Clinical trial NCT03432039: 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
Overall status: COMPLETED
Phase: NA
Conditions: Malaria
Lead sponsor: Makerere University
Sponsor class: OTHER
First posted: 2018-02-13
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Presence of a behavioral problem
timeFrame: 6 months post-discharge
Secondary outcomes:
measure: Maternal anxiety and depression
timeFrame: 6 months post-discharge
measure: Behavioral problems in the child
timeFrame: 6 months post-discharge
Other outcomes:
Locations:
city: Kampala
country: Uganda
facility: Makerere University
Study officials:
References:
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.
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.
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.