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Completed

NCT Number: NCT03432039

Preventing Mental Health Problems After Childhood Severe Malaria

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.

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Key information

Age range

18 month–4 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Makerere University

Kampala, 7072, Uganda

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Psychoeducation

Behavioral

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.

Behavioral

Behavioral

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 outcomes

  1. Presence of a behavioral problem

    Time frame: 6 months post-discharge

    Children whose scores on the Strength and Difficulties score for Total Problems is above 17

Secondary outcomes

  1. Maternal anxiety and depression

    Time frame: 6 months post-discharge

    Anxiety and depression scores as measured by the Hopkins Symptom Checklist

  2. Behavioral problems in the child

    Time frame: 6 months post-discharge

    Total Problems score of the Child Behavioral Checklist

Sponsors and collaborators

Lead sponsor

Makerere University

Other

Registry information

Official study title

Preventing Long-term Mental Health Problems in Children Admitted With Severe Malaria at Naguru General Hospital in Uganda

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 13, 2018
Registry last updated
Sep 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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