CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 306 enrolled
Drug / intervention
Psychosocial stimulation, Cognitive behavioral therapy and positive parenting practicebehavioral
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03031236
NCT03031236N/ACompleted

Effect of Integrated Management of Childhood Maltreatment, Maternal Depression, Psychosocial Stimulation and Nutritional Intervention on Child Development - A Randomized Controlled Trial

International Centre for Diarrhoeal Disease Research, Bangladesh·interventional·Posted Jan 25, 2017·Updated Jan 25, 2017

In Brief

A clinical study evaluating Psychosocial stimulation, Cognitive behavioral therapy and positive parenting practice for Maltreatment. Completed, enrolled 306 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMaltreatment
CountriesBangladesh

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedJan 25, 2017
Enrollment StartMay 1, 2015
Primary CompletionDec 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 9.4 years ago

Interventions

Psychosocial stimulation, Cognitive behavioral therapy and positive parenting practicebehavioral

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)