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. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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12 December 2020 |
Main ID: |
NCT03432039 |
Date of registration:
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07/02/2018 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Preventing Mental Health Problems After Childhood Severe Malaria
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Scientific title:
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Preventing Long-term Mental Health Problems in Children Admitted With Severe Malaria at Naguru General Hospital in Uganda |
Date of first enrolment:
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January 9, 2018 |
Target sample size:
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120 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT03432039 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Double (Participant, Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Uganda
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- aged 1.5 to 4 years
- admitted with severe malaria necessitating admission and intravenous treatment
- signed informed consent from the caregiver. Severe malaria in this study will include;
cerebral malaria, severe malarial anemia, malaria with impaired consciousness (but not
in coma or CM) and malaria with multiple seizures.
Exclusion Criteria:
- Living more than 50km from the hospital
- pre-existing developmental delays based on the Ten Questions Questionnaire
Age minimum:
18 Months
Age maximum:
4 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Malaria
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Intervention(s)
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Behavioral: Behavioral
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Behavioral: Psychoeducation
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Primary Outcome(s)
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Presence of a behavioral problem
[Time Frame: 6 months post-discharge]
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Secondary Outcome(s)
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Behavioral problems in the child
[Time Frame: 6 months post-discharge]
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Maternal anxiety and depression
[Time Frame: 6 months post-discharge]
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Secondary ID(s)
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REC 2017-088
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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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