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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT03031236 |
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Date of registration:
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13/11/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Reduce Childhood Maltreatment and Promote Development
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Scientific title:
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Effect of Integrated Management of Childhood Maltreatment, Maternal Depression, Psychosocial Stimulation and Nutritional Intervention on Child Development - A Randomized Controlled Trial |
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Date of first enrolment:
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May 2015 |
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Target sample size:
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306 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03031236 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Bangladesh
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Contacts
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Name:
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Fahmida Tofail, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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International Centre for Diarrhoeal Disease Research, Bangladesh |
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Key inclusion & exclusion criteria
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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
Age minimum:
8 Months
Age maximum:
23 Months
Gender:
All
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Health Condition(s) or Problem(s) studied
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Maltreatment
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Intervention(s)
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Behavioral: Psychosocial stimulation, Cognitive behavioral therapy and positive parenting practice
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Primary Outcome(s)
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Cognitive development (composite score of cognitive,motor, language and social-emotional development of children)
[Time Frame: Change from baseline at 11 months of intervention]
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Secondary Outcome(s)
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Maltreatment of children by the caregivers
[Time Frame: Change from baseline at 11 months of intervention]
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folic acid status
[Time Frame: Change from baseline at 11 months of intervention]
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Retinol
[Time Frame: Change from baseline at 11 months of intervention]
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Weight
[Time Frame: Change from baseline at 11 months of intervention]
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Head circumference
[Time Frame: Change from baseline at 11 months of intervention]
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Height
[Time Frame: Change from baseline at 11 months of intervention]
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Mothers' stress and depressive symptoms
[Time Frame: Change from baseline at 11 months of intervention]
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Positive parenting practices,
[Time Frame: Change from baseline at 11 months of intervention]
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STfR per Mg/ml
[Time Frame: Change from baseline at 11 months of intervention]
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vitamin B12
[Time Frame: Change from baseline at 11 months of intervention]
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Haemoglobin
[Time Frame: Change from baseline at 11 months of intervention]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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