CompletedNot Applicable

Reduce Childhood Maltreatment and Promote Development

Bangladesh306 participantsStarted 2015-05

Plain-language summary

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.

Who can participate

Age range

8 Months – 23 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Mothers of 8 to 23 months old children, who practice maltreatment or harsh child-discipline (screened by a previously used tool), will be included. * Children 8-23 months old with weight-for-length ≥-3 z score, MUAC ≥ 115 mm * Mothers are the primary caregivers and consented to participate. Exclusion Criteria: * severe malnutrition nutritional edema, known developmental disability, chronic illness, haemoglobin level \<8 gm/L (at enrolment). They will be referred to the nearby health facilities for necessary clinical management

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Cognitive development (composite score of cognitive,motor, language and social-emotional development of children)

Timeframe: Change from baseline at 11 months of intervention

Trial details

NCT IDNCT03031236

SponsorInternational Centre for Diarrhoeal Disease Research, Bangladesh

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-12

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