Preventing Mental Health Problems After Childhood Severe Malaria
September 3, 2020 updated by: Makerere University
Preventing Long-term Mental Health Problems in Children Admitted With Severe Malaria at Naguru General Hospital in Uganda
This is a randomized trial in which caregivers of children suffering from malaria will be assigned to two treatment conditions to prevent mental health problems in the children.
A psycho-education arm (control) and a behavioral arm (intervention).
Pre- and post-intervention assessments for behavioral problems in the child and mother will be carried out.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This study is designed to prevent mental health problems in children after an episode of severe malaria.
The effect of the intervention on the mother's psychological wellbeing will also be assessed.
Both caregivers and children will be assessed on the ward before being randomly assigned to the treatment arms.
The interventions in both arms will be done in three phases with the third phase being done at home after discharge.
Post-intervention assessments will be done on both the caregivers and mothers 6 months after discharge.
Study Type
Interventional
Enrollment (Actual)
120
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Kampala, Uganda, 7072
- Makerere University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 4 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Placebo Comparator: Psychoeducation arm
This arm will provide information about admission procedures, story telling and a follow-up phone call
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This intervention has three phases occurring the same time as the Psychoeducation intervention.
Phase I provides verbal and written information about the paediatric acute care unit services and policies.
Phase II consists of: (a) verbal and written information about the general paediatric unit and its policies, and (b) a parent-child activity having ''control'' activities like reading a story not related to hospital stay.
Phase III of the control program consists of a telephone call 2-3 days after discharge during which time mothers were informed that they should contact their primary healthcare providers if their children were having any problems or unusual symptoms.
They also were asked to comment on their children's hospital stays during this telephone call.
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Experimental: Behavioral intervention
This arm will provide information about what invasive procedures maybe given to the child, the emotional and behavioral reactions of the child while on the ward, games and stories that the child can engage with the mother and a follow-up phone call
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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.
Phase I will be delivered within 6 to 16 hours of admission to the hospital where caregivers are provided with information about the child's likely emotional reactions during admission in hospital.
Phase II will be delivered within 2 to 16 hours of transfer to the general ward and will consist of: (a) verbal and written information to reinforce information provided in Phase I and (b) a parent-child skills building activities.
Phase III of the COPE intervention program will occur 2 to 3 days after hospital discharge and will consist of a telephone call during which a 5 minute script will be read that reinforces young children's typical post-discharge emotions and behaviours and parenting behaviours which would continue to facilitate positive coping outcomes in their children.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Presence of a behavioral problem
Time Frame: 6 months post-discharge
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Children whose scores on the Strength and Difficulties score for Total Problems is above 17
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6 months post-discharge
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Maternal anxiety and depression
Time Frame: 6 months post-discharge
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Anxiety and depression scores as measured by the Hopkins Symptom Checklist
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6 months post-discharge
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Behavioral problems in the child
Time Frame: 6 months post-discharge
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Total Problems score of the Child Behavioral Checklist
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6 months post-discharge
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Ssenkusu JM, Hodges JS, Opoka RO, Idro R, Shapiro E, John CC, Bangirana P. Long-term Behavioral Problems in Children With Severe Malaria. Pediatrics. 2016 Nov;138(5):e20161965. doi: 10.1542/peds.2016-1965. Epub 2016 Oct 5. Erratum In: Pediatrics. 2017 Nov;140(5):null.
- Idro R, Kakooza-Mwesige A, Asea B, Ssebyala K, Bangirana P, Opoka RO, Lubowa SK, Semrud-Clikeman M, John CC, Nalugya J. Cerebral malaria is associated with long-term mental health disorders: a cross sectional survey of a long-term cohort. Malar J. 2016 Mar 31;15:184. doi: 10.1186/s12936-016-1233-6.
- Bangirana P, Birabwa A, Nyakato M, Nakitende AJ, Kroupina M, Ssenkusu JM, Nakasujja N, Musisi S, John CC, Idro R. Use of the creating opportunities for parent empowerment programme to decrease mental health problems in Ugandan children surviving severe malaria: a randomized controlled trial. Malar J. 2021 Jun 13;20(1):267. doi: 10.1186/s12936-021-03795-y.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 9, 2018
Primary Completion (Actual)
July 31, 2019
Study Completion (Actual)
July 31, 2019
Study Registration Dates
First Submitted
February 7, 2018
First Submitted That Met QC Criteria
February 12, 2018
First Posted (Actual)
February 13, 2018
Study Record Updates
Last Update Posted (Actual)
September 4, 2020
Last Update Submitted That Met QC Criteria
September 3, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC 2017-088
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.