Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201705002239265 Date of Approval: 26/04/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Preventing mental health problems after severe malaria
Official scientific title Preventing long-term mental health problems in children admitted with severe malaria at Mulago Hospital
Brief summary describing the background and objectives of the trial Severe malaria affects up to 5 million children annually in sub-Saharan Africa. With improved interventions, more children now survive severe malaria are left to deal with the long-term sequelae associated with the disease. Behavioural problems (e.g. anxiety, emotional problems, somatic complaints and aggressive behaviour) and mental health disorders (e.g. oppositional defiant disorder, conduct disorder and attention deficit hyperactivity disorder) occur in about 10.4% and 18.5% respectively in children who survive severe malaria. These behavioural problems if untreated can lead to severe mental health problems later in life and are associated with social and economic difficulties in adulthood like criminality, marital problems and employment difficulties. The proposed study will provide a psychoeducational behavioural intervention to mothers of children admitted with severe malaria to prevent the children from developing mental health problems after discharge. The main objective of this study is to evaluate the effect of a maternal and child psychoeducation and behavioural intervention on mental health outcomes at 6 months after discharge. The specific objectives are; 1. To evaluate the effect of the COPE intervention for parents on their children¿s mental health. 2. To evaluate the effect of the COPE intervention for parents on their own mental health.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Malaria
Purpose of the trial Prevention
Anticipated trial start date 01/06/2017
Actual trial start date 01/07/2017
Anticipated date of last follow up 31/12/2018
Actual Last follow-up date 31/12/2018
Anticipated target sample size (number of participants) 120
Actual target sample size (number of participants) 120
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Psychoeducation plus behavioral intervention Three times Up to three days after discharge This is an educational-behavioural intervention that educates the parent about the children's likely emotional and behavioural problems that may result from ICU admission. It then provides the parent with skills to deal with these problems to bring about a change in the child's behaviour. This is an intervention delivered in three phases till after discharge 60
Control Group Psychoeducation Three times Up to three days after discharge This intervention provides parents with information about the policies on the ward, games for the child and follow-up phone call explaining where the child can be taken if having any behavioral problems 60 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
a) aged 1.5 to 4 years b) admitted with severe malaria necessitating admission and intravenous treatment c) signed informed consent from the caregiver a) Living more than 50km from the hospital b) pre-existing developmental delays based on the Ten Questions Questionnaire c) pre-existing mental disorder based on baseline CBCL results. 18 Month(s) 4 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 20/04/2017 School of Medicine Research and Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Upper Mulago Hill Road Kampala 7072 Uganda
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Behavior problems measured by the SDQ a) At enrollment/baseline b) At 6 months after discharge
Primary Outcome Mother's psychological wellbeing as measured by the HSCL a) At enrollment/baseline b) At 6 months after discharge
Secondary Outcome CBCL scores a) At enrollment/baseline b) At 6 months after discharge
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mulago Hospital Upper Mulago Hill Road Kampala 7051 Uganda
FUNDING SOURCES
Name of source Street address City Postal code Country
National Institutes of Health 10 Center Drive Bethesda, MD 20892 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Makerere University College of Health Sciences Upper Mulago Hill Road Kampala 7072 Uganda University
COLLABORATORS
Name Street address City Postal code Country
Seggane Musisi Upper Mulago Hill Road Kampala 7072 Uganda
Jacque Nakitende Upper Mulago Hill Road Kampala 7072 Uganda
Richard Idro Upper Mulago Hill Road Kampala 7072 Uganda
Chandy John Indiana University, Ryan White Center for Pediatric Infectious Disease and Global Health, 1044 W. Walnut St, Indianapolis, IN 46202 United States of America
Maria Kroupina University of Minnesota, Division of Global Pediatrics, 717 Delaware St SE Minneapolis, MN 55455 United States of America
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Paul Bangirana pbangiran@yahoo.com +256772673831 Upper Mulago Hill Road
City Postal code Country Position/Affiliation
Kampala 7072 Uganda Makerere University, Department of Psychiatry
Role Name Email Phone Street address
Public Enquiries Jacque Nakitende janakitex@yahoo.com +256712851619 Upper Mulago Hill Road
City Postal code Country Position/Affiliation
Kampala 7072 Uganda
Role Name Email Phone Street address
Scientific Enquiries Paul Bangirana pbangiran@yahoo.com +256772673831 Upper Mulago Hill Road
City Postal code Country Position/Affiliation
Kampala 7072 Uganda Makerere University, Department of Psychiatry
REPORTING
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