervention and control (150 mothers'
from15 clusters in each group). Mothers of 8-23 months old children living in slums and
practice harsh child-disciplining will be identified as study population. The mothers of
intervention (ECD+HN) group will receive fortnightly group sessions for 11 months that will
include combined messages on a) psycho-social stimulation, b) positive parenting to prevent
child maltreatment and c) cognitive behavioral therapy (CBT) for positive thinking, d)
health and nutrition messages and e) 15 micro-nutrient sprinkle supplement.(90 sachets of
over 6 month-period). The control group will only receive the usual health messages provided
by the government.
Outcome measures/variables:
- Children's cognitive, motor, language and socio-emotional development; anthropometry;
hemoglobin and micro-nutrient status (serum vitamin B12, iron and folic acid)
- Mother s' parenting practices, depressive symptoms, self-esteem and child-maltreatment.
Hypothesis to be tested:
This integrated intervention will a) improve children's growth, hemoglobin, micro-nutrient
status (vitamin B12 and folic acid), cognitive, motor, language and social-emotional
development, b) minimize maltreatment of children by parents, c) improve positive parenting
and d) reduce mothers' stress and depressive symptoms compared to control group.
Objectives:
Primary: This integrated intervention will
- Improve cognitive, motor, language and social-emotional development of children
- Minimize maltreatment of children by the caregivers
Secondary: This integrated intervention will bring following benefits in intervention group
compared to control group- On children-
- Improve height, weight and head circumference
- Improve hemoglobin, vitamin B12 and folic acid status, On mothers (primary caregivers)
- Reduce mothers' stress and depressive symptoms
- Improve positive parenting practices
Background of the Project including Preliminary Observations:
The rate of global acute malnutrition is 16% while the rate of stunting in Bangladesh is as
high as 41% in <five yrs children. Moreover, the children in Bangladesh are either deficient
in different micro-nutrients like iron 10.7% and iodine 34% or have inadequate
micro-nutrients in their diets like vitamin B12 and folate which is less than 50%. Many
children in developing countries fail to reach their developmental potential due to lack of
cognitive stimulation and Bangladeshi children have limited access to play materials and
activities.
According to Walker and colleagues 300 million children are exposed to violence globally.
Our unpublished data show that 32% of children <2 years are subjected to maltreatment and
harsh punishment in Bangladesh.
Depression is one of the leading causes of disease burden for women and children of these
mothers may suffer from behavioral problems.. Depression is reported as a leading cause of
disease burden for women aged 15-44 years in all countries. The South Asia has the least
woman-friendly societies in the world. Maternal depression is becoming a major public health
problem in these societies, partly due to gender roles and practices and partly to poverty.
Depression indicates state of mind that causes symptoms like crying spells, sleeping
problems, depressed mood, irritability, fatigue, anxiety, poor concentration and
interpersonal hypersensitivity, and these can range from mild to severe in nature. Maternal
depression not only affects mothers' health, evidenced by poorer nutrition, higher suicide
attempts and self harm but also results in poor health and developmental outcomes of their
children.
In Bangladesh prevalence of anxiety and depressive symptoms are as high as 18-33% and we
found a significant association with child maltreatment in an urban community on). Rahman et
al. tested an innovative model of community-based management of depression using Cognitive
Behavioral Therapy (CBT) in Pakistan and reported improvement in maternal depression 6
months postpartum. Considering similar family structure, religion and culture between
Bangladesh and Pakistan, it is likely that the program will work in Bangladesh too.
Despite prevalent child maltreatment in Bangladesh, there are very few interventions to
reduce maltreatment and those for children under 5 yrs of age are even rarer. Similarly,
though attention has been diverted to ECD for several years now, very few of those programs
address children under 3 yrs of age. Study design would probably be the 1st intervention
using a robust research method to test the efficacy of an integrated method to address ECD,
child maltreatment as well as health and nutrition of young children. Investigators will
modify existing curriculum to further focus on child maltreatment. Investigators have
targeted poor families from urban slums who are deprived of such services but face most of
the risk factors and hope to improve their families' condition using low-cost intervention.
