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Preventing Mental Health Problems After Childhood Severe Malaria

Primary Purpose

Malaria

Status
Completed
Phase
Not Applicable
Locations
Uganda
Study Type
Interventional
Intervention
Psychoeducation
Behavioral
Sponsored by
Makerere University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Malaria

Eligibility Criteria

18 Months - 4 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Makerere University

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Psychoeducation arm

Behavioral intervention

Arm Description

This arm will provide information about admission procedures, story telling and a follow-up phone call

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

Outcomes

Primary Outcome Measures

Presence of a behavioral problem
Children whose scores on the Strength and Difficulties score for Total Problems is above 17

Secondary Outcome Measures

Maternal anxiety and depression
Anxiety and depression scores as measured by the Hopkins Symptom Checklist
Behavioral problems in the child
Total Problems score of the Child Behavioral Checklist

Full Information

First Posted
February 7, 2018
Last Updated
September 3, 2020
Sponsor
Makerere University
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1. Study Identification

Unique Protocol Identification Number
NCT03432039
Brief Title
Preventing Mental Health Problems After Childhood Severe Malaria
Official Title
Preventing Long-term Mental Health Problems in Children Admitted With Severe Malaria at Naguru General Hospital in Uganda
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
January 9, 2018 (Actual)
Primary Completion Date
July 31, 2019 (Actual)
Study Completion Date
July 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Makerere University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malaria

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Psychoeducation arm
Arm Type
Placebo Comparator
Arm Description
This arm will provide information about admission procedures, story telling and a follow-up phone call
Arm Title
Behavioral intervention
Arm Type
Experimental
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Psychoeducation
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral
Intervention Description
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.
Primary Outcome Measure Information:
Title
Presence of a behavioral problem
Description
Children whose scores on the Strength and Difficulties score for Total Problems is above 17
Time Frame
6 months post-discharge
Secondary Outcome Measure Information:
Title
Maternal anxiety and depression
Description
Anxiety and depression scores as measured by the Hopkins Symptom Checklist
Time Frame
6 months post-discharge
Title
Behavioral problems in the child
Description
Total Problems score of the Child Behavioral Checklist
Time Frame
6 months post-discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Months
Maximum Age & Unit of Time
4 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Makerere University
City
Kampala
ZIP/Postal Code
7072
Country
Uganda

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27940786
Citation
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.
Results Reference
background
PubMed Identifier
27030124
Citation
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.
Results Reference
background
PubMed Identifier
34120616
Citation
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.
Results Reference
derived

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Preventing Mental Health Problems After Childhood Severe Malaria

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