Preventing Mental Health Problems After Childhood Severe Malaria

Malaria Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03432039
• Other study ID #: REC 2017-088
• Status: Completed
• Phase: N/A
• Start date: January 9, 2018
• Est. completion date: July 31, 2019

Study information

• Verified date: September 2020
• Source: Makerere University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: July 31, 2019
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Months to 4 Years

Eligibility

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

Related Conditions & MeSH terms

• Malaria

Intervention

Behavioral:
• Psychoeducation
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
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.

Locations

Country	Name	City	State
Uganda	Makerere University	Kampala

Sponsors (1)

Lead Sponsor	Collaborator
Makerere University

Country where clinical trial is conducted

Uganda, 

References & Publications (2)

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. — View 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). pii: e20161965. Epub 2016 Oct 5. Erratum in: Pediatrics. 2017 Nov;140(5):null. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of a behavioral problem	Children whose scores on the Strength and Difficulties score for Total Problems is above 17	6 months post-discharge
Secondary	Maternal anxiety and depression	Anxiety and depression scores as measured by the Hopkins Symptom Checklist	6 months post-discharge
Secondary	Behavioral problems in the child	Total Problems score of the Child Behavioral Checklist	6 months post-discharge