Researchers have targeted the mothers as study participants who also primary caregiver of a
child especially at younger age and have a major role in the child development. Mothers are
also more vulnerable for depression than the fathers in Bangladeshi culture.
In addition, there is no culturally appropriate tool to assess child maltreatment in
Bangladesh. In this project researchers attempt to modify or adapt existing instruments or
if needed develop new tools suitable for use in Bangladesh.
Research Design and Methods
Population and sample size:
This study will be conducted in the semi-urban area (preferably in Kamalapur) of Dhaka,
Bangladesh. Total sample is 10 mother-child duos in randomly selected 30 clusters ( n=300),
half of which (n=150) will be beneficiaries from the intervention.
Plan of work: The intervention package will be piloted in the non study community for its
feasibility and will be modified accordingly. The selected mother-child duos will be invited
to field office for baseline assessments. Intervention group will be invited to join the
center-based group sessions fortnightly for one year, the control group will receive
existing government health messages. Both the groups will receive free health service from
study medical officer for acute illnesses. After a year, final assessments will be done in
both the groups. At baseline and end line mother-child interaction will be observed in a
sub-sample of the population.
Procedures:
It will be a cluster-randomized trial. Clusters will be formed based on number of household
members (those using the same cooking pot) as well as geographical boundary. On average
there will be 150-200 households in each cluster, but there may be some variation in
household numbers per cluster and per stratum.Total sample will be 10 mother-child duos in
randomly selected 30 clusters (n=300), half of which (n=150) will be beneficiaries from the
intervention.
Plan of work: The intervention package will be piloted in the non study community for its
feasibility and will be modified accordingly. The selected mother-child duos will be invited
to field office for baseline assessments. Intervention group will be invited to join the
center-based group sessions fortnightly for 1 year, the control group will receive existing
government health messages. Both the groups will receive free health service from study
medical officer for acute illnesses. After a year, final assessments will be done in both
the groups. At baseline and end line mother-child interaction will be observed in a
sub-sample of the population. At the beginning of the study, 4 Focus group discussions of
(8-10 non-study mothers) will be conducted in the community to know about the mothers'
parenting practices. At the middle of the study qualitative information (case report and 30
In-Depth Interviews) will be collected form the intervened mothers about the intervention
package they are receiving. Intervened mothers will be interviewed at their home according
to their time availability. Key Informant's Interview (KII) will be conducted after a year
from 2 play leaders (who will deliver the intervention) and 2 supervisors (who will train
the play leaders and monitored them). Interviews will be taken and tape recorded with
consent of the participants.
1. Preparatory works: At the first phase researchers will select the site and also
complete the process of 'Ethical Review' of the project.
Screening and enrollment: After taking the consent, screening of mothers of 8 to 23
months old children, who practice harsh discipline will be conducted in 30 identified
clusters by trained health workers using ISPCAN Child Abuse Screening Tool-Parent
Version (ICAST-P). Researchers have already used the modified version of these tools in
Bangladesh. According to primary investigation there are 10% mothers having 8 to 23
months old children in study field site. With this estimation to get 10 eligible
mothers from each cluster researcher group have to screen 100 mothers. Mothers who will
fulfill the study enrollment criteria will be offered to join the study and will be
invited to the test centers for baseline assessments.
At the same time research group will start developing the study materials:
For intervention: Development and piloting of following manuals, that already exist and
needs further simplification and adaptations
- Psycho-social stimulation for individual visits
- Cognitive behavioral therapy For assessments: Cultural adaptation, Standard
Operating Procedures (SOPs) preparation and field testing of following tools
- Bayley Scale of Infant and Toddler Development (Already adapted, we have to take
permission from Pearson's to use it)
- Field testing and adaptation of ISPCAN Child Abuse Screening Tool -Parent Version
(ICAST-P)
- Qualitative questionnaires
- Observational tools
Tools that are adapted, tested and ready to use
- Parenting questionnaire
- Home observation for measurement of environment (HOME)
- Rosenberg Self Esteem Scale
- CES-D to measure depressive symptoms
- Socio-economic status (SES) questionnaire
- Wolke's Behavior Rating scale
- Anthropometric measurements
2. Baseline assessment:
On children:
Bayley Scales of Infant and Toddler Development (Bayley-III) will be used to assess
cognitive, language and motor development of the children. The test has been used in
many developing countries, and has been the instrument of choice for much nutrition and
child development research at this age in other countries like Indonesia and Brazil.
