Preventing Long-term Mental Health Problems in Children Admitted With Severe Malaria at Naguru General Hospital in Uganda
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Presence of a behavioral problem
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Months 至 4 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Living more than 50km from the hospital
- •pre-existing developmental delays based on the Ten Questions Questionnaire
研究组 & 干预措施
Psychoeducation arm
This arm will provide information about admission procedures, story telling and a follow-up phone call
干预措施: Psychoeducation (Behavioral)
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
干预措施: Behavioral (Behavioral)
结局指标
主要结局
Presence of a behavioral problem
时间窗: 6 months post-discharge
Children whose scores on the Strength and Difficulties score for Total Problems is above 17
次要结局
- Maternal anxiety and depression(6 months post-discharge)
- Behavioral problems in the child(6 months post-discharge)