Preventing Mental Health Problems After Childhood Severe Malaria

Not Applicable

Completed

• Conditions: Malaria
• Interventions: Behavioral: Behavioral; Behavioral: Psychoeducation

• Registration Number: NCT03432039
• Lead Sponsor: Makerere University

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.

Study Timeline

• Study Start: 2018-01-09
• Study First Submitted: 2018-02-07
• Study First Submitted QC: 2018-02-12
• Study First Posted: 2018-02-13
• Primary Completion: 2019-07-31
• Study Completion: 2019-07-31
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-03
• Last Update Posted: 2020-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Behavioral intervention	Behavioral	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
Psychoeducation arm	Psychoeducation	This arm will provide information about admission procedures, story telling and a follow-up phone call

Primary Outcome Measures

Name	Time	Method
Presence of a behavioral problem	6 months post-discharge	Children whose scores on the Strength and Difficulties score for Total Problems is above 17

Secondary Outcome Measures

Name	Time	Method
Behavioral problems in the child	6 months post-discharge	Total Problems score of the Child Behavioral Checklist
Maternal anxiety and depression	6 months post-discharge	Anxiety and depression scores as measured by the Hopkins Symptom Checklist

Trial Locations

Locations (1)

Makerere University; 🇺🇬 Kampala, Uganda