The Bayley has often been sensitive to changes following interventions. Because the
Bayley has not been standardized in Bangladesh, researcher will not compare these
children's scores with the test norms or children of other countries. Study aim is only
to compare the development of groups of children within the same community. Bayley
usually takes about an hour to test the children.
The children's behavior during the Bayley tests will be rated on five 9-point scales
using a modified version of the scales developed by Wolke (1990). These ratings include
infants' activity (very still=1 to overactive=9), emotional tone (unhappy=1 to radiates
happiness=9), approach or responsiveness to examiner in the first 10 minutes
(avoiding=1to friendly and inviting=9), cooperation with test procedure (resists all
suggestions=1to always complies=9), and vocalization (very quiet=1to constant
vocalization=9). The scale has been used in several studies in Bangladesh and was
sensitive to intervention effects .
Anthropometry: Mother and child's anthropometric measurements (height and weight of
mothers; length/height, weight, MUAC and head circumference of children) will be
assessed at using standard procedures.
On mothers':
Maternal 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 this research team and by others as a valid
instrument.
Information on child maltreatment and neglect: The International Society for the
Prevention of Child Abuse and Neglect (ISPCAN) has developed ISPCAN Child Abuse
Screening Tool- Parent Version (ICAST-P) that has been widely used in developing
countries, like India and Jamaica. This research group already used modified version of
this tool in Bangladesh on hospital mothers.
Measurement of maternal depressive symptoms will be done using Center for Epidemiologic
Studies Depression Scale (CES-D). This tool has been used in Bangladesh and South-East
Asian countries.
Quality of stimulation at home was assessed using Caldwell's Home Observation for
Measurement of Environment (HOME) which was modified for Bangladesh and was used in
other studies by the same research team.
Other measurements: These following measures will be collected as covariates -
Socioeconomic status: On enrollment information will be collected on the family's
assets (furniture e.g. bed/tables/chairs, electrical household equipment's e.g.
radio/TV/fan, farm animals, vehicles e.g. rickshaw/boat/bicycle/motorbike, etc.),
housing condition (type of roof, floor and walls), access to water and sanitation,
electricity, crowding condition, and parental education and occupation. An asset
quintile will be created from all available assets available at household level.
Observational tools: Structured observation checklist will be used to see mother-child
interaction Qualitative assessments will be used to conduct focus group discussion, in
depth interviews and case reports.
3. Intervention:
It will be a low cost intervention focusing on building awareness among population at risk
through hands on training delivered by trained health workers with minimum educational level
and low salary. Our previous experience shows that it is possible to train paraprofessionals
to provide intervention of this intensity. We have also shown that psycho-social stimulation
provided for 10 or 12 months can improve the development and behavior of children
significantly. Two weeks training and one week's field practice will be required to train
these staff. We will train the play leaders regarding the whole intervention package
including stimulation, Cognitive Behavioral Therapy, health and nutrition messages that
include infant and young child feeding practices, good hygiene practice, and positive
parenting messages (stimulation, learning through play, love and affection). There will be
one-hour sessions fortnightly for 11 months. Attending 2 sessions per month is feasible for
the mothers. This intervention will address the major risk factors e.g. negative parenting,
lack of stimulation, child maltreatment, malnutrition, maternal stress/depressive symptoms,
faulty care-seeking practices due to knowledge gap, etc. using a combined package.
