Preventing Mental Health Problems After Childhood Severe Malaria

M

Makerere University

Status

Completed

Conditions

Malaria

Treatments

Behavioral: Psychoeducation
Behavioral: Behavioral

Study type

Interventional

Funder types

Other

Identifiers

NCT03432039
REC 2017-088

Details and patient eligibility

About

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.

Full 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.

Enrollment

120 patients

Sex

All

Ages

18 months to 4 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

120 participants in 2 patient groups, including a placebo group

Psychoeducation arm
Placebo Comparator group
Description:
This arm will provide information about admission procedures, story telling and a follow-up phone call
Treatment:
Behavioral: Psychoeducation
Behavioral intervention
Experimental group
Description:
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
Treatment:
Behavioral: Behavioral

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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