Reduce Childhood Maltreatment and Promote Development

NCT03031236 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 306

Last updated 2017-01-25

No results posted yet for this study

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.

Conditions

  • Maltreatment

Interventions

BEHAVIORAL

Psychosocial stimulation, Cognitive behavioral therapy and positive parenting practice

The mothers of intervention (ECD+HN) group will receive fortnightly group sessions for 12 months that will include combined messages on a) psychosocial stimulation, b) positive parenting to prevent child maltreatment and c) cognitive behavioural therapy (CBT) for positive thinking, d) health and nutrition messages and e) 15 micronutrient sprinkle supplement.(90 sachets of over 6 month-period)

Sponsors & Collaborators

  • UBS Optimus Foundation

    collaborator OTHER
  • International Centre for Diarrhoeal Disease Research, Bangladesh

    lead OTHER

Principal Investigators

  • Fahmida Tofail, PhD · International Centre for Diarrhoeal Disease Research, Bangladesh

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
8 Months
Max Age
23 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • Bangladesh

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03031236 on ClinicalTrials.gov