There will be a combination of 3 types of interventions:
(i) Early stimulation and prevention of maltreatment through positive parenting, boosting up
of maternal self-esteem and stress management (ECD): Psycho-social stimulation intervention
will follow a set of culturally appropriate, semi-structured, child's age appropriate
curriculum. This integrated approach will be given in groups of mothers and child. During
the session the field-workers will show the mothers how to play with home-made toys and
books and interact with their children in a way to promote their development. Along with the
stimulation program, the field workers will also provide some advice regarding positive
parenting and boosting up maternal self esteem and stress management. Care will be taken to
appreciate mothers for their activities and positive reinforcement will be strongly
encouraged. The developmental activities will be conducted in a playful manner and not as a
work-oriented activity. The activities in the curriculum will be ordered by difficulty level
and the health workers will be trained to choose the level for each child according to their
ability to do the activities.
(ii) Health education and sprinkles supplementation (HN): The participants will receive
health and nutrition messages to improve children's health. In addition children will
receive multiple micro-nutrient powder (Vitamin A 400 µg, vitamin D 5 µg, vitamin E 5 mg,
vitamin C 30 mg, thiamine 0.5 mg, riboflavin 0.5 mg, niacin 6 mg, pyridoxine 0.5 mg, vitamin
B12 0.9 mg, folate 150 µg, iron 10 mg, zinc 4.1 mg, copper 0.56 mg, selenium 17.0 µg and
iodine 90 µg) supplementation at household level (90 sachets of over 6 month-period).
(iii) Cognitive Behavioral Therapy: Intervention to help mothers change their negative
behaviour and to improve self care, child care, income generation activities, will follow
the "Thinking Healthy Program" model of Rahman and colleague using cognitive behavior
therapy (CBT). CBT will improve maternal behaviour leading to "positive parenting" and
prevention of maltreatment. Cognitive Behavioral Therapy is an "evidence-based and
structured form of talking therapy that aims to alter the cycle of unhelpful or unhealthy
thinking (cognition) and the resulting undesirable actions (behavior)." 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.This approach with rural mothers of similar context showed positive impact on child
outcome in Pakistan, which is culturally and economically similar to Bangladesh.
CBT is aimed to alter the cycle of negative thinking of people to positive direction. The
cycle of negative thoughts usually breaks in two ways by using Cognitive and Behavioral
aspect of the therapy -
- Cognitive aspect of CBT: This focuses on altering ways of thinking of a person (mother)
that includes thoughts, beliefs, ideas, attitudes, assumptions, mental imagery, and
ways of directing her attention.
- Behavioral aspect of CBT: This focuses on helping the mother to face the challenges and
the opportunities that facilitates child-raising with a sound and clear mind- and then
to take necessary actions that are likely to have desired outcomes.
This model is proven to be an effective approach in breaking the cycle of depression and
improving confidence, coping strategies and assertiveness in poor community with low
resource setting. The cycle is broken through two ways of CBT- cognitive aspect (directing
attention to positive direction) and behavioral aspect (helping to meet challenges).
d) Final assessment, data entry and data analysis: After 11 months of intervention, the
participants will be invited again in the centre for end line assessment. The same
assessment tools will be used as in the base line. Simultaneous data entry will continue in
SPSS software. After data cleaning, preliminary analysis will be done according to following
plan.
All the baseline variables will be used to compare between lost and tested groups as well as
the intervention and control groups. The two time-point assessment will also provide
information about within group changes. Some variables e.g. HOME, mother-child interaction,
parenting, childcare etc. will be used either as mediator or as outcome in separate analyses
Outcome Variables:
On Mothers-
1. Maternal stress and depressive symptoms using CES-D at baseline and at the end.
2. Self Esteem assessment using Rosenberg Self Esteem Scale at baseline and at the end in
test centre
3. Information about child maltreatment by parents will be collected at baseline during
screening at home and at the end.
4. Home observation for measurement of environment (HOME) at household level, twice (at
baseline and at the end)
On Children-
1. Child's cognitive, motor and language assessment using Bayley-III and behavioral
assessment during test using Wolke's Behavior Rating Scale, at baseline and at the end
in test centre. Children will accompany their mothers to the centre. (45 min)
2. Children's Micronutrient status (vitamin B12 and folic acid) at baseline and at the end
in test centre
3. Children's Hemoglobin status
4. Children's height, weight, MUAC, head circumference at baseline and at the end
Covariates-
1. Socio-economic variables (asset index/ quintile)
2. Demographic variables (housing/ sanitation)
3. Maternal nutritional status (BMI)
4. Child's age and sex
5. Compliance on micro-nutrients and dietary recall
6. Morbidity Sample Size Calculation and Outcome (Primary and Secondary) Variable(s)
Considering 5% level of significance, 80% power, an improvement of 0.4 SD in children's
developmental outcome based on our previous experiences, an ICC of 0.01 and 30% drop outs,
we need to enroll 150 mother-child duos in each group as per equation below- 2(SD)2 n =
---------------- X f (αβ) (M1-M2) 2
n: sample required, SD: 16 (based on previous data of Bayley Score) α: 5% level of
significance β: 80% power f= α*β M1-M2 = Difference = 6.4 points (based on previous studies)
So the calculated n=100
Considering the clustering we need to adjust this sample size by multiplying the above value
(100) by the design effect.
Design Effect = 1 + [(m-1) * ICC m corresponds to the average number of infants per cluster.
Assuming there are on average 10 mother-child duos/cluster.
Using ICC = 0.01, the design effect = 1 + [(10-1) * ICC = 1 + 0.9 = 1.09 Therefore new
sample size = 100*1.09= 109 per group , considering 30% drop-out the sample size per group
is around 150 infants in stimulation group and 150 infants in control group.
Data Analysis
icddr,b scientists and co-investigators of this research project will analyze the data using
Stata/SPSS. All data will be checked for normality. Log transformation will be done if not
normally distributed. Indices will be created where it is required (eg: SES index, housing
index etc). Pearson's correlations will be conducted to examine the association between age
of the child and each developmental measure. A comparison will be done between the
socio-demographic characteristics of the intervened and control groups using t-test for
continuous variables and χ2 for categorical variables. Partial correlation will be used
controlling age and sex to examine association of different covariates with developmental
scores.
Finally, multi-level regression analyses will be done. In each regression analysis, the
outcome will be the final developmental score, with age at enrollment, the relevant initial
scores, and intervention as predictors. Again, comparison will be done between the treatment
effect in intervention and control groups. All variables that will be different between
intervention and control groups at baseline and will correlate with the developmental
outcomes and will address high co-linearity among the covariates in all analyses.
The main outcomes are children's cognitive, language and motor development measured on
Bayley Scales of Infant and Toddler Development. In addition it is expected that an
improvement in growth, home stimulation and mother's positive parenting. It is also expected
that improvement of the hemoglobin and micro-nutrient status (vitamin B12 and folic acid)
over 150 children in the intervention group by the end of the project. At the same time it
is expected of a reduction on mothers' stress and depressive symptom and rate of
maltreatment of children by parents. A cost analysis will be conducted based on the success
indicators, cost per successful outcome will be calculated from total cost of intervention
program.
Data Safety Monitoring Plan (DSMP)
Researcher group do not expect the low risk activities of this study to put the study
population at increased risk of adverse outcomes, however any human activity can have
unforeseen untoward consequences. researchers will actively monitor the impact of the
intervention on the population. The primary objective of these evaluations is to understand
practices, knowledge, and attitudes towards the interventions. researchers will include
questions in the evaluations that ask if they have noted any adverse outcomes.
If the field team learns of any adverse outcomes they will be trained to report them to the
study team the same day they learn of them.
Ethical Assurance for Protection of Human rights
The project will have to be approved by the Institutional Review Board of icddr,b.
Investigator group will collect written informed consent in Bengali from the parents before
starting data collection. Research group will ensure confidentiality when collecting data on
sensitive issues like maternal depression. Hard copies of the data will be kept in a locked
cabinet only accessible to the investigators. The electronic data will not have the name and
other identifiable information. Clinically depressed mothers will be referred to counsellors
or psychiatrists as needed. Children with mental retardation or developmental disabilities
will be referred to proper places for treatment.
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